Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers – A randomised controlled trial

We will develop and validate an intervention (SHAPE) in 330 people with mild dementia; combining self-management, health promotion, and e-learning. The study is a multi-site, randomised, controlled, single-blinded trial with parallel groups. The intervention group is compared with treatment as usual (TAU). The primary outcome is to evaluate the effectiveness of the intervention in improving self-efficacy in people with dementia compared to treatment as usual (TAU). Secondary outcomes are to evaluate the effectiveness of the SHAPE intervention in (a) improving mood, well-being, quality of life and health outcomes in people with dementia compared to TAU; (b) decreasing carer stress, general distress, knowledge about dementia and perceived access to support services compared to TAU; (c) producing health behaviour changes based on self- and family report compared to TAU; d) reducing utilisation of health and social care and e) estimating the cost-effectiveness of the self-management compared to TAU (WP5). Our 36-month project is divided into eight work packages: Project management (WP1); Combining the interventions (WP2); Implementation Strategies (WP3); an RCT study (WP4) to measure health effects; a study of Economic effects (WP5); a Qualitative study (WP6) to understand and suggest improvement to the intervention; a Replication study (WP7) to prepare broader adoption; and Dissemination and Exploitation (WP8) to reach all stakeholders with targeted messages facilitating a broad reach and ensuring use of the intervention beyond the project.