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

Официальное название

The Caregiver Education Resource for Dementia (CARE-Dem) Study: Developing and Evaluating a Digital Intervention to Support Informal Caregivers of People With Dementia

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Recruitment rate [Срок оценки: Baseline minus three months (start of enrollment) to baseline]
• Response rate to survey [Срок оценки: Three months (end of intervention)]
• User experiences with intervention [Срок оценки: Three months (end of intervention)]

Вторичные конечные точки (7)

• Barriers to recruitment [Срок оценки: Baseline minus three months (start of enrolment) to baseline]
• Completeness of survey data [Срок оценки: Three months (end of intervention)]
• Relevance of outcome measures to the target population [Срок оценки: Three months (end of intervention)]
• Intervention dose received [Срок оценки: Three months (end of intervention)]
• Extent to which the selected outcome measures demonstrate changes in the expected direction and magnitude [Срок оценки: Three months (end of intervention)]
• Experiences of randomisation procedure [Срок оценки: Baseline]
• Reasons for non-adherence and dropout [Срок оценки: Three months (end of intervention)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Дания · 1 центр

• Department of Geriatrics and Palliation, University Hospital Bispebjerg and Frederiksberg — Frederiksberg

Идентификаторы

NCT: NCT07248241 · CARE-Dem · J.nr. 2024-0040

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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