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.
None
Unable to speak/understand Danish
Incapable of collaborating about signing the informed consent
Parallel
Digital support tool
BehavioralThe CARE-Dem digital support tool offers a number of modules that participants must complete within three months.
Recruitment rate
Number of participants enrolled divided by number of eligible individuals. Registered by a project nurse at the recruiting clinic
Response rate to survey
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
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.
Barriers to recruitment
Assessed through semi-structured, qualitative interviews with all professionals involved in re-cruitment and randomisation.
Completeness of survey data
Number of completed survey items at follow-up divided by total number of items. Only surveys filled in at baseline and end of intervention are counted. Assessed in the REDCap database where all survey data are gathered.
Relevance of outcome measures to the target population
Assessed through semi-structured, qualitative interviews with all participants in the intervention group.
Intervention dose received
Proportion of intervention components completed by each participant within three months. Collected via participant logs, where all interaction with the intervention will be documented by participants in the intervention group.
Change in caregiver burden from baseline to end of intervention
Measured with the Zarit Burden Interview (ZBI), a 22-item questionnaire including four aspects of caregiver burden: personal strain, role strain, impact on social life, and impact on personal health. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always) with total scores ranging from 0 to 88.
Change in mental wellbeing from baseline to end of intervention
Measured with the World Health Organization 5-Item Well-Being Index (WHO-5), a 5-item ques-tionnaire concerning feelings about everyday life in the previous two weeks. Items are rated on a 6-point Likert scale ranging from 0 (at no time) to 5 (all the time). The raw score ranges from 0 to 25 and is converted to a percentage score from 0 to 100.
Change in self-efficacy from baseline to end of intervention
Measured with the General Self-Efficacy Scale (GSES), a 10-item questionnaire assessing per-ceived ability to cope with challenging and demanding situations. Items are rated on a 4-point Lik-ert scale from 1 (not at all true) to 4 (exactly true) with total scores ranging from 10 to 40.
Acquired knowledge and benefit of the intervention
Participants' experiences of knowledge and benefits acquired from using the intervention, particularly regarding impact on the quality of their relation to the person with dementia, experiences of being able to accept the situation, and feelings of being capable of managing their caregiving role. Assessed through qualitative interviews with participants in the intervention group.
Click on the lead sponsor to view all of their trials.
Center for Clinical Research and Prevention
Lead sponsor
Copenhagen Municipality, Denmark
Collaborator
Municipality of Frederiksberg, Denmark
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
