<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02229474</url>
  </required_header>
  <id_info>
    <org_study_id>IDEA_TANZANIA_CST1</org_study_id>
    <nct_id>NCT02229474</nct_id>
  </id_info>
  <brief_title>IDEA Study Cognitive Stimulation Therapy (CST) Trial in Tanzania</brief_title>
  <acronym>IDEA</acronym>
  <official_title>Identification and Intervention for Dementia in Elderly Africans (IDEA) Study: CST Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Keith Gray</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Grand Challenges Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ibadan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kilimanjaro Christian Medical Centre, Tanzania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northumbria Healthcare NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northumbria Healthcare NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trials of cognitive stimulation therapy (CST) in Tanzania is part of the larger&#xD;
      Identification and Intervention for Dementia in Elderly Africans (IDEA) study.&#xD;
&#xD;
      The overall aim of the IDEA study is to set up and evaluate sustainable programmes to&#xD;
      facilitate diagnosis of, and therapy for, people with dementia led by local communities in&#xD;
      sub-Saharan Africa. We aim seek to improve quality of life for people with dementia and their&#xD;
      caregivers.&#xD;
&#xD;
      Within this trial of CST, we hypothesise that CST can significantly improve the quality of&#xD;
      people with dementia and their carers living in Africa&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our project will address three specific challenges: 1) Integrate screening and core packages&#xD;
      of services into routine primary health care. 2) Provide effective and affordable&#xD;
      community-based care and rehabilitation. 3) Develop effective treatment for use by&#xD;
      non-specialists, including lay healthcare workers with minimal training.&#xD;
&#xD;
      Dementia is under-diagnosed in sub-Saharan Africa (SSA) and treatment is rarely accessed or&#xD;
      available. The burden of dementia on caregivers is high, with loss of income, and&#xD;
      psychosocial stress common. However, large scale screening for dementia in such a setting is&#xD;
      neither affordable nor sustainable. The purpose of this 3 year project is to provide a&#xD;
      sustainable mechanism for diagnosis and therapeutic intervention for people with dementia. We&#xD;
      will use 2 complimentary, rural study sites, 1 in Nigeria, West Africa and 2 in Tanzania,&#xD;
      East Africa. As a consequence our results should be generalizable to all SSA. Our approach is&#xD;
      inexpensive and will have applicability to other low- and middle-income countries.&#xD;
&#xD;
      During Phase I we will validate a screening tool, previously developed by members of our&#xD;
      study team from data collected in Tanzania, and carry out a pilot study of the benefits of&#xD;
      cognitive stimulation therapy (CST) when used in SSA for those already identified with&#xD;
      dementia. During both of these activities we will initiate training of local healthcare&#xD;
      workers in diagnosis and management of people with dementia. In Phase II we will engage with&#xD;
      local communities to raise awareness of dementia. Building on previous work at both study&#xD;
      sites, we will initiate poster, newspaper and radio advertising and use mobile phone text&#xD;
      messaging services (for relevant healthcare personnel) to increase awareness of the need to&#xD;
      diagnose and intervene at an early stage. We will empower local private pharmacies to help&#xD;
      identify people with dementia, a relationship which will ultimately be mutually beneficial&#xD;
      through the supply of medicines to treat risk factors for dementia, such as hypertension. We&#xD;
      will engage with local community leaders and government officials to assist us in this&#xD;
      awareness raising, an approach that has proven successful in previous studies by our team in&#xD;
      SSA. One of our study team (Dr Mushi (DM)) is a social scientist based in Tanzania and during&#xD;
      Phase II we will conduct qualitative research into attitudes and beliefs surrounding dementia&#xD;
      and identify any barriers to diagnosis in both sites. The results of this research will be&#xD;
      fed back to inform other phases of the study. Finally, in phase III we will initiate a&#xD;
      program of community based CST led by local occupational therapists (OTs) and nurse&#xD;
      specialists. OTs and nurses will train caregivers in CST techniques and we hope that the&#xD;
      training will ultimately be led by caregivers allowing such therapy to become sustainable&#xD;
      within communities in the longer term. We will evaluate changes in cognition in people with&#xD;
      dementia, and quality of life (QOL) in both people with dementia and their caregivers,&#xD;
      post-intervention. We will carry out a full economic evaluation of the effect of our program,&#xD;
      to be led by a heath economist based at Newcastle University, United Kingdom.&#xD;
&#xD;
      This protocol cover the CST trial (Phase III of the study) in Tanzania&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>World Health Organization Brief Quality of Life Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>World Health Organization Brief Quality of Life Scale</measure>
    <time_frame>Immediately post-intervention</time_frame>
    <description>The WHOQOL-Bref will assess quality of life in patients and carers. The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Brief Quality of Life Scale</measure>
    <time_frame>Four weeks post intervention</time_frame>
    <description>The scale will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification and Intervention for Elderly Africans Cognitive Screen</measure>
    <time_frame>Baseline</time_frame>
    <description>The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adapted Alzheimer's Disease Assessment Scale-cognitive Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Burden Interview</measure>
    <time_frame>Baseline</time_frame>
    <description>The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification and Intervention for Elderly Africans Cognitive Screen</measure>
    <time_frame>Immediately post-intervention</time_frame>
    <description>The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adapted Alzheimer's Disease Assessment Scale-cognitive Scale</measure>
    <time_frame>Immediately post-intervention</time_frame>
    <description>The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>Immediately post-intervention</time_frame>
