Dementia CaregiverNCT07248241
Developing and Evaluating a Digital Intervention Aiming to Support Informal Caregivers of People With Dementia
A study testing Digital support tool in people with Dementia Caregiver and Digital Education Interventions, run by Center for Clinical Research and Prevention at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia Caregiver, Digital Education Interventions
- What is being tested?
- Digital support tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult family members/relatives/other adult informal caregivers of a newly diagnosed person with dementia/a person with mild dementia
Who cannot join
- Unable to speak/understand Danish
- Incapable of collaborating about signing the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Department of Geriatrics and Palliation, University Hospital Bispebjerg and Frederiksberg ty Hospital
Frederiksberg, 2000
Kristina D Munk, +4520304299, kristina.due.munk@regionh.dk
About this study
Official title: The Caregiver Education Resource for Dementia (CARE-Dem) Study: Developing and Evaluating a Digital Intervention to Support Informal Caregivers of People With Dementia
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:
Read more
- 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.
- Being tested
- Digital support tool
- Keywords
- Complex Intervention, Intervention Development, Intervention Adaptation, Feasibility, Co-Creation, Informal Caregivers, Support Tool, Digital Intervention, Dementia Caregiving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital support toolBehavioural
The CARE-Dem digital support tool offers a number of modules that participants must complete within three months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants receive the CARE-Dem intervention Receives: Behavioral: Digital support tool |
| Control group | No intervention | Participants receive treatment as usual and can use available offers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of participants enrolled divided by number of eligible individuals. Registered by a project nurse at the recruiting clinic
Measured: 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.
Measured: 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.
Measured: Three months (end of intervention)
Secondary outcomes (7)
Barriers to recruitment
Assessed through semi-structured, qualitative interviews with all professionals involved in re-cruitment and randomisation.
Measured: Baseline minus three months (start of enrolment) to baseline
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Three months (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia CaregiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group receives the intervention, control group receives TAU.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Clinical Research and Prevention
- Sponsor type
- Research network
- Collaborators
- Copenhagen Municipality, Denmark, Municipality of Frederiksberg, Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248241
- Sponsor's protocol ID
- CARE-Dem
- Other IDs
- J.nr. 2024-0040
- Status last verified
- Aug 2025
- First submitted
- 18 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Caregiver Education Resource for Dementia (CARE-Dem) Study: Developing and Evaluating a Digital Intervention to Support Informal Caregivers of People With Dementia
- ClinicalTrials.gov ID
- NCT07248241
- Acronym / sponsor ID
- CARE-Dem
- Keywords
- Complex Intervention, Intervention Development, Intervention Adaptation, Feasibility, Co-Creation, Informal Caregivers, Support Tool, Digital Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Center for Clinical Research and PreventionResearch network
- Collaborators
- Copenhagen Municipality, Denmark, Municipality of Frederiksberg, Denmark
- Study start
- Dec 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group receives the intervention, control group receives TAU.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Digital support toolParticipants receive the CARE-Dem intervention |
| Control group | No intervention | –Participants receive treatment as usual and can use available offers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult family members/relatives/other adult informal caregivers of a newly diagnosed person with dementia/a person with mild dementia
Key exclusion criteria (2 listed)
- Unable to speak/understand Danish
- Incapable of collaborating about signing the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital support toolThe CARE-Dem digital support tool offers a number of modules that participants must complete within three months. | Behavioural | Intervention group |
Primary outcome
Recruitment rate
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Barriers to recruitment
Time frame: Baseline minus three months (start of enrolment) to baseline
Completeness of survey data
Time frame: Three months (end of intervention)
Relevance of outcome measures to the target population
Time frame: Three months (end of intervention)
Intervention dose received
Time frame: Three months (end of intervention)
Extent to which the selected outcome measures demonstrate changes in the expected direction and magnitude
Time frame: Three months (end of intervention)
Experiences of randomisation procedure
Time frame: Baseline
Reasons for non-adherence and dropout
Time frame: Three months (end of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital support tool in people with Dementia Caregiver and Digital Education Interventions, run by Center for Clinical Research and Prevention at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise H Christensen, PhD (+45 23 82 23 59, elise.harder.christensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline minus three months (start of enrollment) to baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.