Dataset Information

An Individual Cognitive Stimulation Therapy App for People with Dementia and Carers: Results from a Feasibility Randomized Controlled Trial (RCT).

ABSTRACT:

Background

There is a lack of digital resources that 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. This study set out to determine the feasibility of conducting a full-scale, randomized controlled trial (RCT) with the iCST app.

Methods

This was a single blind, feasibility RCT including people with mild to moderate dementia and their carers. Multiple trial components were assessed including recruitment and retention rates, intervention fidelity and usability, and acceptability of the outcome assessments which included measures of cognition and QoL. A sample of the intervention group was invited to a semi-structured post-trial interview to examine the experience of using the iCST app.

Results

Sixty-one dyads were randomised to the iCST app (n = 31) or treatment-as-usual (TAU) control group (n = 30) for 11 weeks. In the iCST app group, 77% used the intervention for 20 minutes or more each week. Carers using the iCST app rated their QoL better at follow-up 2 compared to the TAU control group (EQ-5D, MD = 7.69, 95% CI = 2.32-13.06, p = 0.006). No significant differences were found on the other outcome measures.

Conclusion

The iCST app was deemed usable and enjoyable. Most participants completed the activities more quickly than anticipated and did not have enough activities to continue using the app frequently. Expansion of the iCST app is needed to maintain engagement for longer. Findings indicate that computerised cognitive stimulation can be beneficial, and a large-scale RCT is feasible with modifications to trial components. The results are relevant to researchers, software developers, policy-makers, people with dementia and carers who are looking to be involved in such interventions.

Trial registration

ClinicalTrials.gov, NCT03282877. Registered on 19 July 2017.

SUBMITTER: Rai HK

PROVIDER: S-EPMC8866989 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

An Individual Cognitive Stimulation Therapy App for People with Dementia and Carers: Results from a Feasibility Randomized Controlled Trial (RCT).

Rai Harleen Kaur HK Schneider Justine J Orrell Martin M

Clinical interventions in aging 20211222

<h4>Background</h4>There is a lack of digital resources that 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. This study set out to determine the feasibility of conducting a full-scale, randomized controlled trial (RCT) with the iCST app.<h4>Methods</h4>This was a si ...[more]

PMID: 35221680

Similar Datasets

Project description:BackgroundThere is a need for more resources to support the cognition and quality of life of people with dementia. The individual cognitive stimulation therapy (iCST) app aims to provide cognitive stimulation and social interaction to people with dementia and carers through interactive touchscreen technology. The iCST app has been developed according to the principles of CST and iCST, which have previously shown to improve the cognition and quality of life of people with dementia and benefit the relationship between the person with dementia and his/her carer. The iCST app has also shown to improve the quality of the carer's life.ObjectiveThe aim of this study is to evaluate the usability of the iCST app intervention and the feasibility of conducting a full-scale randomized controlled trial (RCT) to assess the clinical effectiveness of the iCST app intervention compared to that of treatment-as-usual for people with mild-to-moderate dementia.MethodsWe aim to recruit 60 people with mild-to-moderate dementia and their informal carers as dyads in a multi-center feasibility RCT with a treatment-as-usual control group. Both parties must be able to provide informed consent and participate in the intervention. Dyads will complete a baseline assessment that will include cognition and quality of life measures and they 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 at 11 weeks after the baseline assessments. 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 semistructured posttrial interview to further examine the experience of using the iCST app.ResultsThis study received funding in May 2015 and obtained ethical approval in March 2018. Data collection began in November 2018 and was completed in March 2020 with a total of 61 dyads recruited. Data analyses are in progress and the final results are expected to be available in the spring of 2021.ConclusionsThis 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 that of usual care alone. In addition, this study will 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.Trial registrationClinicalTrials.gov NCT03282877; https://clinicaltrials.gov/ct2/show/NCT03282877.International registered report identifier (irrid)DERR1-10.2196/24628.

Project description:BackgroundThere is a lack of technological resources for the mental stimulation and communication of people with dementia, which can be helpful in improving cognition and quality of life. Paper-based individual cognitive stimulation therapy (iCST) for people with dementia has the potential to be adapted to a touchscreen format. This can improve accessibility and provide mental stimulation using interactive features. There is a need for a rigorous and systematic approach toward development, leading to improved suitability and implementation of the intervention, so that more people can benefit from its use.ObjectiveThis study aims to develop and investigate the usability of Thinkability, an iCST app that can be used by people with dementia and carers on touchscreen tablets.MethodsThe Medical Research Council framework for evaluating complex interventions and the Centre for eHealth Research roadmap served as frameworks for the stages of intervention and technology development. The development of the iCST app itself adopted an agile approach with elements from action research. Hence, it was developed in 3 successive sprints and was evaluated by relevant stakeholders at each sprint. Sprint 1 included 2 patient and public involvement (PPI) consultation meetings, sprint 2 included 1 PPI consultation meeting, and 4 focus groups and 10 individual interviews were organized in sprint 3. A feasibility trial is currently underway.ResultsThe findings from each sprint were used to inform the development. Sprint 1 helped to identify the relevant evidence base and explored the attitudes of people with dementia and carers toward a potential iCST app. In sprint 2, an initial prototype was evaluated in a small PPI consultation meeting. In sprint 3, feedback was gathered through a qualitative study on the quality and perceived effectiveness of the iCST app. It was well received by people with dementia and carers. A need for more updated and personalized content was highlighted.ConclusionsThis study proves that an agile approach toward technology development involving all relevant stakeholders is effective in creating suitable technology. Adding to our previous knowledge of noncomputerized cognitive stimulation therapy, the release of the iCST app will make this psychosocial intervention accessible to more users worldwide.

Project description:IntroductionReducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding and can have a detrimental impact on mental and physical health and well-being. National policy guidelines recommend that carers' needs are considered and addressed; despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT).Methods and analysisFeasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1 year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions and problem-solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at 6 months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6 months including: level of disability, anxiety and depression, and quality of life.Ethics and disseminationFavourable ethical opinion was provided by East Midlands - Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences.Trial registration numberISRCTN15643456; Pre-results.

Project description:BackgroundOlder adult carers of people who experience psychosis are at increased risk of developing physical and mental health problems due to the compounding factors of supporting their care-recipient and the health changes associated with ageing. Effective interventions exist but can be difficult to access and maintain prolonged engagement. Self-directed writing therapies, frequently referred to as Written Emotional Disclosure (WED), might be a suitable alternative intervention to improve the wellbeing of carers.MethodsThis study aimed to determine the feasibility (recruitment, retention and primary outcome completion) and acceptability of a specific WED intervention known as Positive Written Disclosure (PWD). Informal carers of people with psychosis were randomised to PWD, neutral writing or no writing. Quantitative outcomes including positive and negative affect, carer wellbeing, quality of life, depression, anxiety, stress, self-efficacy, leisure time satisfaction as well as health care utilisation were collected at baseline, 1-, 3-, and 6-month assessments. Qualitative feedback was also collected via questionnaire and semi-structured interviews from those randomised to either writing group.ResultsWe successfully met our progression criteria, recruiting to target and within timeframes whilst attaining 97% retention and 84% primary outcome data completed at 6 months. Carers randomised to the positive writing group described the intervention as enabling them to have a more positive attitude and focus on activities for themselves. Both writing groups described their tasks as providing distraction from caring responsibilities. However, some carers found the narrow positive emotion focus challenging.ConclusionsPWD is a feasible and acceptable intervention for older adult carers of people with psychosis within a community setting. Further refinement of the writing protocol to include choice in type of emotion disclosed in addition to screening for some level of need may be required in future trials to reduce floor/ceiling effects of outcomes which may explain the lack of change observed.

Project description:BackgroundDiabetic foot ulcers (DFUs) cause significant morbidity affecting 19% to 34% of people living with diabetes mellitus. DFUs not only impair quality of life but may also result in limb loss and mortality. Patient education has been advocated to raise awareness of proper foot self-care and the necessity of seeking assistance when a foot wound occurs. Modern technologies, including mobile health (mHealth) interventions such as health apps, bring the potential for more cost-effective and scalable interventions.ObjectiveThis study aims to examine the feasibility and usability of a newly developed mHealth app called Well Feet, which is a diabetes and foot care education app for individuals at risk of developing DFU.MethodsWell Feet was developed using an evidence-based and expert panel cocreation approach to deliver educational content available in 3 languages (ie, English, Chinese, and Malay) via animation videos and a range of additional features, including adaptive learning. A nonrandomized, single-arm feasibility study using a mixed methods approach with a series of validated questionnaires and focus group discussions will be conducted. In total, 40 patients and carers will be recruited from a tertiary hospital diabetes clinic to receive a 1-month mHealth intervention. The primary outcomes are the usability of the app and a qualitative perspective on user experience. Secondary outcomes include changes in foot care knowledge, self-management behaviors, and quality of life.ResultsPatient recruitment began in July 2023, and the intervention and data collection will be completed by the end of September 2023. This study has been approved by National Healthcare Group Domain Specific Review Board (2022/00614) on February 10, 2023. The expected results will be published in spring 2024.ConclusionsThrough this feasibility study, the Well Feet DFU education app will undergo a comprehensive quantitative and qualitative evaluation of its usability and acceptance for future improvement in its design. With local contextualization, cultural adaptation, and its multilingual functionality, the app addresses a critical aspect of DFU health education and self-management in a multiethnic population. Findings from this study will refine and enhance the features of the app based on user feedback and shape the procedural framework for a subsequent randomized controlled trial to assess the effectiveness of Well Feet.Trial registrationClinicalTrials.gov NCT05564728; https://clinicaltrials.gov/study/NCT05564728.International registered report identifier (irrid)DERR1-10.2196/52036.

Dataset Information

An Individual Cognitive Stimulation Therapy App for People with Dementia and Carers: Results from a Feasibility Randomized Controlled Trial (RCT).

Background

Methods

Results

Conclusion

Trial registration

Publications

An Individual Cognitive Stimulation Therapy App for People with Dementia and Carers: Results from a Feasibility Randomized Controlled Trial (RCT).

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