Developing and Evaluating a Digital Intervention Aiming to Support Informal Caregivers of People With Dementia

NCT07248241 | Not Yet Recruiting

• 2 other identifiers: CARE-DemJ.nr. 2024-0040
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dementia Caregiver; Digital Education Interventions

Keywords

Complex Intervention; Intervention Development; Intervention Adaptation; Feasibility; Co-Creation; Informal Caregivers; Support Tool; Digital Intervention; Dementia Caregiving

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (7)

• 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)

Other Outcomes (4)

• Change in caregiver burden from baseline to end of intervention

  Baseline and three months

• Change in mental wellbeing from baseline to end of intervention

  Baseline and three months

• Change in self-efficacy from baseline to end of intervention

  Baseline and three months

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants receive the CARE-Dem intervention

Behavioral: Digital support tool

Control group

NO INTERVENTION

Participants receive treatment as usual and can use available offers

Interventions

Digital support tool BEHAVIORAL

The CARE-Dem digital support tool offers a number of modules that participants must complete within three months.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult family members/relatives/other adult informal caregivers of a newly diagnosed person with dementia/a person with mild dementia

You may not qualify if:

• Unable to speak/understand Danish
• Incapable of collaborating about signing the informed consent

Sponsors & Collaborators

• Center for Clinical Research and Prevention: lead
• Copenhagen Municipality, Denmark: collaborator
• Municipality of Frederiksberg, Denmark: collaborator

Study Sites (1)

Department of Geriatrics and Palliation, University Hospital Bispebjerg and Frederiksberg ty Hospital

Frederiksberg, 2000, Denmark

Location

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Intervention group receives the intervention, control group receives TAU.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)