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

Helse Stavanger HF

Status: Completed

Conditions: Dementia

Treatments: Behavioral: SHAPE

Study type: Interventional

Funder types: Other

Identifiers

NCT04286139

258388

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 2 patient groups

SHAPE Intervention

Experimental group

Description:

This group will receive the online group based self-management course develop self-management skills in areas including decision making, symptom management and social interaction 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. Key themes of the intervention will include positive actions to improve and maintain health, how to talk about the impact of the disease on the life of the person with dementia, fear of losing independence and how to tackle and solve other sensitive issues. Running in parallel there will be an e-learning resource available to the carers which covers the similar material covered in the group sessions for the person with dementia, as well as some additional resources and signposting to help them in their role supporting the person with dementia.

Treatment:

Behavioral: SHAPE

Treatment as usual

No Intervention group

Description:

Participants in the TAU arm will receive normal services such as clinical reviews, psychiatric appointments and other services when needed. With TAU as the comparator condition ensures that participants receive any needed services and enable comparison between current best practice and the new intervention of SHAPE