    <description>The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Burden Interview</measure>
    <time_frame>Immediately post-intervention</time_frame>
    <description>The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>CST intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CST Intervention</intervention_name>
    <description>The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life. Sessions will be led and facilitated by a study nurse or occupational therapist. The sessions will be held at a local health centre of village hall.</description>
    <arm_group_label>CST intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anyone with dementia living within the study site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The participant and the family should have consented to take part in the study.&#xD;
&#xD;
          -  Unable to travel to the centre where the CST sessions will be held due to physical&#xD;
             impairment (e.g. bedbound or immobile)&#xD;
&#xD;
          -  After assessment by the study doctor, deemed unable to engage in CST sessions (e.g.&#xD;
             follow instructions and participate in activities) due to severe physical or cognitive&#xD;
             impairment.&#xD;
&#xD;
          -  Profound deafness&#xD;
&#xD;
          -  Total blindness&#xD;
&#xD;
          -  Aphasia - they should be able to understand verbal communication and communicate&#xD;
             verbally (mild impairments are acceptable).&#xD;
&#xD;
          -  The participant should be able to sit in a group setting for 1 hour.&#xD;
&#xD;
          -  There should not be agitation, depression or psychosis to an extent that the person&#xD;
             would not be able to tolerate spending time with other people in a group setting.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adesola Ogunniyi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ibadan, Ibadan, Nigeria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard W Walker, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Northumbra Healthcare NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Delare Mushi</last_name>
    <role>Study Director</role>
    <affiliation>Kilimanjaro Christian Medical University College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Catherine L Dotchin, MD</last_name>
    <role>Study Director</role>
    <affiliation>Northumbria Healthcare NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William K Gray, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Northumbria Healthcare NHS Foundaion Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hai district DSS</name>
      <address>
        <city>Moshi</city>
        <state>Kilimanjaro</state>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <reference>
    <citation>Longdon AR, Paddick SM, Kisoli A, Dotchin C, Gray WK, Dewhurst F, Chaote P, Teodorczuk A, Dewhurst M, Jusabani AM, Walker R. The prevalence of dementia in rural Tanzania: a cross-sectional community-based study. Int J Geriatr Psychiatry. 2013 Jul;28(7):728-37. doi: 10.1002/gps.3880. Epub 2012 Sep 20.</citation>
    <PMID>22996739</PMID>
  </reference>
  <reference>
    <citation>Gray WK, Paddick SM, Kisoli A, Dotchin CL, Longdon AR, Chaote P, Samuel M, Jusabani AM, Walker RW. Development and Validation of the Identification and Intervention for Dementia in Elderly Africans (IDEA) Study Dementia Screening Instrument. J Geriatr Psychiatry Neurol. 2014 Jun;27(2):110-8. doi: 10.1177/0891988714522695. Epub 2014 Feb 26.</citation>
    <PMID>24578459</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <results_first_submitted>April 6, 2017</results_first_submitted>
  <results_first_submitted_qc>September 14, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 9, 2018</results_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Northumbria Healthcare NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>William Keith Gray</investigator_full_name>
    <investigator_title>Dr William Gray</investigator_title>
  </responsible_party>
  <keyword>Dementia</keyword>
  <keyword>Cognitive Stimulation Therapy</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Cognitive impairment</keyword>
  <keyword>Africa</keyword>
  <keyword>Tanzania</keyword>
  <keyword>Nigeria</keyword>
  <keyword>Low- and Middle-income countries</keyword>
  <keyword>Non-pharmacological intervention</keyword>
  <keyword>Task-shifting</keyword>
  <keyword>Cognitive screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will publish our findings in academic journals and state that we will make anonymized participant level data available in the manuscript, upon request to the authors.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CST Intervention</title>
          <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life. Sessions will be led and facilitated by a study nurse or occupational therapist. The sessions will be held at a local health centre of village hall.</description>
        </group>
        <group group_id="P2">
          <title>Group 2</title>
          <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CST Intervention</title>
          <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.&#xD;
CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve outcomes</description>
        </group>
        <group group_id="B2">
          <title>Group 2</title>
          <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81" lower_limit="76" upper_limit="86"/>
                    <measurement group_id="B2" value="80" lower_limit="74" upper_limit="86"/>
                    <measurement group_id="B3" value="80" lower_limit="76" upper_limit="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>World Health Organization Brief Quality of Life Scale</title>
        <description>The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale</description>
        <time_frame>Baseline</time_frame>
        <population>Analysis for QOL data comparing pre- and post intervention scores</population>
        <group_list>
          <group group_id="O1">
            <title>CST Intervention</title>
            <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.&#xD;
CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>World Health Organization Brief Quality of Life Scale</title>
          <description>The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale</description>
          <population>Analysis for QOL data comparing pre- and post intervention scores</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="O2" value="2" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>World Health Organization Brief Quality of Life Scale</title>
