Trial-based Effectiveness and Cost-effectiveness of the Partner in Balance Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2026-02-28

Brief Summary

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Rationale:

Informal care is one of the most important sources of care for dependent elderly people. The Partner in Balance (PIB) intervention aims to prepare and support informal caregivers for their caregiving tasks. Long-term cost-effectiveness evidence is required to support reimbursement decision-making on this PIB program. The investigators hypothesize that 1) caregiver self-efficacy in intervention arm PiB is higher compared to the control arm of usual care; 2) care costs of participants in intervention arm are lower compared to the control arm of usual care.

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).

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Detailed Description

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Conditions

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Dementia, Mild

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Partner in Balance

Intervention Type OTHER

The "Partner in Balance" intervention (Boots, 2018) consists of 1) a face-to-face intake session with a care professional (casemanagers, dementia nurses or district nurses) to familiarize participants with the program, set goals, and select preferred module themes; 2) tailored online thematic modules, including psychoeducation, behavioral modeling, reflective assignments, set goals, and online messaging feedback with the care professional over 8 weeks; and 3) a face-to-face evaluation session with the care professional evaluating previously set goals.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Partner in Balance

The "Partner in Balance" intervention (Boots, 2018) consists of 1) a face-to-face intake session with a care professional (casemanagers, dementia nurses or district nurses) to familiarize participants with the program, set goals, and select preferred module themes; 2) tailored online thematic modules, including psychoeducation, behavioral modeling, reflective assignments, set goals, and online messaging feedback with the care professional over 8 weeks; and 3) a face-to-face evaluation session with the care professional evaluating previously set goals.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes