1. Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers (SHAPE): Study protocol for a multi-centre randomised controlled trial
- Author
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Testad, I, Clare, L, Anstey, K, Selbæk, G, Bjørkløf, GH, Henderson, C, Dalen, I, Gjestsen, MT, Rhodes, S, Røsvik, J, Bollen, J, Amos, J, Kajander, MM, Quinn, L, Knapp, M, Testad, I, Clare, L, Anstey, K, Selbæk, G, Bjørkløf, GH, Henderson, C, Dalen, I, Gjestsen, MT, Rhodes, S, Røsvik, J, Bollen, J, Amos, J, Kajander, MM, Quinn, L, and Knapp, M
- Abstract
Background: With an increasing number of people with dementia worldwide and limited advancement in medical treatments, the call for new and cost-effective approaches is crucial. The utility of self-management has been proven in certain chronic conditions. However, very little work has been undertaken regarding self-management in people with dementia. Methods: The SHAPE trial will include 372 people with mild to moderate dementia to evaluate the effectiveness and cost-effectiveness of an educational programme combining approaches of self-management, health promotion, and e-learning for care partners. The study is a multi-site, single-randomised, controlled, single-blinded trial with parallel arms. The intervention arm is compared with treatment as usual. The intervention comprises a 10-week course delivered as group sessions for the participants with dementia. The sessions are designed to develop self-management skills and to provide information on the nature of the condition and the development of healthy behaviours in a supportive learning environment. An e-learning course will be provided for care partners which covers similar and complementary material to that discussed in the group sessions for the participant with dementia. Discussion: This trial will explore the effect of the SHAPE group intervention on people with mild to moderate dementia in terms of self-efficacy and improvement in key health and mental health outcomes and cost-effectiveness, along with carer stress and knowledge of dementia. Trial registration: ClinicalTrials.gov Identifier: NCT04286139, registered prospectively February 26, 2020, https://clinicaltrials.gov/ct2/show/NCT04286139
- Published
- 2020