        <description>The WHOQOL-Bref will assess quality of life in patients and carers. The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale</description>
        <time_frame>Immediately post-intervention</time_frame>
        <population>Groups attending CST sessions</population>
        <group_list>
          <group group_id="O1">
            <title>CST Intervention</title>
            <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.&#xD;
CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>World Health Organization Brief Quality of Life Scale</title>
          <description>The WHOQOL-Bref will assess quality of life in patients and carers. The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale</description>
          <population>Groups attending CST sessions</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="2.5" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>World Health Organization Brief Quality of Life Scale</title>
        <description>The scale will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale.</description>
        <time_frame>Four weeks post intervention</time_frame>
        <population>people atending CST sessions</population>
        <group_list>
          <group group_id="O1">
            <title>CST Intervention</title>
            <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.&#xD;
CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>World Health Organization Brief Quality of Life Scale</title>
          <description>The scale will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale.</description>
          <population>people atending CST sessions</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="2.5" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Identification and Intervention for Elderly Africans Cognitive Screen</title>
        <description>The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.</description>
        <time_frame>Baseline</time_frame>
        <population>people attending CST</population>
        <group_list>
          <group group_id="O1">
            <title>CST Intervention</title>
            <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Identification and Intervention for Elderly Africans Cognitive Screen</title>
          <description>The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.</description>
          <population>people attending CST</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="4.25" upper_limit="8"/>
                    <measurement group_id="O2" value="5" lower_limit="3.75" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adapted Alzheimer's Disease Assessment Scale-cognitive Scale</title>
        <description>The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.</description>
        <time_frame>Baseline</time_frame>
        <population>people attending CST</population>
        <group_list>
          <group group_id="O1">
            <title>CST Intervention</title>
            <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.&#xD;
CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Adapted Alzheimer's Disease Assessment Scale-cognitive Scale</title>
          <description>The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.</description>
          <population>people attending CST</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.5" spread="8.358"/>
                    <measurement group_id="O2" value="27.4" spread="6.647"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Anxiety and Depression Scale</title>
        <description>The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.</description>
        <time_frame>Baseline</time_frame>
        <population>People attending CST</population>
        <group_list>
          <group group_id="O1">
            <title>CST Intervention</title>
            <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.&#xD;
CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety and Depression Scale</title>
          <description>The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.</description>
          <population>People attending CST</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="4.5" upper_limit="12.75"/>
                    <measurement group_id="O2" value="5.5" lower_limit="3.75" upper_limit="11.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Zarit Burden Interview</title>
        <description>The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.</description>
        <time_frame>Baseline</time_frame>
        <population>People attending CST</population>
        <group_list>
          <group group_id="O1">
            <title>CST Intervention</title>
            <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.&#xD;
CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Zarit Burden Interview</title>
          <description>The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.</description>
          <population>People attending CST</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="10.25" upper_limit="20.75"/>
                    <measurement group_id="O2" value="17.5" lower_limit="10.75" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Identification and Intervention for Elderly Africans Cognitive Screen</title>
        <description>The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.</description>
        <time_frame>Immediately post-intervention</time_frame>
        <population>People attending CST</population>
        <group_list>
          <group group_id="O1">
            <title>CST Intervention</title>
            <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.&#xD;
CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Identification and Intervention for Elderly Africans Cognitive Screen</title>
          <description>The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.</description>
          <population>People attending CST</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="4" upper_limit="8"/>
                    <measurement group_id="O2" value="6.5" lower_limit="4.75" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adapted Alzheimer's Disease Assessment Scale-cognitive Scale</title>
        <description>The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.</description>
        <time_frame>Immediately post-intervention</time_frame>
        <population>People attending CST</population>
        <group_list>
          <group group_id="O1">
            <title>CST Intervention</title>
            <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.&#xD;
CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Adapted Alzheimer's Disease Assessment Scale-cognitive Scale</title>
          <description>The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.</description>
