Dataset Information

Individual cognitive stimulation therapy for people with intellectual disability and dementia: protocol of a feasibility randomised controlled trial.

ABSTRACT:

Introduction

Cognitive stimulation therapy (CST) is a psychosocial intervention for dementia. Group CST is effective in reducing cognitive decline and improving quality of life in patients with dementia. There is some evidence that individual CST (iCST) may be beneficial in reducing cognitive decline. People with intellectual disability (ID) have an increased risk of dementia. However, there are no published studies of CST in people with ID and dementia. This protocol describes the feasibility and acceptability of a randomised controlled trial of iCST delivered by carers to people with ID and dementia, compared with treatment as usual (TAU). The results of this study will inform the design of a future definitive randomised controlled trial.

Methods and analysis

The iCST intervention has been adapted for this trial. Forty dyads (individuals with ID and their carer) will be randomised to either iCST or TAU. The manualised intervention comprises 40 iCST sessions delivered by a carer for 30?min, twice a week, over 20?weeks. The primary outcome will be process measures assessing the feasibility and acceptability of the intervention and trial procedures. The secondary outcome will be changes in the scores of outcome measures (cognition, functional ability and quality of life in individuals with ID, and caregiver burden, competence in managing dementia, and anxiety and depression in carers). Data will be collected at baseline, 11?weeks and at 21?weeks. A process evaluation will examine adherence to iCST and will include qualitative interviews with participants to identify aspects of the intervention that were or were not successful.

Ethics and dissemination

The study has received ethical approval. The results of the study will be presented at conferences and submitted to a peer reviewed journal.

Trial registration number

ISRCTN18312288; Pre-results.

SUBMITTER: Ali A

PROVIDER: S-EPMC6292419 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Publications

Individual cognitive stimulation therapy for people with intellectual disability and dementia: protocol of a feasibility randomised controlled trial.

Ali Afia A Brown Emma E Spector Aimee A Aguirre Elisa E Hassiotis Angela A

BMJ open 20181209 12

<h4>Introduction</h4>Cognitive stimulation therapy (CST) is a psychosocial intervention for dementia. Group CST is effective in reducing cognitive decline and improving quality of life in patients with dementia. There is some evidence that individual CST (iCST) may be beneficial in reducing cognitive decline. People with intellectual disability (ID) have an increased risk of dementia. However, there are no published studies of CST in people with ID and dementia. This protocol describes the feasi ...[more]

PMID: 30530576

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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:IntroductionMany people living with advanced dementia live and die in nursing care homes. The quality of life, care and dying experienced by these people is variable. Namaste Care is a multisensory programme of care developed for people with advanced dementia. While there is emerging evidence that Namaste Care may be beneficial for people with dementia, there is a need to conduct a feasibility study to establish the optimum way of delivering this complex intervention and whether benefits can be demonstrated in end-of-life care, for individuals and service delivery. The aim of the study is to ascertain the feasibility of conducting a full trial of the Namaste Care intervention.Methods and analysisA feasibility study, comprising a parallel, two-arm, multicentre cluster controlled randomised trial with embedded process and economic evaluation. Nursing care homes (total of eight) who deliver care to those with advanced dementia will be randomly allocated to intervention (delivered at nursing care home level) or control. Three participant groups will be recruited: residents with advanced dementia, informal carers of a participating resident and nursing care home staff. Data will be collected for 6 months. Feasibility objectives concern the recruitment and sampling of nursing homes, residents, informal carers and staff; the selection and timing of primary (quality of dying and quality of life) and secondary clinical outcome measures (person centredness, symptom presence, agitation, quality of life, resource use and costs and residents' activity monitored using actigraphy). Acceptability, fidelity and sustainability of the intervention will be assessed using semistructured interviews with staff and informal carers.Ethics and disseminationThis protocol has been approved by NHS Wales Research Ethics Committee 5 (ref: 17/WA0378). Dissemination plans include working with a public involvement panel, through a website (http://www.namastetrial.org.uk), social media, academic and practice conferences and via peer reviewed publications.Trial registration numberISRCTN14948133; Pre-results.

