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| ID | Type | Description | Link |
|---|---|---|---|
| J.nr. 2024-0040 | Other Grant/Funding Number | Region Hovedstadens Forskningsfond til Sundhedsforskning |
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| Name | Class |
|---|---|
| Copenhagen Municipality, Denmark | OTHER_GOV |
| Municipality of Frederiksberg, Denmark | UNKNOWN |
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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:
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants receive the CARE-Dem intervention |
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| Control group | No Intervention | Participants receive treatment as usual and can use available offers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital support tool | Behavioral | The CARE-Dem digital support tool offers a number of modules that participants must complete within three months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Number of participants enrolled divided by number of eligible individuals. Registered by a project nurse at the recruiting clinic | Baseline minus three months (start of enrollment) to baseline |
| 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. | Three months (end of intervention) |
| 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. | Three months (end of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Barriers to recruitment | Assessed through semi-structured, qualitative interviews with all professionals involved in re-cruitment and randomisation. | Baseline minus three months (start of enrolment) to baseline |
| Completeness of survey data |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and three months |
Inclusion Criteria:
- Adult family members/relatives/other adult informal caregivers of a newly diagnosed person with dementia/a person with mild dementia
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elise H Christensen, PhD | Contact | +45 23 82 23 59 | elise.harder.christensen@regionh.dk | |
| Julie C Grew, PhD | Contact | +4526285755 | julie.grew@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Geriatrics and Palliation, University Hospital Bispebjerg and Frederiksberg ty Hospital | Frederiksberg | 2000 | Denmark |
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Intervention group receives the intervention, control group receives TAU.
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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.
| Three months (end of intervention) |
| Relevance of outcome measures to the target population | Assessed through semi-structured, qualitative interviews with all participants in the intervention group. | Three months (end of intervention) |
| 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. | Three months (end of intervention) |
| Extent to which the selected outcome measures demonstrate changes in the expected direction and magnitude | Evaluated by comparing observed mean change scores from baseline to end of intervention with effect sizes reported in previous studies of digital interventions for informal caregivers of people with dementia. Feasibility will be considered acceptable if observed changes in the intervention group from baseline to end of intervention are in the expected direction and within the range of small-to-moderate effects (Cohen's d ≥ 0.20), consistent with similar studies of digital interventions for informal caregivers of people with dementia. | Three months (end of intervention) |
| Experiences of randomisation procedure | Assessed via short interviews with recruiting nurses who collect accounts from participants in the intervention group and participants in the control group. | Baseline |
| Reasons for non-adherence and dropout | Assessed through interviews with participants who do not complete the intervention within the designated three months. We aim to interview as many as possible among participants who drop out or do not complete the intervention. | Three months (end of intervention) |
| 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. | Baseline and three months |
| 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. | Baseline and three months |
| 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. | Three months (end of intervention) |