          <population>People attending CST</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.4" spread="8.560"/>
                    <measurement group_id="O2" value="26.6" spread="7.121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Anxiety and Depression Scale</title>
        <description>The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.</description>
        <time_frame>Immediately post-intervention</time_frame>
        <population>People attending CST</population>
        <group_list>
          <group group_id="O1">
            <title>CST Intervention</title>
            <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.&#xD;
CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety and Depression Scale</title>
          <description>The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.</description>
          <population>People attending CST</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" lower_limit="8.0" upper_limit="13.0"/>
                    <measurement group_id="O2" value="7.5" lower_limit="3.5" upper_limit="11.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Zarit Burden Interview</title>
        <description>The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.</description>
        <time_frame>Immediately post-intervention</time_frame>
        <population>people attending CST</population>
        <group_list>
          <group group_id="O1">
            <title>CST Intervention</title>
            <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.&#xD;
CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Zarit Burden Interview</title>
          <description>The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.</description>
          <population>people attending CST</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" lower_limit="5.75" upper_limit="16.75"/>
                    <measurement group_id="O2" value="13.0" lower_limit="9.5" upper_limit="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>CST Intervention</title>
          <description>We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.&#xD;
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.&#xD;
CST Intervention: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life.</description>
        </group>
        <group group_id="E2">
          <title>Group 2</title>
          <description>and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Professor Richard Walker</name_or_title>
      <organization>Northumbria Healthcare NHS Foundation Trust</organization>
      <phone>+441912932709</phone>
      <email>richard.walker@nhct.nhs.uk</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02229474
org study id: IDEA_TANZANIA_CST1
nct id: NCT02229474
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This trials of cognitive stimulation therapy (CST) in Tanzania is part of the larger
      Identification and Intervention for Dementia in Elderly Africans (IDEA) study.

      The overall aim of the IDEA study is to set up and evaluate sustainable programmes to
      facilitate diagnosis of, and therapy for, people with dementia led by local communities in
      sub-Saharan Africa. We aim seek to improve quality of life for people with dementia and their
      caregivers.

      Within this trial of CST, we hypothesise that CST can significantly improve the quality of
      people with dementia and their carers living in Africa
Our project will address three specific challenges: 1) Integrate screening and core packages
      of services into routine primary health care. 2) Provide effective and affordable
      community-based care and rehabilitation. 3) Develop effective treatment for use by
      non-specialists, including lay healthcare workers with minimal training.

      Dementia is under-diagnosed in sub-Saharan Africa (SSA) and treatment is rarely accessed or
      available. The burden of dementia on caregivers is high, with loss of income, and
      psychosocial stress common. However, large scale screening for dementia in such a setting is
      neither affordable nor sustainable. The purpose of this 3 year project is to provide a
      sustainable mechanism for diagnosis and therapeutic intervention for people with dementia. We
      will use 2 complimentary, rural study sites, 1 in Nigeria, West Africa and 2 in Tanzania,
      East Africa. As a consequence our results should be generalizable to all SSA. Our approach is
      inexpensive and will have applicability to other low- and middle-income countries.

      During Phase I we will validate a screening tool, previously developed by members of our
      study team from data collected in Tanzania, and carry out a pilot study of the benefits of
      cognitive stimulation therapy (CST) when used in SSA for those already identified with
      dementia. During both of these activities we will initiate training of local healthcare
      workers in diagnosis and management of people with dementia. In Phase II we will engage with
      local communities to raise awareness of dementia. Building on previous work at both study
      sites, we will initiate poster, newspaper and radio advertising and use mobile phone text
      messaging services (for relevant healthcare personnel) to increase awareness of the need to
      diagnose and intervene at an early stage. We will empower local private pharmacies to help
      identify people with dementia, a relationship which will ultimately be mutually beneficial
      through the supply of medicines to treat risk factors for dementia, such as hypertension. We
      will engage with local community leaders and government officials to assist us in this
      awareness raising, an approach that has proven successful in previous studies by our team in
      SSA. One of our study team (Dr Mushi (DM)) is a social scientist based in Tanzania and during
      Phase II we will conduct qualitative research into attitudes and beliefs surrounding dementia
      and identify any barriers to diagnosis in both sites. The results of this research will be
      fed back to inform other phases of the study. Finally, in phase III we will initiate a
      program of community based CST led by local occupational therapists (OTs) and nurse
      specialists. OTs and nurses will train caregivers in CST techniques and we hope that the
      training will ultimately be led by caregivers allowing such therapy to become sustainable
      within communities in the longer term. We will evaluate changes in cognition in people with
      dementia, and quality of life (QOL) in both people with dementia and their caregivers,
      post-intervention. We will carry out a full economic evaluation of the effect of our program,
      to be led by a heath economist based at Newcastle University, United Kingdom.

