<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/NCT02233530</url>
  </required_header>
  <id_info>
    <org_study_id>IDEA_NIGERIA_CST1</org_study_id>
    <nct_id>NCT02233530</nct_id>
  </id_info>
  <brief_title>IDEA Study Cognitive Stimulation Therapy (CST) Trial in Nigeria</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. The investigators seek to improve quality of life for people with&#xD;
      dementia and their caregivers.&#xD;
&#xD;
      Within this trial of CST, the investigators hypothesise that CST can significantly improve&#xD;
      the quality of people with dementia and their carers living in Africa&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The 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.&#xD;
      The investigators will use 2 complimentary, rural study sites, 1 in Nigeria, West Africa and&#xD;
      2 in Tanzania, East Africa. As a consequence our results should be generalizable to all SSA.&#xD;
      Our approach is inexpensive and will have applicability to other low- and middle-income&#xD;
      countries.&#xD;
&#xD;
      During Phase I the investigators will validate a screening tool, previously developed by&#xD;
      members of our study team from data collected in Tanzania, and carry out a pilot study of the&#xD;
      benefits of cognitive stimulation therapy (CST) when used in SSA for those already identified&#xD;
      with dementia. During both of these activities the investigators will initiate training of&#xD;
      local healthcare workers in diagnosis and management of people with dementia. In Phase II the&#xD;
      investigators will engage with local communities to raise awareness of dementia. Building on&#xD;
      previous work at both study sites, the investigators will initiate poster, newspaper and&#xD;
      radio advertising and use mobile phone text messaging services (for relevant healthcare&#xD;
      personnel) to increase awareness of the need to diagnose and intervene at an early stage. The&#xD;
      investigators will empower local private pharmacies to help identify people with dementia, a&#xD;
      relationship which will ultimately be mutually beneficial through the supply of medicines to&#xD;
      treat risk factors for dementia, such as hypertension. The investigators will engage with&#xD;
      local community leaders and government officials to assist us in this awareness raising, an&#xD;
      approach that has proven successful in previous studies by our team in SSA. One of our study&#xD;
      team (Dr Mushi (DM)) is a social scientist based in Tanzania and during Phase II the&#xD;
      investigators will conduct qualitative research into attitudes and beliefs surrounding&#xD;
      dementia and identify any barriers to diagnosis in both sites. The results of this research&#xD;
      will be fed back to inform other phases of the study. Finally, in phase III the investigators&#xD;
      will initiate a program of community based CST led by local occupational therapists (OTs) and&#xD;
      nurse specialists. OTs and nurses will train caregivers in CST techniques and the&#xD;
      investigators hope that the training will ultimately be led by caregivers allowing such&#xD;
      therapy to become sustainable within communities in the longer term. The investigators will&#xD;
      evaluate changes in cognition in people with dementia, and quality of life (QOL) in both&#xD;
      people with dementia and their caregivers, post-intervention. The investigators will carry&#xD;
      out a full economic evaluation of the effect of our program, to be led by a heath economist&#xD;
      based at Newcastle University, United Kingdom.&#xD;
&#xD;
      This protocol cover the CST trial (Phase III of the study) in Nigeria&#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">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)</measure>
    <time_frame>Baseline</time_frame>
    <description>Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)</measure>
    <time_frame>An average of eight weeks from baseline</time_frame>
    <description>Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>WHOQOL Bref</measure>
    <time_frame>An average of twelve weeks from baseline</time_frame>
    <description>Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IDEA Cognitive Screen</measure>
    <time_frame>Baseline</time_frame>
    <description>Cognitive assessment in patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IDEA Cognitive Screen</measure>
    <time_frame>An average of eight weeks from baseline</time_frame>
    <description>Cognitive assessment in patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IDEA Cognitive Screen</measure>
    <time_frame>An average of twelve weeks from baseline</time_frame>
    <description>Cognitive assessment in patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Anxiety and depression assessment in patients and carers. The minimum score is 0 and the maximum 42, with a higher score signifying greater depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>An average of eight weeks from baseline</time_frame>
    <description>Anxiety and depression assessment in patients and carers. The minimum score is 0 and the maximum 42, with a higher score signifying greater depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>An average of twelve weeks from baseline</time_frame>
    <description>Anxiety and depression assessment in patients and carers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Burden Interview (ZBI)</measure>
    <time_frame>Baseline</time_frame>
    <description>Carer burden assessment. The minimum score is 0 and the maximum 48, with a higher score signifying greater carer burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Burden Interview (ZBI)</measure>
    <time_frame>An average of eight weeks from baseline</time_frame>
    <description>Carer burden assessment. The minimum score is 0 and the maximum 48, with a higher score signifying greater carer burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Burden Interview (ZBI)</measure>
    <time_frame>An average of twelve weeks from baseline</time_frame>
    <description>Carer burden assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)</measure>
    <time_frame>Baseline</time_frame>
