Currently submitted to: JMIR Research Protocols
Date Submitted: Sep 28, 2020
Open Peer Review Period: Sep 28, 2020 - Nov 23, 2020
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An Individual Cognitive Stimulation Therapy Application (iCST app) for People With Dementia and Carers: Protocol for a Feasibility Randomized Controlled Trial.
There is a need for more resources to support the cognition and quality of life (QoL) of people with dementia. The individual Cognitive Stimulation Therapy application (iCST app) aims to provide cognitive stimulation and social interaction to people with dementia and carers through interactive touch-screen technology. It has been developed according to the principles of CST and iCST which have previously shown to improve the cognition and QoL of people with dementia, and to benefit the relationship between the person with dementia and carer, while improving quality of the carer’s life. This study aims to evaluate the feasibility of conducting a full-scale, randomized controlled trial (RCT) with the iCST app.
To evaluate the feasibility of conducting a full-scale RCT with the iCST app compared to a treatment as usual (TAU) control group.
A multi-centre, pragmatic, single blind, feasibility RCT with a treatment as usual (TAU) control group. This study aims to recruit 60 people with mild to moderate dementia and their informal carers as dyads. Both parties must be able to provide informed consent and participate in the intervention. Dyads will complete a baseline assessment which will include cognition and QoL measures, and will subsequently be randomized (1:1) to the iCST app intervention in addition to usual care, or to usual care only. All participants will be followed-up at 5 weeks and 11 weeks post-baseline. A range of feasibility outcomes will be assessed including recruitment and retention rates, intervention fidelity and usability, and acceptability of the outcome measures. A sample of the experimental group will be invited to a semi-structured post-trial interview to further examine the experience of using the iCST app.
Recruitment began in November 2018 with 43 dyads recruited from primary and secondary care settings. Participants were randomized to the iCST app (n = 21) or TAU control group (n = 22) with a relatively low attrition rate throughout the study (n = 2). Dementia support groups and (online) research databases led to the majority of the referrals for the study.
This study will investigate whether it is feasible to conduct a full-scale RCT to evaluate the clinical effectiveness of the iCST app in comparison to usual care alone. In addition, it will further examine the usability of the iCST app. The data will provide information on potential modifications to be made to the intervention, study design, and study process. Clinical Trial: ClinicalTrials.gov, NCT03282877. Registered on 19 July 2017.
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