Developing and Evaluating a Digital Intervention Aiming to Support Informal Caregivers of People With Dementia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital support tool.
- Who it may be relevant to
- Registry conditions: Dementia Caregiver, Digital Education Interventions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Behavioral Digital support tool
The CARE-Dem digital support tool offers a number of modules that participants must complete within three months.
Primary outcome measures
- Recruitment rate [Time frame: Baseline minus three months (start of enrollment) to baseline]
- Response rate to survey [Time frame: Three months (end of intervention)]
- User experiences with intervention [Time frame: Three months (end of intervention)]
Secondary outcome measures (7)
- 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Denmark · 1 center
- Department of Geriatrics and Palliation, University Hospital Bispebjerg and Frederiksberg — Frederiksberg
Identifiers
NCT: NCT07248241 · CARE-Dem · J.nr. 2024-0040