    <description>Cognitive assessment in patients. The minimum score is 0 and the maximum 70, with a lower score signifying better cognition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)</measure>
    <time_frame>An average of eight weeks from baseline</time_frame>
    <description>Cognitive assessment in patients. The minimum score is 0 and the maximum 70, with a lower score signifying better cognition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)</measure>
    <time_frame>An average of twelve weeks from baseline</time_frame>
    <description>Cognitive assessment in patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study Specific Economic Evaluation</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessment of health service utilisation and time and travel for patients and carers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study Specific Economic Evaluation</measure>
    <time_frame>An average of twelve weeks from baseline</time_frame>
    <description>Assessment of health service utilisation and time and travel for patients and carers</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>CST intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Outcomes at baseline will be compared with those immediately post intervention and at four weeks post-intervention.&#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. The investigators 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. Individuals will be allocated to groups based on religion, gender and geographical location.</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, Nigeria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Akin Adebiyi</last_name>
    <role>Study Director</role>
    <affiliation>University of Ibadan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lalupon</name>
      <address>
        <city>Lalupon</city>
        <state>Oyo State</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <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>May 2021</verification_date>
  <study_first_submitted>August 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <results_first_submitted>March 10, 2021</results_first_submitted>
  <results_first_submitted_qc>May 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 21, 2021</results_first_posted>
  <last_update_submitted>May 26, 2021</last_update_submitted>
  <last_update_submitted_qc>May 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2021</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 Willliam 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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CST Intervention</title>
          <description>Outcomes at baseline will be compared with those immediately post intervention and at four weeks post-intervention.&#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. The investigators 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. Individuals will be allocated to groups based on religion, gender and 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. 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_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Cognitive stimulation therapy participants. Participant received two sessions per week for seven weeks, with 14 sessions in total. Each session lasted between 45 and 60 minutes.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age was recorded in years</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="79" upper_limit="90"/>
                  </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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Nigeria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </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 Measure (WHOQOL-Bref)</title>
        <description>Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.</description>
        <time_frame>Baseline</time_frame>
        <population>All baseline participants</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention group</description>
          </group>
        </group_list>
        <measure>
          <title>World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)</title>
          <description>Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.</description>
          <population>All baseline participants</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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" lower_limit="9.4" upper_limit="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)</title>
        <description>Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.</description>
        <time_frame>An average of eight weeks from baseline</time_frame>
        <population>All baseline participants</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention group</description>
          </group>
        </group_list>
        <measure>
          <title>World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)</title>
          <description>Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.</description>
          <population>All baseline participants</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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" lower_limit="12.3" upper_limit="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>WHOQOL Bref</title>
        <description>Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.</description>
        <time_frame>An average of twelve weeks from baseline</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IDEA Cognitive Screen</title>
        <description>Cognitive assessment in patients</description>
        <time_frame>Baseline</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IDEA Cognitive Screen</title>
        <description>Cognitive assessment in patients</description>
        <time_frame>An average of eight weeks from baseline</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IDEA Cognitive Screen</title>
        <description>Cognitive assessment in patients</description>
        <time_frame>An average of twelve weeks from baseline</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Anxiety and Depression Scale (HADS)</title>
