Eerder Erbij: Een Vroege Ondersteuning Voor Mensen Met Dementie en Hun Mantelzorgers. The Path Towards Offering Timely Support for People With Dementia and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Caregiver Self-efficacy Scale (CSES)
研究概览
简要总结
INTRODUCTION AND RATIONALE
It has been estimated that at least 50% of the home living persons with dementia in the Netherlands receive little or no formal care and support (Zorgstandaard Dementie, 2013). Reasons why persons with dementia and their informal caregivers receive no formal care vary, include absence of diagnosis, denial of illness, embarrassment or the complexity of the care and referral system. A common concern among health care professionals is that by the time the person with dementia or informal caregiver do seek or receive formal care it may be too late. The difficulties at home may already be so severe that there is little that community-based care can do and admission to residential care may follow soon after. Appropriate support at an earlier stage may prevent more serious difficulties and postpone admission to residential care. Therefore, health care professionals are looking for strategies to reach persons with dementia and caregivers in an earlier stage of dementia and encourage them to accept some form of help or support. The rationale of this study is to investigate how persons living with dementia and their close others can be encouraged to accept support and whether support at an early stage is effective in preventing severe deterioration in wellbeing, behavioural difficulties and high care costs later on.
OBJECTIVES
- Estimate the effect of EE on caregiver self-efficacy compared to usual care
- Estimate the effect of EE on the total care costs of caregiver and person with dementia compared to usual care
- Estimate the cost-effectiveness and cost-utility of EE compared to usual care
- Perform a process evaluation to monitor delivery of EE and experiences of persons with dementia, caregivers and care professionals
- Explore treatment responsiveness of EE in terms of self-efficacy and quality of life
STUDY DESIGN
Pragmatic, cluster randomised controlled trial.
STUDY POPULATION
Informal caregivers and people with early-stage dementia, who are community dwelling and receive little or no dementia-related formal ADL care.
INTERVENTION
The intervention (Eerder Erbij, EE) is a person-centred, manual-based intervention consisting of education, information and a support group.
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; take place at baseline, 3, 6, and 12 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Informal caregivers can be spouses, relatives, or friends who care for and support the person with dementia without pay. If the caregiver does not live with the person with dementia, they have to visit the person with dementia at least 3 times a week to be eligible for the study.
- •The person with dementia must be living at home cared for by the caregiver.
- •The person with dementia should have a diagnosis of dementia or experience severe cognitive impairments suggesting dementia. Type of dementia is not an inclusion criterion.
- •The person with dementia is not yet receiving formal care related to personal activities of daily living on account of his or her dementia more than once a week (defined by receiving assistance from a paid worker by e.g., health or social care professional as help with dressing/undressing; washing/bathing/showering; toileting; feeding/drinking; or taking medication).
排除标准
- •Main exclusion criteria for both the caregiver and the person with dementia will be major mental or physical illness, such as major depression or stroke, that would affect their ability to participate in this study.
- •Person with dementia or informal caregiver is participating in another intervention or similar support program.
- •Dementia is caused by human immunodeficiency virus (HIV), acquired brain impairment, Down syndrome, chorea associated with Huntington's disease, or alcohol abuse.
- •Inability to give informed consent will also be an exclusion criterion.
- •Informal caregiver is younger than 18 years old.
结局指标
主要结局
Caregiver Self-efficacy Scale (CSES)
时间窗: 12 months
The self-efficacy of informal caregivers measured by the Caregiver Self-efficacy Scale (CSES). This domain contains five items that are scored self-rated from 1 (not at all certain) to 10 (very certain) with higher scores indicating better outcomes.
次要结局
- HADS(12 months)
- ICECAP-O(12 months)
- TOPICS-MDS(12 months)
- QOL-AD(12 months)
- EDIZ(12 months)
- EQ-5D-5L(12 months)
- QDRS(12 months)
- RUD(12 months)
研究者
Sanne Balvert
Principal Investigator
VU University of Amsterdam