Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers
NCT ID: NCT04286139
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
210 participants
INTERVENTIONAL
2021-08-23
2024-05-31
Brief Summary
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Detailed Description
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This trial uses 2:1 randomisation and will assess the clinical and cost effectiveness of SHAPE. Participants will be randomised to participate in the SHAPE intervention or continue with usual care. To assess the effectiveness of SHAPE at improving self-efficacy and secondary outcomes a battery of questionnaires will be administered to the participants and study supporters at baseline, after SHAPE participants have completed the intervention, and 9 months after randomisation. The answers to these questionnaires will be assessed and the results compared between the two groups of participants.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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SHAPE Intervention
This group will receive the online group based self-management course develop self-management skills in areas including decision making, symptom management and social interaction and to provide information on the disease process and the development of healthy behaviours in a supportive learning environment to prevent problems that are common in the later stages of the disease. Key themes of the intervention will include positive actions to improve and maintain health, how to talk about the impact of the disease on the life of the person with dementia, fear of losing independence and how to tackle and solve other sensitive issues. Running in parallel there will be an e-learning resource available to the carers which covers the similar material covered in the group sessions for the person with dementia, as well as some additional resources and signposting to help them in their role supporting the person with dementia.
SHAPE
The SHAPE intervention provides information for carers, and maintains the dignity and autonomy of the person with dementia, supporting them in planning for the future with their family. The person with dementia attends an online 10 week facilitator lead group based course. It is designed to develop self-management skills in areas including decision-making, symptom management and social interaction. It also provides information on the disease process and the development of healthy behaviors in a supportive learning environment to prevent problems that are common in the later stages of the disease. The adjunctive e-learning platform for carers provides the same information that the person with dementia receives plus additional material and signposting to support them in their role. This will empower the whole family to support and enable more effective self-management by the person with dementia, and enhance their ability to plan ahead together and make key decisions jointly.
Treatment as usual
Participants in the TAU arm will receive normal services such as clinical reviews, psychiatric appointments and other services when needed. With TAU as the comparator condition ensures that participants receive any needed services and enable comparison between current best practice and the new intervention of SHAPE
No interventions assigned to this group
Interventions
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SHAPE
The SHAPE intervention provides information for carers, and maintains the dignity and autonomy of the person with dementia, supporting them in planning for the future with their family. The person with dementia attends an online 10 week facilitator lead group based course. It is designed to develop self-management skills in areas including decision-making, symptom management and social interaction. It also provides information on the disease process and the development of healthy behaviors in a supportive learning environment to prevent problems that are common in the later stages of the disease. The adjunctive e-learning platform for carers provides the same information that the person with dementia receives plus additional material and signposting to support them in their role. This will empower the whole family to support and enable more effective self-management by the person with dementia, and enhance their ability to plan ahead together and make key decisions jointly.
Eligibility Criteria
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Inclusion Criteria
* 65 years of age or older
* Mild to moderate dementia, as associated with tMMSE ≥15
* Ability to read and write
* Hearing and vision that are sufficiently good to work in a group setting
* Capacity to give consent for participation in the study
* Proficient in the language in which the intervention is provided
* Care partner willing to participate
Exclusion Criteria
* Lewy body dementias, Fronto-temporal lobar degeneration or Semantic dementia
* A limited life expectancy due to any terminal disease or other serious illness, other than dementia
* Chemotherapy or radiation treatment ongoing at enrolment
* Currently participating in health promotion or self-management group
65 Years
ALL
No
Sponsors
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The Research Council of Norway
OTHER
Alzheimer's Society
OTHER
National Health and Medical Research Council, Australia
OTHER
University of Exeter
OTHER
London School of Economics and Political Science
OTHER
The University of New South Wales
OTHER
The Hospital of Vestfold
OTHER
Helse Stavanger HF
OTHER_GOV
Responsible Party
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Principal Investigators
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Ingelin Testad, PhD
Role: PRINCIPAL_INVESTIGATOR
Helse Stavanger HF
Locations
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Neuroscience Research Australia, University of New South Wales
Sydney, New South Wales, Australia
Centre for Age-related Medicine (SESAM), Stavanger University Hospital
Stavanger, Rogaland, Norway
Norwegian National Advisory Unit on Ageing and Health
Oslo, , Norway
Cornwall Partnership NHS Foundation Trust
Bodmin, Cornwall, United Kingdom
Devon Partnership NHS Trust
Exeter, Devon, United Kingdom
Countries
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References
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Testad I, Clare L, Anstey K, Selbaek G, Bjorklof GH, Henderson C, Dalen I, Gjestsen MT, Rhodes S, Rosvik J, Bollen J, Amos J, Kajander MM, Quinn L, Knapp M. Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers (SHAPE): study protocol for a multi-centre randomised controlled trial. BMC Public Health. 2020 Oct 9;20(1):1508. doi: 10.1186/s12889-020-09590-9.
Other Identifiers
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258388
Identifier Type: -
Identifier Source: org_study_id