search
Back to results

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

Primary Purpose

Dementia, Mild

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Partner in Balance
Sponsored by
Maastricht University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dementia, Mild focused on measuring early-stage dementia, informal caregiver, informal care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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 once 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.

Sites / Locations

  • Alzheimer Centrum LimburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Partner in Balance (intervention group)

Usual/standard care (control group)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
Healthcare resource use
Healthcare resource use of the informal caregivers and persons with dementia measured by the Resource Utilization in Dementia (RUD) (Wimo, 2013).

Secondary Outcome Measures

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.
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.
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.
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.
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)
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.

Full Information

First Posted
July 4, 2022
Last Updated
June 13, 2023
Sponsor
Maastricht University
Collaborators
VU University of Amsterdam, ZonMw: The Netherlands Organisation for Health Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT05450146
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University
Collaborators
VU University of Amsterdam, ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Mild
Keywords
early-stage dementia, informal caregiver, informal care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Partner in Balance (intervention group)
Arm Type
Experimental
Arm Description
Informal caregivers assigned to the intervention group will receive the 8-week online selfmanagement program "Partner in Balance" (Boots, 2018).
Arm Title
Usual/standard care (control group)
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Partner in Balance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-efficacy
Description
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.
Time Frame
24 months
Title
Health-related quality-of-life
Description
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.
Time Frame
24 months
Title
Healthcare resource use
Description
Healthcare resource use of the informal caregivers and persons with dementia measured by the Resource Utilization in Dementia (RUD) (Wimo, 2013).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Depression and anxiety
Description
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.
Time Frame
12 months
Title
Quality of life (informal caregiver)
Description
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.
Time Frame
24 months
Title
Quality of life (person with dementia)
Description
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.
Time Frame
24 months
Title
Experienced burden of informal care
Description
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.
Time Frame
12 months
Title
Participant characteristics
Description
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)
Time Frame
baseline
Title
Cognitive status of the person with dementia as estimated by the informal caregiver
Description
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.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sander Osstyn, MSc
Phone
+31 43 388 1137
Email
s.osstyn@maastrichtuniversity.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Ron Handels, PhD
Phone
+31 43 38 81036
Email
ron.handels@maastrichtuniversity.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjolein de Vugt, professor
Organizational Affiliation
Maastricht University
Official's Role
Study Director
Facility Information:
Facility Name
Alzheimer Centrum Limburg
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6221
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sander Osstyn, MSc
Phone
+31 43 388 1137
Email
s.osstyn@maastrichtuniversity.nl

12. IPD Sharing Statement

Citations:
PubMed Identifier
26932438
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.
Results Reference
background
PubMed Identifier
27142676
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs