<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/NCT03282877</url>
  </required_header>
  <id_info>
    <org_study_id>iCST web-application</org_study_id>
    <nct_id>NCT03282877</nct_id>
  </id_info>
  <brief_title>iCST Web-application for People With Dementia</brief_title>
  <official_title>Adapting Individual Cognitive Stimulation Therapy (iCST) for Delivery by a Web-application</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the UK, over 670,000 older people are living with dementia which has a substantial,&#xD;
      multi-level impact on society, the person with dementia, and their carers. There is a need&#xD;
      for an increase in the availability of psychological therapies since people with dementia can&#xD;
      face difficulties with staying mentally stimulated and engaged. Cognitive Stimulation Therapy&#xD;
      (CST) offers a person based approach and can help to relieve some of these problems. It is a&#xD;
      brief manualised evidence based psychological treatment for people with mild to moderate&#xD;
      dementia which has shown to improve cognition and quality of life. CST is currently available&#xD;
      in both a group and individualised format called iCST. It is worthwhile to explore a&#xD;
      computerised version of iCST since it would take together the added value of computer use and&#xD;
      the beneficial effects of iCST which might produce combined, positive effects on cognition&#xD;
      and quality of life. The investigators have spoken to people with dementia and their carers&#xD;
      who are keen on using technology to stay mentally active and stimulated. This study sets out&#xD;
      to develop and evaluate the potential benefits of an iCST web-application within a&#xD;
      feasibility study. The effects on cognition and quality of life between (a) usual care and&#xD;
      (b) iCST web-application over 11 weeks will be compared. A web-application is a website which&#xD;
      can easily be accessed on and is compatible with computers and tablets. In order to create&#xD;
      the most appropriate and practical web-application, the research team will work closely&#xD;
      together with people with dementia, their carers, and the software company. An iCST&#xD;
      web-application will compliment traditional CST by making it even more accessible since&#xD;
      technology users will be able to access it easily on their device. Furthermore, a&#xD;
      computerised version of iCST will by highly relevant for upcoming generations who have grown&#xD;
      up with the use of technology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scientific justification:&#xD;
&#xD;
      Since the use of technology is rapidly increasing in every aspect of many people's daily&#xD;
      lives, previous research has already begun to investigate its application and implementation&#xD;
      in multiple areas within dementia care. An example of an area where technology and dementia&#xD;
      come together is computerised cognitive interventions. These types of interventions build on&#xD;
      the added benefits of computer use such as reduced cognitive decline in older adults and&#xD;
      lower risk of receiving a diagnosis of dementia among older men with the added benefits of&#xD;
      using one's cognitive capacities. In a recent systematic review, Garcia-Casal et al. (2016)&#xD;
      concluded that computerised cognitive interventions led to significant improvements in&#xD;
      cognition, depression and anxiety among people with dementia. Computerised cognitive&#xD;
      interventions may have more of an impact on cognition than non-computerised cognitive&#xD;
      interventions.&#xD;
&#xD;
      In a randomised pilot trial conducted by Tárraga et al. (2006) which was included in&#xD;
      Garcia-Casal's review, people with mild Alzheimer's Disease were allocated to a treatment&#xD;
      group and a control group. The treatment group consisted of both a computerised cognitive&#xD;
      stimulation programme and a non-computerised, face-to-face cognitive stimulation programme&#xD;
      delivered in groups. The control group consisted solely of the non-computerised, cognitive&#xD;
      stimulation programme. The results showed that that people with mild Alzheimer's Disease&#xD;
      showed greater improvements in cognition lasting for 24 weeks in the treatment group which&#xD;
      suggests added benefits of a computerised cognitive stimulation programme.&#xD;
&#xD;
      These positive findings suggest that it is worthwhile to continue conducting research in the&#xD;
      area of computerised cognitive interventions. Interestingly, Garcia-Casal et al (2016) have&#xD;
      pointed out that the area of computerised cognitive stimulation (which is an area of&#xD;
      computerised cognitive interventions) is relatively underdeveloped. Most computerised&#xD;
      cognitive interventions are geared towards cognitive training.&#xD;
&#xD;
      At the moment there are multiple, paper-based cognitive stimulation interventions available&#xD;
      of which Cognitive Stimulation Therapy is being used more predominantly in the UK. CST is a&#xD;
      brief evidence-based psychological treatment for people with mild to moderate dementia. It&#xD;
      consists of mentally stimulating and engaging group activities which have shown to improve&#xD;
      cognition and quality of life in a large scale randomised controlled trial. More recently, an&#xD;
      individualised version of CST (iCST) was developed which is a home-based version of CST&#xD;
      administered by informal carers (e.g., friends, family members). The content of the sessions&#xD;
      is similar to those of CST. A multi-centre RCT of iCST showed no improvements in cognition&#xD;
      and QoL for people with dementia, nor evidence of improvements in carers' mental and physical&#xD;
      health. However, people with dementia receiving iCST reported a better relationship quality&#xD;
      with their carer, and carers reported an improved health-related QoL. These findings indicate&#xD;
      a need for further research to determine the effectiveness of carer-led cognitive stimulation&#xD;
      interventions for people with dementia since most people received fewer than recommended&#xD;
      number of iCST due to low adherence.&#xD;
&#xD;
      Since there is a need for more research in both the area of computerised cognitive&#xD;
      stimulation and carer-led cognitive stimulation, this research sets out to develop and&#xD;
      evaluate the potential benefits of iCST adapted for delivery by an interactive (touch-screen)&#xD;
      web-application in a feasibility study. The investigators are setting out to combine the&#xD;
      added value of computer use and the beneficial effects of CST/iCST in order to produce&#xD;
      benefits in cognition and quality of life. A participatory process while developing the&#xD;
      web-application in the form of consultations, focus groups and interviews will be employed.&#xD;
      Preliminary consultations with people with dementia and their carers have already given the&#xD;
      investigators information on attitudes towards (touch-screen) technology, both appealing and&#xD;
      non-appealing features of applications and desired length/duration of iCST.&#xD;
&#xD;
      The investigators hope to see signs of improvements in quality of life and cognition after&#xD;
      using the iCST web-application. If this is the case, this could lead to a larger randomised&#xD;
      controlled trial with more participants to formally establish effectiveness. An iCST&#xD;
      web-application has the potential to be more accessible for people on a national and an&#xD;
      international level when adapted to appropriate cultural contexts compared to paper-based&#xD;
      manuals. Lastly, the iCST web-application could be used long-term and could rapidly become&#xD;
      widely used as a clinically and cost-effective standardised, and feasible intervention.&#xD;
&#xD;
      Design and methodology:&#xD;
&#xD;
        1. The focus groups and interviews will be a multi-centre study to gain insights and&#xD;
           perspectives from people with dementia and their carers regarding the usability of the&#xD;
           iCST web-app. This will enable the investigators to optimise the developmental process&#xD;
           and learn about the experiences of the participants while they interact with the&#xD;
           web-application. Observational and transcribed audio-recorded data will be collected&#xD;
           from the focus groups and interviews which will be semi-structured in nature.&#xD;
&#xD;
        2. The feasibility study will be a multicentre, pragmatic, single blind, randomised 2&#xD;
           treatment arm (iCST web-app vs treatment as usual) study over 11 weeks.&#xD;
&#xD;
      In accordance with good research practice, the investigators have decided to run a&#xD;
      feasibility study prior to running a larger randomised controlled trial in order to assess&#xD;
      the usability of the iCST web-application and the feasibility of running a larger-scale&#xD;
      randomised clinical trial. With this feasibility study the investigators will be able to gain&#xD;
      insights with regard to recruitment/drop-out rates, adherence, sample size, appropriateness&#xD;
      of outcome measures, changes to made to the web-application etc. This will all be necessary&#xD;
      information before a larger trial can be conducted.&#xD;
&#xD;
      Programme development:&#xD;
&#xD;
      The iCST web-application will be adapted from the paper-based iCST manual. The amount of&#xD;
      sessions will be reduced from 75 to 21 after consultations with people with dementia and&#xD;
      carers pointed out that the paper-based iCST manual contained too many sessions. Multimedia&#xD;
      within the web-application will be used and participants will be given the opportunity to&#xD;
      provide ongoing feedback on the web-application itself after completing each session. The&#xD;
      research team will work together with all the stakeholders such as the software company&#xD;
      employed to build the web-application, the people with dementia, and their carers. Regular&#xD;
      consultations, focus groups and interviews should aid the development of the web-application&#xD;
      in ensuring it is feasible, practical and appealing.&#xD;
&#xD;
      Recruitment for the study:&#xD;
&#xD;
      Recruitment for the focus groups, interviews and feasibility study will take place in a&#xD;
      variety of community settings in Nottingham consisting of both primary care settings&#xD;
      (outpatient clinics) and secondary care settings (community mental health teams (CMHTs),&#xD;
      memory clinics, care homes, day centres, and voluntary sector organizations such as the&#xD;
      Alzheimer's Society). By including a variety of settings, the reach for people with dementia&#xD;
      and their carers will be extended. The PhD student will make close links with the&#xD;
      aforementioned services and organisations through attendance and regular contact. In&#xD;
      addition, the distribution of information leaflets and posters to organisations and&#xD;
      professionals involved in the identification of possible participants will facilitate the&#xD;
      recruitment process.&#xD;
&#xD;
      The initial approach will be from a member of the person with dementia's usual care team. If&#xD;
      the person with dementia and carer are willing and suitable for participation, the PhD&#xD;
      student will fully inform them about of all aspects pertaining to involvement in the study&#xD;
      through in person conversations and information leaflets. It will be explained to the&#xD;
      potential participant that; (i) entry into the study is entirely voluntary and that their&#xD;
      treatment and care will not be affected by their decision, (ii) they can withdraw at any time&#xD;
      but attempts will be made to avoid this occurrence and (iii) in the event of their withdrawal&#xD;
      their data collected so far cannot be erased and we will seek consent to use the data in the&#xD;
      final analyses where appropriate.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      The sample size estimation for the focus groups and interviews is based on previous work in&#xD;
      the iCST study. For the current study, four focus groups with six participants each (one with&#xD;
      people with dementia, one with carers, two collaborative groups) and ten interviews (five&#xD;
      with people with dementia and five with carers) will be conducted.&#xD;
&#xD;
      The investigators have estimated the sample size to be 60 participants. This is partly based&#xD;
      on previous work with iCST considering the numbers recruited and the amount of centres&#xD;
      involved in the iCST trial. The iCST trial recruited 356 participants over eight sites across&#xD;
      the UK (Bangor, Devon, Dorset, Hull, Lincolnshire, London, Manchester, Norfolk and Suffolk).&#xD;
      This equals to an average of 45 dyads per site. We will have an equal distribution of dyads&#xD;
      across the two groups leading to 30 dyads per arm (iCST web-application vs.&#xD;
      treatment-as-usual). The field-testing phase of iCST (without a control group) included 22&#xD;
      dyads which roughly resembles the sample size for the current feasibility study.&#xD;
&#xD;
      A sample size of 60 participants will be sufficient to demonstrate the effectiveness of the&#xD;
      iCST web-application with an effect size of 0.80 with 80% power and 5% significance&#xD;
      (two-tailed). The effect size has been chosen based on the sample size.&#xD;
&#xD;
      Timetable:&#xD;
&#xD;
      Focus groups/interviews (start from May 2018 onwards):&#xD;
&#xD;
        1. 3 months recruitment;&#xD;
&#xD;
        2. 4 months running of groups and interviews in Nottingham recruitment&#xD;
&#xD;
        3. 6 months analysis and writing up findings&#xD;
&#xD;
      Feasibility trial (start from November 2018 onwards):&#xD;
&#xD;
        1. 5 months of recruitment;&#xD;
&#xD;
        2. 7 months of running feasibility study;&#xD;
&#xD;
        3. 5 months analysis and writing up findings&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cognition (person with dementia)</measure>
    <time_frame>Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline</time_frame>
    <description>ADAS-Cog: to measure the severity of the cognitive symptoms (memory, language, praxis, attention and other cognitive abilities)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in quality of life (person with dementia)</measure>
    <time_frame>Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline</time_frame>
    <description>QoL-AD: self reporting questionnaire to investigate: physical health, energy, mood, living situation, memory, marriage, friends, chores, fun, money, self and life).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in general health outcome (carer)</measure>
    <time_frame>Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline</time_frame>
    <description>EQ-5D: An instrument used to measure health outcome, it provides a descriptive profile for health status. It evaluates quality of life in carers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression (person with dementia)</measure>
    <time_frame>Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline</time_frame>
    <description>CSDD: to measure depressive symptoms: mood-related signs, behavioural disturbances, physical signs, biological functions and ideational disturbances</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioural symptoms (person with dementia)</measure>
    <time_frame>Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline</time_frame>
    <description>NPI: to asses 10 behavioural disturbances: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy and aberrant motor activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities of daily living (person with dementia)</measure>
    <time_frame>Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline</time_frame>
    <description>BADLS: BADLS is an instrument consisting of 20 daily-living abilities (basic and instrumental activities)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between person with dementia and carer (both)</measure>
    <time_frame>Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline</time_frame>
    <description>QPCR: a measure of relationship quality which will be completed by both the person with dementia and the carer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression/anxiety (carer)</measure>
    <time_frame>Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline</time_frame>
    <description>HADS: is a useful measure anxiety and depression for carer. It consists of 14 questions (7 for anxiety and 7 for depression).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Computer use self efficacy</measure>
    <time_frame>Pre-intervention (baseline)</time_frame>
    <description>CUSE: will be used to assess self-efficacy beliefs in the context of computer/tablet use</description>
  </other_outcome>
  <other_outcome>
    <measure>System usability</measure>
    <time_frame>11 weeks post baseline</time_frame>
    <description>SUS: is a widely-used questionnaire measuring the usability of a technology-based tool e.g. a computer program or other device.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Mild Dementia</condition>
  <condition>Moderate Dementia</condition>
  <arm_group>
    <arm_group_label>iCST web-application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A computerised cognitive stimulation programme consisting of 21 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual (TAU)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will consist of a treatment-as-usual group and will not receive any additional intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>iCST web-application</intervention_name>
