Clinical Trial Finder

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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05450146
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Maastricht University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Marjolein de Vugt, professor
Principal Investigator Affiliation Maastricht University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Dementia, Mild
Arms & Interventions

Arms

Experimental: Partner in Balance (intervention group)

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

No Intervention: Usual/standard care (control group)

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Alzheimer Centrum Limburg, Maastricht 2751283, Limburg 2751596, Netherlands

Status

Recruiting

Address

Alzheimer Centrum Limburg

Maastricht 2751283, Limburg 2751596, 6221

Site Contact

Sander Osstyn, MSc

[email protected]

+31 43 388 1137

Powered By

Stay Informed & Connected