        <description>Anxiety and depression assessment in patients and carers. The minimum score is 0 and the maximum 42, with a higher score signifying greater depression.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention group</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety and Depression Scale (HADS)</title>
          <description>Anxiety and depression assessment in patients and carers. The minimum score is 0 and the maximum 42, with a higher score signifying greater depression.</description>
          <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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" lower_limit="19" upper_limit="21.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Anxiety and Depression Scale (HADS)</title>
        <description>Anxiety and depression assessment in patients and carers. The minimum score is 0 and the maximum 42, with a higher score signifying greater depression.</description>
        <time_frame>An average of eight weeks from baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention group</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety and Depression Scale (HADS)</title>
          <description>Anxiety and depression assessment in patients and carers. The minimum score is 0 and the maximum 42, with a higher score signifying greater depression.</description>
          <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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" lower_limit="18.5" upper_limit="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Anxiety and Depression Scale (HADS)</title>
        <description>Anxiety and depression assessment in patients and carers</description>
        <time_frame>An average of twelve weeks from baseline</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Zarit Burden Interview (ZBI)</title>
        <description>Carer burden assessment. The minimum score is 0 and the maximum 48, with a higher score signifying greater carer burden.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention group</description>
          </group>
        </group_list>
        <measure>
          <title>Zarit Burden Interview (ZBI)</title>
          <description>Carer burden assessment. The minimum score is 0 and the maximum 48, with a higher score signifying greater carer burden.</description>
          <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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" lower_limit="10" upper_limit="35.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Zarit Burden Interview (ZBI)</title>
        <description>Carer burden assessment. The minimum score is 0 and the maximum 48, with a higher score signifying greater carer burden.</description>
        <time_frame>An average of eight weeks from baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention group</description>
          </group>
        </group_list>
        <measure>
          <title>Zarit Burden Interview (ZBI)</title>
          <description>Carer burden assessment. The minimum score is 0 and the maximum 48, with a higher score signifying greater carer burden.</description>
          <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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="7.5" upper_limit="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Zarit Burden Interview (ZBI)</title>
        <description>Carer burden assessment</description>
        <time_frame>An average of twelve weeks from baseline</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)</title>
        <description>Cognitive assessment in patients. The minimum score is 0 and the maximum 70, with a lower score signifying better cognition.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention group</description>
          </group>
        </group_list>
        <measure>
          <title>Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)</title>
          <description>Cognitive assessment in patients. The minimum score is 0 and the maximum 70, with a lower score signifying better cognition.</description>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="5.5" upper_limit="35.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)</title>
        <description>Cognitive assessment in patients. The minimum score is 0 and the maximum 70, with a lower score signifying better cognition.</description>
        <time_frame>An average of eight weeks from baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Intervention group</description>
          </group>
        </group_list>
        <measure>
          <title>Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)</title>
          <description>Cognitive assessment in patients. The minimum score is 0 and the maximum 70, with a lower score signifying better cognition.</description>
          <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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="3.5" upper_limit="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)</title>
        <description>Cognitive assessment in patients</description>
        <time_frame>An average of twelve weeks from baseline</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Study Specific Economic Evaluation</title>
        <description>Assessment of health service utilisation and time and travel for patients and carers</description>
        <time_frame>Baseline</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Study Specific Economic Evaluation</title>
        <description>Assessment of health service utilisation and time and travel for patients and carers</description>
        <time_frame>An average of twelve weeks from baseline</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the intervention</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Intervention group</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </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="9"/>
              </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>Dr Adesola Ogunniyi</name_or_title>
      <organization>University of Ibadan, Ibadan, Nigeria</organization>
      <phone>+2348038094173</phone>
      <email>aogunniyi892@gmail.com</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/NCT02233530
org study id: IDEA_NIGERIA_CST1
nct id: NCT02233530
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. The investigators seek to improve quality of life for people with
      dementia and their caregivers.