    <description>The iCST web-application will be delivered by a carer in regular contact with the person with dementia (family carer, a close friend, or a volunteer befriender) for 1.5 hours a week. It is up to the carer to distribute the time in a matter that is convenient to them (e.g. two long sessions of 45 minutes or 3 shorter sessions of 30 minutes). Participants will be asked to use the web-application for a duration of 11 weeks at their homes. Each session will consist of structured cognitive stimulation aided by the use of multimedia. After completing each session, participants will be guided to a new screen on the web-application in which they will be asked to briefly reflect on the session and provide us with feedback.</description>
    <arm_group_label>iCST web-application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Person with dementia:&#xD;
&#xD;
          -  Meet Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria for&#xD;
             dementia (American Psychiatric Association, 2013).&#xD;
&#xD;
          -  Score 10 or above on the Mini Mental State Examination (MMSE) (Folstein, Folstein, &amp;&#xD;
             McHugh, 1975) or score of 16 or above on the Montreal Cognitive Assessment (MoCA)&#xD;
             (Trzepacz et al., 2015) where available.&#xD;
&#xD;
          -  Some ability to communicate and understand (e.g. ability to give informed consent)&#xD;
&#xD;
          -  Ability to speak and understand English&#xD;
&#xD;
          -  See/hear well enough to participate&#xD;
&#xD;
          -  No major physical illness or disability affecting their participation&#xD;
&#xD;
          -  Age range: 50 years - no maximum age limit&#xD;
&#xD;
          -  Availability of a tablet to the person with dementia and carer&#xD;
&#xD;
          -  Availability of a carer (or friend/befriender) to participate in the focus groups,&#xD;
             interviews and iCST web-app sessions&#xD;
&#xD;
        Carer:&#xD;
&#xD;
          -  Minimum age: 21&#xD;
&#xD;
          -  Ability to speak and understand English&#xD;
&#xD;
          -  See/hear well enough to participate&#xD;
&#xD;
          -  No major physical illness or disability affecting their participation&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        Person with dementia and carer:&#xD;
&#xD;
        - Concurrent participation in any other interventional study for people with&#xD;
        dementia/carers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Orrell, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Justine Schneider, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Harleen Rai, MSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lauren Yates, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Derbyshire Healthcare NHS Foundation Trust</name>
      <address>
        <city>Derby</city>
        <state>Derbyshire</state>
        <zip>DE22 3LZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicestershire Partnership NHS Trust</name>
      <address>
        <city>Leicester</city>
        <state>Leicestershire</state>
        <zip>LE2 2PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lincolnshire Partnership NHS Foundation Trust</name>
      <address>
        <city>Lincoln</city>
        <state>Lincolnshire</state>
        <zip>LN1 1EJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottinghamshire Healthcare NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2TU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Xavier AJ, d'Orsi E, de Oliveira CM, Orrell M, Demakakos P, Biddulph JP, Marmot MG. English Longitudinal Study of Aging: can Internet/E-mail use reduce cognitive decline? J Gerontol A Biol Sci Med Sci. 2014 Sep;69(9):1117-21. doi: 10.1093/gerona/glu105.</citation>
    <PMID>25116923</PMID>
  </reference>
  <reference>
    <citation>Almeida OP, Yeap BB, Alfonso H, Hankey GJ, Flicker L, Norman PE. Older men who use computers have lower risk of dementia. PLoS One. 2012;7(8):e44239. doi: 10.1371/journal.pone.0044239. Epub 2012 Aug 28.</citation>
    <PMID>22937167</PMID>
  </reference>
  <reference>
    <citation>Garcia-Casal JA, Loizeau A, Csipke E, Franco-Martin M, Perea-Bartolome MV, Orrell M. Computer-based cognitive interventions for people living with dementia: a systematic literature review and meta-analysis. Aging Ment Health. 2017 May;21(5):454-467. doi: 10.1080/13607863.2015.1132677. Epub 2016 Jan 25.</citation>
    <PMID>26806365</PMID>
  </reference>
  <reference>
    <citation>Tarraga L, Boada M, Modinos G, Espinosa A, Diego S, Morera A, Guitart M, Balcells J, Lopez OL, Becker JT. A randomised pilot study to assess the efficacy of an interactive, multimedia tool of cognitive stimulation in Alzheimer's disease. J Neurol Neurosurg Psychiatry. 2006 Oct;77(10):1116-21. doi: 10.1136/jnnp.2005.086074. Epub 2006 Jul 4.</citation>
    <PMID>16820420</PMID>
  </reference>
  <reference>
    <citation>Hodge, S., Hailey, E &amp; Orrell, M. (eds) (2014). Memory Services National Accreditation Programme - Standards for Memory Services (4th Edition). London: Royal College of Psychiatrists.</citation>
  </reference>
  <reference>
    <citation>Spector, A., Thorgrimsen, L., Woods, B., &amp; Orrell, M. (2006). Making a difference. London: Hawker Publications.</citation>
  </reference>
  <reference>
    <citation>Spector A, Thorgrimsen L, Woods B, Royan L, Davies S, Butterworth M, Orrell M. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Br J Psychiatry. 2003 Sep;183:248-54. doi: 10.1192/bjp.183.3.248.</citation>
    <PMID>12948999</PMID>
  </reference>
  <reference>
    <citation>Orrell M, Yates L, Leung P, Kang S, Hoare Z, Whitaker C, Burns A, Knapp M, Leroi I, Moniz-Cook E, Pearson S, Simpson S, Spector A, Roberts S, Russell I, de Waal H, Woods RT, Orgeta V. The impact of individual Cognitive Stimulation Therapy (iCST) on cognition, quality of life, caregiver health, and family relationships in dementia: A randomised controlled trial. PLoS Med. 2017 Mar 28;14(3):e1002269. doi: 10.1371/journal.pmed.1002269. eCollection 2017 Mar.</citation>
    <PMID>28350796</PMID>
  </reference>
  <reference>
    <citation>Yates LA, Orrell M, Spector A, Orgeta V. Service users' involvement in the development of individual Cognitive Stimulation Therapy (iCST) for dementia: a qualitative study. BMC Geriatr. 2015 Feb 6;15:4. doi: 10.1186/s12877-015-0004-5.</citation>
    <PMID>25655940</PMID>
  </reference>
  <reference>
    <citation>Orrell M, Aguirre E, Spector A, Hoare Z, Woods RT, Streater A, Donovan H, Hoe J, Knapp M, Whitaker C, Russell I. Maintenance cognitive stimulation therapy for dementia: single-blind, multicentre, pragmatic randomised controlled trial. Br J Psychiatry. 2014 Jun;204(6):454-61. doi: 10.1192/bjp.bp.113.137414. Epub 2014 Mar 27.</citation>
    <PMID>24676963</PMID>
  </reference>
  <reference>
    <citation>Yates LA, Leung P, Orgeta V, Spector A, Orrell M. The development of individual cognitive stimulation therapy (iCST) for dementia. Clin Interv Aging. 2014 Dec 30;10:95-104. doi: 10.2147/CIA.S73844. eCollection 2015.</citation>
    <PMID>25565792</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>November 18, 2020</last_update_submitted>
  <last_update_submitted_qc>November 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03282877
org study id: iCST web-application
nct id: NCT03282877
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the UK, over 670,000 older people are living with dementia which has a substantial,
      multi-level impact on society, the person with dementia, and their carers. There is a need
      for an increase in the availability of psychological therapies since people with dementia can
      face difficulties with staying mentally stimulated and engaged. Cognitive Stimulation Therapy
      (CST) offers a person based approach and can help to relieve some of these problems. It is a
      brief manualised evidence based psychological treatment for people with mild to moderate
      dementia which has shown to improve cognition and quality of life. CST is currently available
      in both a group and individualised format called iCST. It is worthwhile to explore a
      computerised version of iCST since it would take together the added value of computer use and
      the beneficial effects of iCST which might produce combined, positive effects on cognition
      and quality of life. The investigators have spoken to people with dementia and their carers
      who are keen on using technology to stay mentally active and stimulated. This study sets out
      to develop and evaluate the potential benefits of an iCST web-application within a
      feasibility study. The effects on cognition and quality of life between (a) usual care and
      (b) iCST web-application over 11 weeks will be compared. A web-application is a website which
      can easily be accessed on and is compatible with computers and tablets. In order to create
      the most appropriate and practical web-application, the research team will work closely
      together with people with dementia, their carers, and the software company. An iCST
      web-application will compliment traditional CST by making it even more accessible since
      technology users will be able to access it easily on their device. Furthermore, a
      computerised version of iCST will by highly relevant for upcoming generations who have grown
      up with the use of technology.
Scientific justification:

      Since the use of technology is rapidly increasing in every aspect of many people's daily
      lives, previous research has already begun to investigate its application and implementation
      in multiple areas within dementia care. An example of an area where technology and dementia
      come together is computerised cognitive interventions. These types of interventions build on
      the added benefits of computer use such as reduced cognitive decline in older adults and
      lower risk of receiving a diagnosis of dementia among older men with the added benefits of
      using one's cognitive capacities. In a recent systematic review, Garcia-Casal et al. (2016)
      concluded that computerised cognitive interventions led to significant improvements in
      cognition, depression and anxiety among people with dementia. Computerised cognitive
      interventions may have more of an impact on cognition than non-computerised cognitive
      interventions.

      In a randomised pilot trial conducted by Tárraga et al. (2006) which was included in
      Garcia-Casal's review, people with mild Alzheimer's Disease were allocated to a treatment
      group and a control group. The treatment group consisted of both a computerised cognitive
      stimulation programme and a non-computerised, face-to-face cognitive stimulation programme
      delivered in groups. The control group consisted solely of the non-computerised, cognitive
      stimulation programme. The results showed that that people with mild Alzheimer's Disease
      showed greater improvements in cognition lasting for 24 weeks in the treatment group which
      suggests added benefits of a computerised cognitive stimulation programme.

      These positive findings suggest that it is worthwhile to continue conducting research in the
      area of computerised cognitive interventions. Interestingly, Garcia-Casal et al (2016) have
      pointed out that the area of computerised cognitive stimulation (which is an area of
      computerised cognitive interventions) is relatively underdeveloped. Most computerised
      cognitive interventions are geared towards cognitive training.

      At the moment there are multiple, paper-based cognitive stimulation interventions available
      of which Cognitive Stimulation Therapy is being used more predominantly in the UK. CST is a
      brief evidence-based psychological treatment for people with mild to moderate dementia. It
      consists of mentally stimulating and engaging group activities which have shown to improve
      cognition and quality of life in a large scale randomised controlled trial. More recently, an
      individualised version of CST (iCST) was developed which is a home-based version of CST
      administered by informal carers (e.g., friends, family members). The content of the sessions
      is similar to those of CST. A multi-centre RCT of iCST showed no improvements in cognition
      and QoL for people with dementia, nor evidence of improvements in carers' mental and physical
      health. However, people with dementia receiving iCST reported a better relationship quality
      with their carer, and carers reported an improved health-related QoL. These findings indicate
      a need for further research to determine the effectiveness of carer-led cognitive stimulation
      interventions for people with dementia since most people received fewer than recommended
      number of iCST due to low adherence.

