SHAPE is short for Self-management and HeAlth Promotion in early-stage dementia with E-learning for carers. It was a multicentre, randomised, controlled trial. Below you will find adapted excerpts from the SHAPE-trial protocol.
Why SHAPE is important
The recent Lancet commission report on dementia estimated that 47 million people are living with dementia today. Novel and cost-effective approaches are needed to reduce the impact of the disease on the people with dementia, their care partners and society.
The SHAPE intervention was designed to meet the needs of people with dementia to maintain independence and dignity, improve health behaviours, and live well with the disease in their own home for as long as possible. To achieve this, we combined and adapted three existing interventions:
- Self-management intervention – Developed at the University of Exeter
- Health promotion intervention – Developed at the University of North Carolina, and adapted and applied at Stavanger University Hospital
- E-learning intervention – Developed at Neuroscience Research Australia (NeuRA)/ University of New South Wales (UNSW)
Read more about the components of the SHAPE trial
The project’s objectives
The primary objective was to evaluate how we can improve self-efficacy in people with dementia, by evaluating the effectiveness of the intervention compared to treatment as usual.
Secondary objectives were to evaluate the effectiveness of the SHAPE intervention in:
- Improving mood, well-being, quality of life and health outcomes in people with dementia
- Decreasing carer stress, general distress, knowledge about dementia and perceived access to support services
- Producing health behaviour changes based on self- and family report
- Estimate the costs and the cost-effectiveness of the self-management
Design of the SHAPE-trial
The study was a multi-site, single-randomised, controlled, single-blinded trial with parallel arms. The intervention arm was compared with treatment as usual. It evaluated the effectiveness of the educational programme for people with dementia combined with e-learning for their care partners. The SHAPE trial included people over the age of 65 with mild to moderate dementia. They participants had a care partner who was willing to participate as well. Read the full list of participation criteria
Regulatory and ethical approvals
The study was conducted in accordance with the recommendations for physicians involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions. The project got the appropriate ethical and regulatory approval prior to commencement in the respective countries. This includes approvals from the following:
- Regional Committees for Medical and Health Research Ethics (Norway)
- Health Regulation Authority and NHS Research Ethics Committee approval (UK)
- University of New South Wales Research Ethics Committee (Australia)
Who are responsible for the project?
- Coordinator: Norway, Ingelin Testad, Stavanger University Hospital
- Partner 2: Norway, Geir Selbæk, Norwegian National Advisory Unit on Ageing and Health
- Partner 3: United Kingdom, Linda Clare, University of Exeter
- Partner 4: United Kingdom, Martin Knapp, London School of Economics & Political Science
- Partner 5: Australia, Kaarin Anstey, University of New South Wales
External collaborators
- Slovenia, Marjeta Vodoncnik, Institute for Research, Education and Sustainable Development, Celje
- Austria, Stefanie Auer, Danube – University of Krems
Trial administration
Chief Investigator
Ingelin Testad
Co-investigators (PI)
Linda Clare
Trial Coordinators
Overall and Norwegian site coordinators
Martha Therese Gjestsen
UK site coordinators
Australian site coordinator
Sponsor
Funder
This is an EU Joint Programme – Neurodegenerative Disease Research project (JPND) JPND is the largest global research initiative aimed at tackling the challenge of neurodegenerative diseases. JPND aims to increase coordinated investment between participating countries in research aimed at finding causes, developing cures, and identifying appropriate ways to care for those with neurodegenerative diseases.
The project is supported through the following funding organisations under the aegis of JPND: Research Council Norway, Alzheimer’s Society (UK), National Health and Medical Research Council Australia.