      This protocol cover the CST trial (Phase III of the study) in Tanzania
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: World Health Organization Brief Quality of Life Scale
time frame: Baseline
description: The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale
measure: World Health Organization Brief Quality of Life Scale
time frame: Immediately post-intervention
description: The WHOQOL-Bref will assess quality of life in patients and carers. The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale
measure: World Health Organization Brief Quality of Life Scale
time frame: Four weeks post intervention
description: The scale will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale.
measure: Identification and Intervention for Elderly Africans Cognitive Screen
time frame: Baseline
description: The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.
measure: Adapted Alzheimer's Disease Assessment Scale-cognitive Scale
time frame: Baseline
description: The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.
measure: Hospital Anxiety and Depression Scale
time frame: Baseline
description: The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.
measure: Zarit Burden Interview
time frame: Baseline
description: The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.
measure: Identification and Intervention for Elderly Africans Cognitive Screen
time frame: Immediately post-intervention
description: The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.
measure: Adapted Alzheimer's Disease Assessment Scale-cognitive Scale
time frame: Immediately post-intervention
description: The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.
measure: Hospital Anxiety and Depression Scale
time frame: Immediately post-intervention
description: The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.
measure: Zarit Burden Interview
time frame: Immediately post-intervention
description: The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.
arm group label: CST intervention
arm group type: Experimental
description: We will use a two-group stepped-wedge design. Group 1 will receive the intervention immediately. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
In accordance with the CST manual protocol, patients will be allocated to groups to ensure a spread of abilities and ensure inclusivity. No group contains only one individual of a particular religion or gender, such that they may feel left out. We will allocate patients to groups to avoid excessive travel to the group meeting place, participants may be allocated to a group based on their geographical location.
arm group label: Group 2
arm group type: No Intervention
description: and group 2 will have their intervention delayed until after the end of the group 1 intervention. This will also allow group 2 to act as controls for group 1 and allow further analysis as a controlled trial, during secondary analysis.
intervention type: Behavioral
intervention name: CST Intervention
description: The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life. Sessions will be led and facilitated by a study nurse or occupational therapist. The sessions will be held at a local health centre of village hall.
arm group label: CST intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Adesola Ogunniyi, MD
role: Principal Investigator
affiliation: University of Ibadan, Ibadan, Nigeria
last name: Richard W Walker, MD
role: Study Chair
affiliation: Northumbra Healthcare NHS Foundation Trust
last name: Delare Mushi
role: Study Director
affiliation: Kilimanjaro Christian Medical University College
last name: Catherine L Dotchin, MD
role: Study Director
affiliation: Northumbria Healthcare NHS Foundation Trust
last name: William K Gray, PhD
role: Study Director
affiliation: Northumbria Healthcare NHS Foundaion Trust
facility: 
country: Tanzania
citation: Longdon AR, Paddick SM, Kisoli A, Dotchin C, Gray WK, Dewhurst F, Chaote P, Teodorczuk A, Dewhurst M, Jusabani AM, Walker R. The prevalence of dementia in rural Tanzania: a cross-sectional community-based study. Int J Geriatr Psychiatry. 2013 Jul;28(7):728-37. doi: 10.1002/gps.3880. Epub 2012 Sep 20.
PMID: 22996739
citation: Gray WK, Paddick SM, Kisoli A, Dotchin CL, Longdon AR, Chaote P, Samuel M, Jusabani AM, Walker RW. Development and Validation of the Identification and Intervention for Dementia in Elderly Africans (IDEA) Study Dementia Screening Instrument. J Geriatr Psychiatry Neurol. 2014 Jun;27(2):110-8. doi: 10.1177/0891988714522695. Epub 2014 Feb 26.
PMID: 24578459
responsible party type: Sponsor-Investigator
investigator affiliation: Northumbria Healthcare NHS Foundation Trust
investigator full name: William Keith Gray
investigator title: Dr William Gray
mesh term: Dementia
sharing ipd: Yes
ipd description: We will publish our findings in academic journals and state that we will make anonymized participant level data available in the manuscript, upon request to the authors.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 