iCST Web-application for People With Dementia
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|ClinicalTrials.gov Identifier: NCT03282877|
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : November 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mild Dementia Moderate Dementia||Behavioral: iCST web-application||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Adapting Individual Cognitive Stimulation Therapy (iCST) for Delivery by a Web-application|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: iCST web-application
A computerised cognitive stimulation programme consisting of 21 sessions.
Behavioral: iCST web-application
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.
No Intervention: Treatment as usual (TAU)
The control group will consist of a treatment-as-usual group and will not receive any additional intervention.
- Change in cognition (person with dementia) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]ADAS-Cog: to measure the severity of the cognitive symptoms (memory, language, praxis, attention and other cognitive abilities)
- Change in quality of life (person with dementia) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]QoL-AD: self reporting questionnaire to investigate: physical health, energy, mood, living situation, memory, marriage, friends, chores, fun, money, self and life).
- Change in general health outcome (carer) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]EQ-5D: An instrument used to measure health outcome, it provides a descriptive profile for health status. It evaluates quality of life in carers.
- Depression (person with dementia) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]CSDD: to measure depressive symptoms: mood-related signs, behavioural disturbances, physical signs, biological functions and ideational disturbances
- Behavioural symptoms (person with dementia) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]NPI: to asses 10 behavioural disturbances: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy and aberrant motor activity.
- Activities of daily living (person with dementia) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]BADLS: BADLS is an instrument consisting of 20 daily-living abilities (basic and instrumental activities)
- Relation between person with dementia and carer (both) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]QPCR: a measure of relationship quality which will be completed by both the person with dementia and the carer
- Depression/anxiety (carer) [ Time Frame: Pre-intervention (baseline), 5 weeks post baseline, 11 weeks post baseline ]HADS: is a useful measure anxiety and depression for carer. It consists of 14 questions (7 for anxiety and 7 for depression).
- Computer use self efficacy [ Time Frame: Pre-intervention (baseline) ]CUSE: will be used to assess self-efficacy beliefs in the context of computer/tablet use
- System usability [ Time Frame: 11 weeks post baseline ]SUS: is a widely-used questionnaire measuring the usability of a technology-based tool e.g. a computer program or other device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282877
|Contact: Harleen Rai, MSc.||+441157484252||Harleen.Rai@nottingham.ac.uk|
|Contact: Martin Orrell, MD, PhD||+441158231291||M.Orrell@nottingham.ac.uk|
|Nottinghamshire Healthcare NHS Trust||Recruiting|
|Nottingham, United Kingdom|
|Study Chair:||Martin Orrell, MD, PhD||University of Nottingham|
|Study Director:||Justine Schneider, PhD||University of Nottingham|
|Principal Investigator:||Harleen Rai, MSc.||University of Nottingham|
|Study Director:||Lauren Yates, PhD||University of Nottingham|