Project description:BackgroundA dementia diagnosis can prevent people from participating in society, leading to a further decline in cognitive, social and physical health. However, it may be possible for people with dementia to continue to live meaningful lives and continue to participate actively in society if a supportive psychosocial environment exists. Resilience theory, which focuses on strengthening personal attributes and external assets in the face of serious challenges, may provide a scaffold on which an inclusive multifaceted psychosocial supportive environment can be built. This protocol paper describes a study to determine the feasibility of conducting a multifaceted complex resilience building psychosocial intervention for people with dementia and their caregivers living in the community.MethodsThis is a non-randomised feasibility study. Ten participants with dementia and their primary caregivers living in the community will be recruited and receive the CREST intervention. The intervention provides (a) a 7-week cognitive stimulation programme followed by an 8-week physical exercise programme for people with dementia and (b) a 6-week educational programme for caregivers. Members of the wider community will be invited to a dementia awareness programme and GP practices to a dementia training workshop. Trained professionals will deliver all intervention components. Outcomes will assess the feasibility and acceptability of all study processes. The feasibility and acceptability of a range of outcomes to be collected in a future definitive trial, including economic measurements, will also be explored. Finally, social marketing will be used to map a route toward stigma change in dementia for use in a subsequent trial. Quantitative feasibility outcome assessments will be completed at baseline and after completion of the 15-week intervention while qualitative data will be collected at recruitment, baseline, during and post-intervention delivery.ConclusionThis feasibility study will provide evidence regarding the feasibility and acceptability of a comprehensive multifaceted psychosocial intervention programme for people with dementia and their caregivers (CREST). The results will be used to inform the development and implementation of a subsequent RCT, should the findings support feasibility.Trial registrationISRCTN25294519 Retrospectively registered 07.10.2019.

Project description:BACKGROUND:Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. METHODS/DESIGN:PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month's post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. DISCUSSION:This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial. TRIAL REGISTRATION:ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

Project description:BackgroundPeople living with dementia (PLwD) have a high fall risk as cognitive impairment compromises control of gait and balance. Fall prevention exercises that are effective in healthy older adults may not work for PLwD. Cognitive stimulation therapy (CST) has been shown to improve global cognition in PLwD. A programme which combines cognitive (CST) with physical exercises may reduce falls in PLwD. The aim of this study was to assess the feasibility of undertaking a full scale randomised controlled trial to test the effectiveness of CogEx in decreasing falls in PLwD. Specific objectives included recruitment strategy, data collection, outcome measures, intervention fidelity and facilitator/participant experience.MethodsA mixed methods feasibility randomised controlled trial recruited people from residential aged care. Inclusion criteria were ≥ 65 years old, Montreal Cognitive Assessment (MoCA) score of 10 to 26 and able to participate in a group. Participants were randomised to CST or CST combined with strength and balance exercises (CogEx). Both CST and CogEx groups were for an hour twice a week for 7 weeks. Descriptive statistics were used to report pre- and post-intervention outcome measures (MoCA, Geriatric Depression Scale-15, Quality of Life-Alzheimer's Disease, Alzheimer's Disease Assessment Scale-Cognitive 11, Brief Balance Evaluation Systems Test and Short Form Physical Performance Battery) and attendance. Qualitative analysis of participant focus groups and facilitator interviews used a conventional approach. Sessions were video recorded and exercise completion documented.ResultsThirty-six residents were screened with 23 participants randomised to intervention (CogEx, n = 10) or control (CST, n = 13). The assessments took 45 min to 1.5 h, and there was repetition between two cognitive measures. Ten facilitators completed training with the manualised programme. Exercises were combined into the hour-long CST session; however, limited balance training occurred with participants exercising predominantly in sitting. The facilitators felt the participants engaged more and were safer in sitting.ConclusionsThe results demonstrated that while fall prevention exercises could be scheduled into the CST structure, the fidelity of the combined programme was poor. Other components of the study design need further consideration before evaluation using a randomised controlled trial is feasible.Trial registrationanzctr.org.au (ACTRN12616000751471) 8 Jun 2016, Australian New Zealand Clinical Trials Registry.

Project description:INTRODUCTION:The aim of this review is to answer the following question: Does assistive technology contribute to social inclusion for people with intellectual disability? Previous research on assistive technology has focused on socioeconomic impacts such as education, employment and access to healthcare by people with intellectual disability. There is a need to consolidate evidence on the interaction between intellectual disability, assistive technology, community living and social inclusion. METHODS AND ANALYSIS:The review will consider studies from all settings: geographical, socioeconomic and care (institutional and community care), published in English. Studies reported in other languages with abstracts in English will be included if they can be translated using Google Translate, otherwise such studies will be included in the appendix. The review will include both qualitative and quantitative studies. The intervention in this review refers to the use of assistive technology to promote community participation or interpersonal relationships (social inclusion) for people with intellectual disability. The outcomes will be behavioural and social benefits of using assistive technology by people with intellectual disability. Enhanced interpersonal relationships and community participation by people with intellectual disability. Data analysis will be in two phases. The first phase will involve analysis of individual study designs separately. The second phase will be narrative/thematic synthesis of all study groups. ETHICS:The review will not create any ethical or safety concerns. DISSEMINATION:At least one peer-reviewed article in a leading journal such as the BMJ is planned. The findings will also be disseminated through a seminar session involving internal audience at Trinity College Dublin and within the Assistive Technologies for people with Intellectual Disability and Autism research programme. PROSPERO REGISTRATION NUMBER:CRD42017065447; Pre-results.

Dataset Information

Individual cognitive stimulation therapy for people with intellectual disability and dementia: protocol of a feasibility randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Individual cognitive stimulation therapy for people with intellectual disability and dementia: protocol of a feasibility randomised controlled trial.

Similar Datasets

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