Dementia, MildNCT05450146
Trial-based Effectiveness and Cost-effectiveness of the Partner in Balance Intervention
A study testing Partner in Balance in people with Dementia, Mild, run by Maastricht University at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mild
- What is being tested?
- Partner in Balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2022to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Alzheimer Centrum Limburg
Maastricht, Limburg, 6221
Sander Osstyn, MSc, +31 43 388 1137, s.osstyn@maastrichtuniversity.nl
About this study
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
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.
Read more
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
- Being tested
- Partner in Balance
- Keywords
- early-stage dementia, informal caregiver, informal care
- Medical subject headings
- Dementia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner in BalanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 24 months
Secondary outcomes (6)
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.
Measured: 12 months
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 12 months
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)
Measured: baseline
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Apr 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dementia, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam, ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Marjolein de Vugt, professor, Study director, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450146
- Sponsor's protocol ID
- METC 2021-2955
- Other IDs
- 80-85200-98-21039
- Status last verified
- Jan 2024
- First submitted
- 4 Jul 2022
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26932438Boots 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.
PubMed 27142676Osstyn 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.
PubMed 37349828
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05450146
- Acronym / sponsor ID
- METC 2021-2955
- Conditions
- Dementia, Mild
- Keywords
- early-stage dementia, informal caregiver, informal care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- VU University of Amsterdam, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partner in Balance (intervention group) | Experimental | Other: Partner in BalanceInformal caregivers assigned to the intervention group will receive the 8-week online selfmanagement program "Partner in Balance" (Boots, 2018). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partner in BalanceThe "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. | Other | Partner in Balance (intervention group) |
Primary outcome
Self-efficacy
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
Healthcare resource use of the informal caregivers and persons with dementia measured by the Resource Utilization in Dementia (RUD) (Wimo, 2013).
6 secondary outcomes
Depression and anxiety
Time frame: 12 months
Quality of life (informal caregiver)
Time frame: 24 months
Quality of life (person with dementia)
Time frame: 24 months
Experienced burden of informal care
Time frame: 12 months
Participant characteristics
Time frame: baseline
Cognitive status of the person with dementia as estimated by the informal caregiver
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 26932438Boots 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.
- Background: PubMed 27142676Boots 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.
- Derived from this study: PubMed 37349828Osstyn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjolein de Vugt, professor study director
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partner in Balance in people with Dementia, Mild, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sander Osstyn, MSc (+31 43 388 1137, s.osstyn@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05450146, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.