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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Dementia, Mild

Intervention / Treatment
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* Other: Partner in Balance


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partner in Balance (intervention group)<br>Informal caregivers assigned to the intervention group will receive the 8-week online selfmanagement program Partner in Balance (Boots, 2018). | Other: Partner in Balance<br>* 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.<br>|
| No Intervention: Usual/standard care (control group)<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early-stage dementia, informal caregiver, informal care