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

NCT ID: NCT07248241

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

Participants receive the CARE-Dem intervention

Group Type: EXPERIMENTAL

Digital support tool

Intervention Type: BEHAVIORAL

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

Control group

Participants receive treatment as usual and can use available offers

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Digital support tool

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Copenhagen Municipality, Denmark

OTHER_GOV

Sponsor Role: collaborator

Municipality of Frederiksberg, Denmark

UNKNOWN

Sponsor Role: collaborator

Center for Clinical Research and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Frederiksberg, , Denmark

Countries

Denmark

Central Contacts

Elise H Christensen, PhD

Role: CONTACT

elise.harder.christensen@regionh.dk

+45 23 82 23 59

Julie C Grew, PhD

Role: CONTACT

julie.grew@regionh.dk

+4526285755

Facility Contacts

Kristina D Munk

Role: primary

kristina.due.munk@regionh.dk

+4520304299

Other Identifiers

J.nr. 2024-0040

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CARE-Dem

Identifier Type: -

Identifier Source: org_study_id