The Caregiver Education Resource for Dementia (CARE-Dem) Study: Developing and Evaluating a Digital Intervention to Support Informal Caregivers of People With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this feasibility trial is to test the acceptability and feasibility of a new digital education pro-gram, the Caregiver Education Resource for Dementia (CARE-Dem). This is a behavioral (non-medical) intervention, designed to support informal caregivers of people with dementia. The primary purpose is to explore whether this program can help improve wellbeing and reduce burden among informal caregivers. The study focuses on adult caregivers, such as spouses, partners, relatives, or close friends of people recently diagnosed with dementia or living with mild dementia.
The main questions it aims to answer are:
- Is it possible to recruit and retain caregivers to participate in this type of digital intervention?
- Do participants find the program relevant, useful, and acceptable? Are the study procedures and outcome measures (such as questionnaires) suitable and manage-able for the participants?
- Does the intervention show preliminary signs of reducing caregiver burden and improving care-givers' wellbeing, knowledge, quality of relationship with the person with dementia, ability to ac-cept the situation, and feelings of being capable of managing their caregiving role? Researchers will compare caregivers who receive the CARE-Dem program with a control group who are offered the usual municipal information sessions. This allows us to see whether the digital pro-gram is feasible and whether it shows signs of effect compared with standard practice.
Participants in the intervention group will be asked to:
• Use the CARE-Dem digital platform over a three-month period.
The platform includes three modules:
Module 1: Understanding dementia and medical treatment options Module 2: Everyday life and communication with a person with dementia Module 3: Legal and practical matters, and information on support available in the community
- Engage with a mix of learning materials such as short videos, fact sheets, interactive activities, guides, and links to further resources
- Complete questionnaires at baseline and after 3 months to measure caregiver burden, wellbeing, and self-efficacy
- Take part in qualitative interviews about their experiences with the program, including usability, satisfaction, acquired knowledge, benefits, and suggestions for improvement.
Participants in the control group will receive treatment as usual. They will be offered to take part in existing information sessions provided by the municipalities, but attendance is optional. Researchers will record whether or not they attend, in order to compare results across subgroups.
This feasibility trial will help determine whether it is possible to run a larger evaluation of the CARE-Dem program in the future. If successful, the program could provide flexible and accessible support to the many caregivers of people with dementia, reaching those who cannot attend traditional in-person sessions.
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
- •- Adult family members/relatives/other adult informal caregivers of a newly diagnosed person with dementia/a person with mild dementia
排除标准
- •Unable to speak/understand Danish
- •Incapable of collaborating about signing the informed consent
结局指标
主要结局
Recruitment rate
时间窗: Baseline minus three months (start of enrollment) to baseline
Number of participants enrolled divided by number of eligible individuals. Registered by a project nurse at the recruiting clinic
Response rate to survey
时间窗: Three months (end of intervention)
Number of full surveys returned at follow-up divided by total number of participants. Assessed in the REDCap database where all survey data are gathered.
User experiences with intervention
时间窗: Three months (end of intervention)
Satisfaction, relevance, perceived value, ease of use, key barriers and facilitators for use, suggestions for improvement of the CARE-Dem. Assessed through semi-structured, qualitative interviews with participants in the intervention group.
User experiences with intervention
时间窗: Three months (end of intervention)
Satisfaction, relevance, perceived value, ease of use, key barriers and facilitators for use, suggestions for improvement of the CARE-Dem. Assessed through semi-structured, qualitative interviews with participants in the intervention group.
Response rate to survey
时间窗: Three months (end of intervention)
Number of full surveys returned at follow-up divided by total number of participants. Assessed in the REDCap database where all survey data are gathered.
Recruitment rate
时间窗: Baseline minus three months (start of enrollment) to baseline
Number of participants enrolled divided by number of eligible individuals. Registered by a project nurse at the recruiting clinic
次要结局
- Barriers to recruitment(Baseline minus three months (start of enrolment) to baseline)
- Completeness of survey data(Three months (end of intervention))
- Relevance of outcome measures to the target population(Three months (end of intervention))
- Extent to which the selected outcome measures demonstrate changes in the expected direction and magnitude(Three months (end of intervention))
- Experiences of randomisation procedure(Baseline)
- Reasons for non-adherence and dropout(Three months (end of intervention))
- Barriers to recruitment(Baseline minus three months (start of enrolment) to baseline)
- Completeness of survey data(Three months (end of intervention))
- Relevance of outcome measures to the target population(Three months (end of intervention))
- Intervention dose received(Three months (end of intervention))
- Extent to which the selected outcome measures demonstrate changes in the expected direction and magnitude(Three months (end of intervention))
- Experiences of randomisation procedure(Baseline)
- Reasons for non-adherence and dropout(Three months (end of intervention))