NCT04286139

Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers

Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers - SHAPE: A Multicentre, Randomised, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Helse Stavanger HF · Other Government
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess if an educational programme combining approaches of self-management, health promotion, and e-learning will improve self-efficacy and other key health and mental health outcomes for people with mild to moderate dementia.

Detailed description

It is currently estimated that 47 million people are living with dementia today and this number is expected to double in the next 20 years. Unfortunately, there has been limited advancement in medical treatments for dementia and new cost-effective approaches are needed. The utility of self-management has been proven to be of benefit in certain chronic diseases, however, very little work has been undertaken regarding self-management in people with dementia.The SHAPE self-management group therapy aims to significantly improve self-efficacy in people with mild to moderate dementia and to improve key health and mental health outcomes, carer stress and knowledge of dementia.SHAPE comprises a 10 week online 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 disease process and the development of healthy behaviours in a supportive learning environment to prevent problems that are common in the later stages of the disease. E-learning resources will be provided for carers (study supporters) which covers the similar and complimentary material discussed in the group sessions for the participant with dementia. This trial uses 2:1 randomisation and will assess the clinical and cost effectiveness of SHAPE. Participants will be randomised to participate in the SHAPE intervention or continue with usual care. To assess the effectiveness of SHAPE at improving self-efficacy and secondary outcomes a battery of questionnaires will be administered to the participants and study supporters at baseline, after SHAPE participants have completed the intervention, and 9 months after randomisation. The answers to these questionnaires will be assessed and the results compared between the two groups of participants.

Conditions

• Dementia

Interventions

Type	Name	Description
BEHAVIORAL	SHAPE	The SHAPE intervention provides information for carers, and maintains the dignity and autonomy of the person with dementia, supporting them in planning for the future with their family. The person with dementia attends an online 10 week facilitator lead group based course. It is designed to develop self-management skills in areas including decision-making, symptom management and social interaction. It also provides information on the disease process and the development of healthy behaviors in a supportive learning environment to prevent problems that are common in the later stages of the disease. The adjunctive e-learning platform for carers provides the same information that the person with dementia receives plus additional material and signposting to support them in their role. This will empower the whole family to support and enable more effective self-management by the person with dementia, and enhance their ability to plan ahead together and make key decisions jointly.

Timeline

• Start date: 2021-08-23
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2020-02-26
• Last updated: 2024-12-13

Locations

5 sites across 3 countries: Australia, Norway, United Kingdom