Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers (SHAPE): study protocol for a mu
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STUDY PROTOCOL
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Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers (SHAPE): study protocol for a multicentre randomised controlled trial Ingelin Testad1,2,3* , Linda Clare4, Kaarin Anstey5,6, Geir Selbæk7,8,9, Guro Hanevold Bjørkløf7, Catherine Henderson10, Ingvild Dalen11, Martha Therese Gjestsen1, Shelley Rhodes2, Janne Røsvik7, Jessica Bollen2, Jessica Amos5, Martine Marie Kajander1,12, Lynne Quinn2 and Martin Knapp10
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 10week 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 costeffectiveness, 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 Keywords: Self-management, Health promotion, Dementia, Intervention, Group intervention, E-learning, Carers, Selfefficacy, Cost-effectiveness, Randomised controlled trial
* Correspondence: [email protected] 1 Centre for Age-related Medicine – SESAM, Stavanger University Hospital, Stavanger, Norway 2 University of Exeter, College of Medicine and Health, University of Exeter, Exeter, UK Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are
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