      Within this trial of CST, the investigators hypothesise that CST can significantly improve
      the quality of people with dementia and their carers living in Africa
The 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.
      The investigators 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 the investigators 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 the investigators will initiate training of
      local healthcare workers in diagnosis and management of people with dementia. In Phase II the
      investigators will engage with local communities to raise awareness of dementia. Building on
      previous work at both study sites, the investigators 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. The
      investigators 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. The investigators 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 the
      investigators 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 the investigators
      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 the
      investigators hope that the training will ultimately be led by caregivers allowing such
      therapy to become sustainable within communities in the longer term. The investigators will
      evaluate changes in cognition in people with dementia, and quality of life (QOL) in both
      people with dementia and their caregivers, post-intervention. The investigators 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 Nigeria
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)
time frame: Baseline
description: Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.
measure: World Health Organization Brief Quality of Life Measure (WHOQOL-Bref)
time frame: An average of eight weeks from baseline
description: Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.
measure: WHOQOL Bref
time frame: An average of twelve weeks from baseline
description: Quality of life assessment in patients and carers. The minimum score is 4 and the maximum 20, with a higher score signifying better quality of life.
measure: IDEA Cognitive Screen
time frame: Baseline
description: Cognitive assessment in patients
measure: IDEA Cognitive Screen
time frame: An average of eight weeks from baseline
description: Cognitive assessment in patients
measure: IDEA Cognitive Screen
time frame: An average of twelve weeks from baseline
description: Cognitive assessment in patients
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: Baseline
description: Anxiety and depression assessment in patients and carers. The minimum score is 0 and the maximum 42, with a higher score signifying greater depression.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: An average of eight weeks from baseline
description: Anxiety and depression assessment in patients and carers. The minimum score is 0 and the maximum 42, with a higher score signifying greater depression.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: An average of twelve weeks from baseline
description: Anxiety and depression assessment in patients and carers
measure: Zarit Burden Interview (ZBI)
time frame: Baseline
description: Carer burden assessment. The minimum score is 0 and the maximum 48, with a higher score signifying greater carer burden.
measure: Zarit Burden Interview (ZBI)
time frame: An average of eight weeks from baseline
description: Carer burden assessment. The minimum score is 0 and the maximum 48, with a higher score signifying greater carer burden.
measure: Zarit Burden Interview (ZBI)
time frame: An average of twelve weeks from baseline
description: Carer burden assessment
measure: Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)
time frame: Baseline
description: Cognitive assessment in patients. The minimum score is 0 and the maximum 70, with a lower score signifying better cognition.
measure: Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)
time frame: An average of eight weeks from baseline
description: Cognitive assessment in patients. The minimum score is 0 and the maximum 70, with a lower score signifying better cognition.
measure: Adapted Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)
time frame: An average of twelve weeks from baseline
description: Cognitive assessment in patients
measure: Study Specific Economic Evaluation
time frame: Baseline
description: Assessment of health service utilisation and time and travel for patients and carers
measure: Study Specific Economic Evaluation
time frame: An average of twelve weeks from baseline
description: Assessment of health service utilisation and time and travel for patients and carers
arm group label: CST intervention
arm group type: Experimental
description: Outcomes at baseline will be compared with those immediately post intervention and at four weeks post-intervention.
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. The investigators 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. Individuals will be allocated to groups based on religion, gender and geographical location.
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, Nigeria
last name: Akin Adebiyi
role: Study Director
affiliation: University of Ibadan
facility: 
country: Nigeria
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 Willliam Gray
mesh term: Dementia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 