Support program for caregivers of people with early-stage dementia
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
NA · Maastricht University · NCT05450146
This study tests whether a new support program for caregivers of people with early-stage dementia can help them feel more confident and manage costs better compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 141 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University (other) |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT05450146 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on the Partner in Balance (PiB) program, which aims to enhance the self-efficacy of informal caregivers supporting individuals with early-stage dementia. The study compares the effectiveness and cost-effectiveness of the PiB intervention against usual care. It evaluates caregiver self-efficacy, total care costs, and the overall budget impact of implementing the PiB program. The goal is to provide evidence that could influence reimbursement decisions for this caregiver support initiative.
Who should consider this trial
Good fit: Ideal candidates for this study are informal caregivers of individuals with early-stage dementia who provide care more than twice a week without formal assistance.
Not a fit: Patients who are already receiving formal care or whose caregivers are participating in similar trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the well-being of caregivers and reduce overall care costs for patients with early-stage dementia.
How similar studies have performed: Previous studies have shown promising results in caregiver support interventions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * The informal caregiver is participating in another trial with similar objectives as this research. * The informal caregiver has a major mental or physical illness * The informal caregivers' person with dementia has a major mental or physical illness. * The dementia of the informal caregivers' person with dementia is caused by human immunodeficiency virus (HIV), acquired brain impairment, Down syndrome, chorea associated with Huntington's disease, or alcohol abuse. * Informal caregiver is younger than 18 years old. * Informal caregiver or person with dementia does not have a minimum understanding of Dutch language. * Informal caregiver has no basic internet skills. * Informal caregiver has no access to internet at home. * Informal caregiver has not received the online cursus 'Partner in Balance' yet. * Informal caregiver is not receiving a similar support program. * The informal caregiver is not able to follow COVID19 instructions. Type of dementia (e.g., Alzheimer, vascular) will not be a selection criterion.
Where this trial is running
Maastricht, Limburg
- Alzheimer Centrum Limburg — Maastricht, Limburg, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Sander Osstyn, MSc
- Email: s.osstyn@maastrichtuniversity.nl
- Phone: +31 43 388 1137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dementia, Mild, early-stage dementia, informal caregiver, informal care