      Since there is a need for more research in both the area of computerised cognitive
      stimulation and carer-led cognitive stimulation, this research sets out to develop and
      evaluate the potential benefits of iCST adapted for delivery by an interactive (touch-screen)
      web-application in a feasibility study. The investigators are setting out to combine the
      added value of computer use and the beneficial effects of CST/iCST in order to produce
      benefits in cognition and quality of life. A participatory process while developing the
      web-application in the form of consultations, focus groups and interviews will be employed.
      Preliminary consultations with people with dementia and their carers have already given the
      investigators information on attitudes towards (touch-screen) technology, both appealing and
      non-appealing features of applications and desired length/duration of iCST.

      The investigators hope to see signs of improvements in quality of life and cognition after
      using the iCST web-application. If this is the case, this could lead to a larger randomised
      controlled trial with more participants to formally establish effectiveness. An iCST
      web-application has the potential to be more accessible for people on a national and an
      international level when adapted to appropriate cultural contexts compared to paper-based
      manuals. Lastly, the iCST web-application could be used long-term and could rapidly become
      widely used as a clinically and cost-effective standardised, and feasible intervention.

      Design and methodology:

        1. The focus groups and interviews will be a multi-centre study to gain insights and
           perspectives from people with dementia and their carers regarding the usability of the
           iCST web-app. This will enable the investigators to optimise the developmental process
           and learn about the experiences of the participants while they interact with the
           web-application. Observational and transcribed audio-recorded data will be collected
           from the focus groups and interviews which will be semi-structured in nature.

        2. The feasibility study will be a multicentre, pragmatic, single blind, randomised 2
           treatment arm (iCST web-app vs treatment as usual) study over 11 weeks.

      In accordance with good research practice, the investigators have decided to run a
      feasibility study prior to running a larger randomised controlled trial in order to assess
      the usability of the iCST web-application and the feasibility of running a larger-scale
      randomised clinical trial. With this feasibility study the investigators will be able to gain
      insights with regard to recruitment/drop-out rates, adherence, sample size, appropriateness
      of outcome measures, changes to made to the web-application etc. This will all be necessary
      information before a larger trial can be conducted.

      Programme development:

      The iCST web-application will be adapted from the paper-based iCST manual. The amount of
      sessions will be reduced from 75 to 21 after consultations with people with dementia and
      carers pointed out that the paper-based iCST manual contained too many sessions. Multimedia
      within the web-application will be used and participants will be given the opportunity to
      provide ongoing feedback on the web-application itself after completing each session. The
      research team will work together with all the stakeholders such as the software company
      employed to build the web-application, the people with dementia, and their carers. Regular
      consultations, focus groups and interviews should aid the development of the web-application
      in ensuring it is feasible, practical and appealing.

