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

Maastricht University

Status: Enrolling

Conditions: Dementia, Mild

Treatments: Other: Partner in Balance

Study type: Interventional

Funder types: Other

Identifiers

NCT05450146

METC 2021-2955

80-85200-98-21039 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment: 141 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 2 patient groups

Partner in Balance (intervention group)

Experimental group

Description:

Informal caregivers assigned to the intervention group will receive the 8-week online selfmanagement program "Partner in Balance" (Boots, 2018).

Treatment:

Other: Partner in Balance

Usual/standard care (control group)

No Intervention group

Description:

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.