Trial-based Effectiveness and Cost-effectiveness of the Partner in Balance Intervention to Selfmanage Mild Dementia Via Blended eHealth Psycho-education and Behavioural Modelling for the Care Partner Coached by a Case Manager

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objectives: The investigators aim to answer the following research questions: * What is the effect of PiB on caregiver self-efficacy compared to usual care? * What is the effect of PiB on caregiver and person with dementia total care costs compared to usual care? * What is the incremental cost-utility ratio of PiB compared to usual care? * What is the annual budget impact of PiB compared to usual care? Study design: Pragmatic, cluster randomised controlled trial. Study population: Informal caregivers of people with early-stage dementia who are community-dwelling and are receiving little or no dementia-related formal ADL-care Intervention: blended E-health informal caregiver support program with online psycho-education and behavioural modelling. It contains personalized goal setting, online modules with option for online communication with care professional, evaluation with care professional. Main study parameters/endpoints: Primary: self-efficacy. Cost-utility: EQ5D, RUD. Secondary: quality-of-life, caregiver burden Data collection: Measurements consist of questionnaires (total duration is approximately 1 hour; administered at home, via telephone, via email or other location if preferred by the participant; take place at baseline, 3, 6, 12 and 24 months).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Subject is an informal caregiver of a person with early stage dementia.

• The caregiver provides support for a person with dementia who is diagnosed of dementia (self-reported or known by the recruiting organization) or underdiagnosed dementia (no formal diagnosis but symptoms of dementia)

• The caregiver provides support for a person with dementia who is not yet receiving formal care related to personal activities of daily living on account of his/her dementia more than two times a week (defined by receiving assistance from a paid worker by e.g., health or social care such as help with dressing/undressing, washing/bathing/showering, toileting, feeding/drinking, taking medication or attending day activity or day care centre).

Locations
Other Locations
Netherlands
Alzheimer Centrum Limburg
RECRUITING
Maastricht
Contact Information
Primary
Sander Osstyn, MSc
s.osstyn@maastrichtuniversity.nl
+31 43 388 1137
Backup
Ron Handels, PhD
ron.handels@maastrichtuniversity.nl
+31 43 38 81036
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 141
Treatments
Experimental: Partner in Balance (intervention group)
Informal caregivers assigned to the intervention group will receive the 8-week online selfmanagement program Partner in Balance (Boots, 2018).
No_intervention: Usual/standard care (control group)
Participants in the comparison condition will continue to receive the care as usual.~The control group will be shared with another collaborating study from the 'Vrije Universiteit of Amsterdam'), which has the same goals, applies the same inclusion criteria, applies the same study procedures, and obtains the same outcomes. This implies that the data of the participants recruited for the control group for this study will be shared with the collaborating study.
Related Therapeutic Areas
Sponsors
Collaborators: VU University of Amsterdam, ZonMw: The Netherlands Organisation for Health Research and Development
Leads: Maastricht University

This content was sourced from clinicaltrials.gov