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.


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: Identifier: NCT04286139, registered prospectively February 26, 2020,

Keywords: Carers; Cost-effectiveness; Dementia; E-learning; Group intervention; Health promotion; Intervention; Randomised controlled trial; Self-efficacy; Self-management.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Caregivers
  • Computer-Assisted Instruction*
  • Dementia* / therapy
  • Health Promotion
  • Humans
  • Multicenter Studies as Topic
  • Randomized Controlled Trials as Topic
  • Self-Management*

Associated data