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

Dementia, Mild Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05450146
• Other study ID #: METC 2021-2955
• Secondary ID: 80-85200-98-2103
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: January 2024
• Source: Maastricht University
• Contact: Sander Osstyn, MSc
• Phone: +31 43 388 1137
• Email: s.osstyn[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 141
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Dementia, Mild

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Netherlands	Alzheimer Centrum Limburg	Maastricht	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University	VU University of Amsterdam, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-efficacy	The self-efficacy of informal caregivers measured by the Caregiver Self-efficacy Scale (CSES) (Fortinsky, 2002). The maximum and minimum answer scores range from 1 to 10 with higher scores indicating better outcomes.	24 months
Primary	Health-related quality-of-life	Health-related quality-of-life of the informal caregivers and persons with dementia measured by the EQ-5D-5L. The questionnaire is scored on a 5-point Likert scale.	24 months
Primary	Healthcare resource use	Healthcare resource use of the informal caregivers and persons with dementia measured by the Resource Utilization in Dementia (RUD) (Wimo, 2013).	24 months
Secondary	Depression and anxiety	Depression and anxiety of informal caregivers measured by the Hospital and Anxiety Depression Scale (HADS) (Bjelland, 2002). The questionnaire is scored on a 4-point Likert scale.	12 months
Secondary	Quality of life (informal caregiver)	Quality of life of informal caregivers measured by the Investigating Choice Experiments for the Preferences of Older People CAPability measure for Older people (ICECAP-O) (Makai, 2015). The questionnaire is scored on a 4-point Likert scale.	24 months
Secondary	Quality of life (person with dementia)	Quality of life of persons with dementia measured by the Quality of Life- Alzheimer's Disease scale (QOL-AD) (Logsdon et al., 2002). The questionnaire is scored on a 4-point Likert scale.	24 months
Secondary	Experienced burden of informal care	Experienced burden of informal caregivers measured by the EDIZ ("Ervaren Druk door Informele Zorg" / experienced burden of informal care) (Pot, 1995). The questionnaire is scored on a 5-point Likert scale.	12 months
Secondary	Participant characteristics	Characteristics of the informal caregivers and persons with dementia collected by the TOPICS-MDS questionnaire to capture TOPICS-MDS: demographic characteristics; relation between informal caregiver and person with dementia; perseverance time (informal caregiver); instrumental and personal activities of daily living (person with dementia)	baseline
Secondary	Cognitive status of the person with dementia as estimated by the informal caregiver	Cognitive status of the person with dementia as estimated by the informal caregiver measured by a selection of the Quick Dementia Rating System (QDRS). The questionnaire is scored on a 5-point Likert scale.	baseline