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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Healthcare resource use
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Partner in Balance (Other)
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.
结局指标
主要结局
Healthcare resource use
时间窗: 24 months
Healthcare resource use of the informal caregivers and persons with dementia measured by the Resource Utilization in Dementia (RUD) (Wimo, 2013).
Self-efficacy
时间窗: 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
时间窗: 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.
次要结局
- Quality of life (person with dementia)(24 months)
- Participant characteristics(baseline)
- Depression and anxiety(12 months)
- Quality of life (informal caregiver)(24 months)
- Experienced burden of informal care(12 months)
- Cognitive status of the person with dementia as estimated by the informal caregiver(baseline)