Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers - SHAPE: A Multicentre, Randomised, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Helse Stavanger HF
- Enrollment
- 210
- Locations
- 10
- Primary Endpoint
- Change in general self-efficacy
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of dementia according to the ICD-10 classification or the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or V
- •65 years of age or older
- •Mild to moderate dementia, as associated with tMMSE ≥15
- •Ability to read and write
- •Hearing and vision that are sufficiently good to work in a group setting
- •Capacity to give consent for participation in the study
- •Proficient in the language in which the intervention is provided
- •Care partner willing to participate
Exclusion Criteria
- •A diagnosis of alcohol or drug abuse
- •Lewy body dementias, Fronto-temporal lobar degeneration or Semantic dementia
- •A limited life expectancy due to any terminal disease or other serious illness, other than dementia
- •Chemotherapy or radiation treatment ongoing at enrolment
- •Currently participating in health promotion or self-management group
Outcomes
Primary Outcomes
Change in general self-efficacy
Time Frame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Measured by the General Self-Efficacy Scale, a 10-item psychometric scale where each item is scored on a 4 point scale ranging from 'Not at all true' to 'Hardly true', to assess optimistic self-beliefs to cope with a variety of difficult demands in life.
Secondary Outcomes
- Change in wellbeing(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in cognition(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in mood (anxiety, depression)(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in Quality of life(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in health behaviours(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Cognition and function(Baseline)
- Change in neuropsychiatric symptoms(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in knowledge about dementia(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in quality of adjusted life-years (QALY)(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in carer stress(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in perceived access to service use(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in cost of care(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in function(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in Health-related Quality of life (HRQL)(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))