Clinical trial NCT04286139: Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers
Official title: Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers - SHAPE: A Multicentre, Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Health promotion
Self-management
Online
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: The Research Council of Norway
name: Alzheimer's Society
name: National Health and Medical Research Council, Australia
name: University of Exeter
name: London School of Economics and Political Science
name: The University of New South Wales
name: The Hospital of Vestfold
First posted: 2020-02-26
Enrollment: 210
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in general self-efficacy
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Secondary outcomes:
measure: Change in mood (anxiety, depression)
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
measure: Change in wellbeing
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
measure: Change in Health-related Quality of life (HRQL)
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
measure: Change in Health-related Quality of life (HRQL)
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
measure: Change in Quality of life
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
measure: Change in health behaviours
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
measure: Change in cognition
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
measure: Cognition and function
timeFrame: Baseline
measure: Change in function
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
measure: Change in neuropsychiatric symptoms
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
measure: Change in carer stress
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
measure: Change in knowledge about dementia
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
measure: Change in perceived access to service use
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
measure: Change in cost of care
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
measure: Change in quality of adjusted life-years (QALY)
timeFrame: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Other outcomes:
measure: Promoting and hindering factors of the intervention
timeFrame: 3 months (Primary time-point)
measure: Replication and dissemination of the intervention
timeFrame: Baseline to 10 weeks
Locations:
city: Sydney
country: Australia
facility: Neuroscience Research Australia, University of New South Wales
state: New South Wales
city: Stavanger
country: Norway
facility: Centre for Age-related Medicine (SESAM), Stavanger University Hospital
state: Rogaland
city: Oslo
country: Norway
facility: Norwegian National Advisory Unit on Ageing and Health
city: Bodmin
country: United Kingdom
facility: Cornwall Partnership NHS Foundation Trust
state: Cornwall
city: Exeter
country: United Kingdom
facility: Devon Partnership NHS Trust
state: Devon
Study officials:
affiliation: Helse Stavanger HF
name: Ingelin Testad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Testad I, Clare L, Anstey K, Selbaek G, Bjorklof GH, Henderson C, Dalen I, Gjestsen MT, Rhodes S, Rosvik J, Bollen J, Amos J, Kajander MM, Quinn L, Knapp M. Self-management and HeAlth Promotion in Early-stage dementia with e-learning for carers (SHAPE): study protocol for a multi-centre randomised controlled trial. BMC Public Health. 2020 Oct 9;20(1):1508. doi: 10.1186/s12889-020-09590-9.