Clinical trial NCT05450146: Trial-based Effectiveness and Cost-effectiveness of the Partner in Balance Intervention
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia, Mild
Keywords: early-stage dementia
informal caregiver
informal care
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-07-08
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility 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.

Primary outcomes:
measure: Self-efficacy
timeFrame: 24 months
measure: Health-related quality-of-life
timeFrame: 24 months
measure: Healthcare resource use
timeFrame: 24 months
Secondary outcomes:
measure: Depression and anxiety
timeFrame: 12 months
measure: Quality of life (informal caregiver)
timeFrame: 24 months
measure: Quality of life (person with dementia)
timeFrame: 24 months
measure: Experienced burden of informal care
timeFrame: 12 months
measure: Participant characteristics
timeFrame: baseline
measure: Cognitive status of the person with dementia as estimated by the informal caregiver
timeFrame: baseline
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Alzheimer Centrum Limburg
state: Limburg
Study officials:
affiliation: Maastricht University
name: Marjolein de Vugt, professor
role: STUDY_DIRECTOR
References:
citation: Boots LM, de Vugt ME, Withagen HE, Kempen GI, Verhey FR. Development and Initial Evaluation of the Web-Based Self-Management Program "Partner in Balance" for Family Caregivers of People With Early Stage Dementia: An Exploratory Mixed-Methods Study. JMIR Res Protoc. 2016 Mar 1;5(1):e33. doi: 10.2196/resprot.5142.
citation: Boots LM, de Vugt ME, Kempen GI, Verhey FR. Effectiveness of the blended care self-management program "Partner in Balance" for early-stage dementia caregivers: study protocol for a randomized controlled trial. Trials. 2016 May 4;17(1):231. doi: 10.1186/s13063-016-1351-z.