      Recruitment for the study:

      Recruitment for the focus groups, interviews and feasibility study will take place in a
      variety of community settings in Nottingham consisting of both primary care settings
      (outpatient clinics) and secondary care settings (community mental health teams (CMHTs),
      memory clinics, care homes, day centres, and voluntary sector organizations such as the
      Alzheimer's Society). By including a variety of settings, the reach for people with dementia
      and their carers will be extended. The PhD student will make close links with the
      aforementioned services and organisations through attendance and regular contact. In
      addition, the distribution of information leaflets and posters to organisations and
      professionals involved in the identification of possible participants will facilitate the
      recruitment process.

      The initial approach will be from a member of the person with dementia's usual care team. If
      the person with dementia and carer are willing and suitable for participation, the PhD
      student will fully inform them about of all aspects pertaining to involvement in the study
      through in person conversations and information leaflets. It will be explained to the
      potential participant that; (i) entry into the study is entirely voluntary and that their
      treatment and care will not be affected by their decision, (ii) they can withdraw at any time
      but attempts will be made to avoid this occurrence and (iii) in the event of their withdrawal
      their data collected so far cannot be erased and we will seek consent to use the data in the
      final analyses where appropriate.

      Sample size:

      The sample size estimation for the focus groups and interviews is based on previous work in
      the iCST study. For the current study, four focus groups with six participants each (one with
      people with dementia, one with carers, two collaborative groups) and ten interviews (five
      with people with dementia and five with carers) will be conducted.

      The investigators have estimated the sample size to be 60 participants. This is partly based
      on previous work with iCST considering the numbers recruited and the amount of centres
      involved in the iCST trial. The iCST trial recruited 356 participants over eight sites across
      the UK (Bangor, Devon, Dorset, Hull, Lincolnshire, London, Manchester, Norfolk and Suffolk).
      This equals to an average of 45 dyads per site. We will have an equal distribution of dyads
      across the two groups leading to 30 dyads per arm (iCST web-application vs.
      treatment-as-usual). The field-testing phase of iCST (without a control group) included 22
      dyads which roughly resembles the sample size for the current feasibility study.

      A sample size of 60 participants will be sufficient to demonstrate the effectiveness of the
      iCST web-application with an effect size of 0.80 with 80% power and 5% significance
      (two-tailed). The effect size has been chosen based on the sample size.

      Timetable:

      Focus groups/interviews (start from May 2018 onwards):

        1. 3 months recruitment;

        2. 4 months running of groups and interviews in Nottingham recruitment

        3. 6 months analysis and writing up findings

      Feasibility trial (start from November 2018 onwards):

        1. 5 months of recruitment;

        2. 7 months of running feasibility study;

        3. 5 months analysis and writing up findings
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in cognition (person with dementia)
time frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline
description: ADAS-Cog: to measure the severity of the cognitive symptoms (memory, language, praxis, attention and other cognitive abilities)
measure: Change in quality of life (person with dementia)
time frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline
description: QoL-AD: self reporting questionnaire to investigate: physical health, energy, mood, living situation, memory, marriage, friends, chores, fun, money, self and life).
measure: Change in general health outcome (carer)
time frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline
description: EQ-5D: An instrument used to measure health outcome, it provides a descriptive profile for health status. It evaluates quality of life in carers.
measure: Depression (person with dementia)
time frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline
description: CSDD: to measure depressive symptoms: mood-related signs, behavioural disturbances, physical signs, biological functions and ideational disturbances
measure: Behavioural symptoms (person with dementia)
time frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline
description: NPI: to asses 10 behavioural disturbances: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy and aberrant motor activity.
measure: Activities of daily living (person with dementia)
time frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline
description: BADLS: BADLS is an instrument consisting of 20 daily-living abilities (basic and instrumental activities)
measure: Relation between person with dementia and carer (both)
time frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline
description: QPCR: a measure of relationship quality which will be completed by both the person with dementia and the carer
measure: Depression/anxiety (carer)
time frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline
description: HADS: is a useful measure anxiety and depression for carer. It consists of 14 questions (7 for anxiety and 7 for depression).
measure: Computer use self efficacy
time frame: Pre-intervention (baseline)
description: CUSE: will be used to assess self-efficacy beliefs in the context of computer/tablet use
measure: System usability
time frame: 11 weeks post baseline
description: SUS: is a widely-used questionnaire measuring the usability of a technology-based tool e.g. a computer program or other device.
arm group label: iCST web-application
arm group type: Experimental
description: A computerised cognitive stimulation programme consisting of 21 sessions.
arm group label: Treatment as usual (TAU)
arm group type: No Intervention
description: The control group will consist of a treatment-as-usual group and will not receive any additional intervention.
intervention type: Behavioral
intervention name: iCST web-application
description: The iCST web-application will be delivered by a carer in regular contact with the person with dementia (family carer, a close friend, or a volunteer befriender) for 1.5 hours a week. It is up to the carer to distribute the time in a matter that is convenient to them (e.g. two long sessions of 45 minutes or 3 shorter sessions of 30 minutes). Participants will be asked to use the web-application for a duration of 11 weeks at their homes. Each session will consist of structured cognitive stimulation aided by the use of multimedia. After completing each session, participants will be guided to a new screen on the web-application in which they will be asked to briefly reflect on the session and provide us with feedback.
arm group label: iCST web-application
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Orrell, MD, PhD
role: Study Chair
affiliation: University of Nottingham
last name: Justine Schneider, PhD
role: Study Director
affiliation: University of Nottingham
last name: Harleen Rai, MSc.
role: Principal Investigator
affiliation: University of Nottingham
last name: Lauren Yates, PhD
role: Study Director
affiliation: University of Nottingham
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
citation: Xavier AJ, d'Orsi E, de Oliveira CM, Orrell M, Demakakos P, Biddulph JP, Marmot MG. English Longitudinal Study of Aging: can Internet/E-mail use reduce cognitive decline? J Gerontol A Biol Sci Med Sci. 2014 Sep;69(9):1117-21. doi: 10.1093/gerona/glu105.
PMID: 25116923
citation: Almeida OP, Yeap BB, Alfonso H, Hankey GJ, Flicker L, Norman PE. Older men who use computers have lower risk of dementia. PLoS One. 2012;7(8):e44239. doi: 10.1371/journal.pone.0044239. Epub 2012 Aug 28.
PMID: 22937167
citation: Garcia-Casal JA, Loizeau A, Csipke E, Franco-Martin M, Perea-Bartolome MV, Orrell M. Computer-based cognitive interventions for people living with dementia: a systematic literature review and meta-analysis. Aging Ment Health. 2017 May;21(5):454-467. doi: 10.1080/13607863.2015.1132677. Epub 2016 Jan 25.
PMID: 26806365
citation: Tarraga L, Boada M, Modinos G, Espinosa A, Diego S, Morera A, Guitart M, Balcells J, Lopez OL, Becker JT. A randomised pilot study to assess the efficacy of an interactive, multimedia tool of cognitive stimulation in Alzheimer's disease. J Neurol Neurosurg Psychiatry. 2006 Oct;77(10):1116-21. doi: 10.1136/jnnp.2005.086074. Epub 2006 Jul 4.
PMID: 16820420
citation: Hodge, S., Hailey, E & Orrell, M. (eds) (2014). Memory Services National Accreditation Programme - Standards for Memory Services (4th Edition). London: Royal College of Psychiatrists.
citation: Spector, A., Thorgrimsen, L., Woods, B., & Orrell, M. (2006). Making a difference. London: Hawker Publications.
citation: Spector A, Thorgrimsen L, Woods B, Royan L, Davies S, Butterworth M, Orrell M. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Br J Psychiatry. 2003 Sep;183:248-54. doi: 10.1192/bjp.183.3.248.
PMID: 12948999
citation: Orrell M, Yates L, Leung P, Kang S, Hoare Z, Whitaker C, Burns A, Knapp M, Leroi I, Moniz-Cook E, Pearson S, Simpson S, Spector A, Roberts S, Russell I, de Waal H, Woods RT, Orgeta V. The impact of individual Cognitive Stimulation Therapy (iCST) on cognition, quality of life, caregiver health, and family relationships in dementia: A randomised controlled trial. PLoS Med. 2017 Mar 28;14(3):e1002269. doi: 10.1371/journal.pmed.1002269. eCollection 2017 Mar.
PMID: 28350796
citation: Yates LA, Orrell M, Spector A, Orgeta V. Service users' involvement in the development of individual Cognitive Stimulation Therapy (iCST) for dementia: a qualitative study. BMC Geriatr. 2015 Feb 6;15:4. doi: 10.1186/s12877-015-0004-5.
PMID: 25655940
citation: Orrell M, Aguirre E, Spector A, Hoare Z, Woods RT, Streater A, Donovan H, Hoe J, Knapp M, Whitaker C, Russell I. Maintenance cognitive stimulation therapy for dementia: single-blind, multicentre, pragmatic randomised controlled trial. Br J Psychiatry. 2014 Jun;204(6):454-61. doi: 10.1192/bjp.bp.113.137414. Epub 2014 Mar 27.
PMID: 24676963
citation: Yates LA, Leung P, Orgeta V, Spector A, Orrell M. The development of individual cognitive stimulation therapy (iCST) for dementia. Clin Interv Aging. 2014 Dec 30;10:95-104. doi: 10.2147/CIA.S73844. eCollection 2015.
PMID: 25565792
responsible party type: Sponsor
mesh term: Dementia
mesh term: Alzheimer Disease
sharing ipd: No