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

NCT05450146 | Recruiting

• 2 other identifiers: METC 2021-295580-85200-98-21039
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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).

Conditions

Dementia, Mild

Keywords

early-stage dementia; informal caregiver; informal care

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Depression and anxiety

  12 months

• Quality of life (informal caregiver)

  24 months

• Quality of life (person with dementia)

  24 months

• Experienced burden of informal care

  12 months

• Participant characteristics

  baseline

Study Arms (2)

Partner in Balance (intervention group)

EXPERIMENTAL

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

Other: Partner in Balance

Usual/standard care (control group)

NO INTERVENTION

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.

Interventions

Partner in Balance 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.

Partner in Balance (intervention group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University: lead
• VU University of Amsterdam: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Alzheimer Centrum Limburg

Maastricht, Limburg, 6221, Netherlands

RECRUITING

Related Publications (3)

• 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.

  PMID: 26932438 BACKGROUND

• 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.

  PMID: 27142676 BACKGROUND

• Osstyn SL, Handels R, Boots LMM, Balvert SCE, Evers SMAA, de Vugt ME. The effectiveness and health-economic evaluation of "Partner in Balance," a blended self-management program for early-stage dementia caregivers: study protocol for a cluster-randomized controlled trial. Trials. 2023 Jun 22;24(1):427. doi: 10.1186/s13063-023-07423-9.

  PMID: 37349828 DERIVED

MeSH Terms

Conditions

Dementia; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Marjolein de Vugt, professor

  Maastricht University

  STUDY DIRECTOR

Central Study Contacts

Sander Osstyn, MSc

CONTACT

+31 43 388 1137; s.osstyn@maastrichtuniversity.nl

Ron Handels, PhD

CONTACT

+31 43 38 81036; ron.handels@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: April 1, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2026
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

NL (1)