Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moder… (NCT04944420) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
400 participantsStarted 2026-02-15
Plain-language summary
Health enSuite Caregivers is an e-health program designed to meet some of the most common needs of caregivers of persons with dementia, including information about dementia and dementia care, caregivers' emotional health, formal or informal help received from others. It also recommends specific strategies to promote wellbeing and provides tools to help caregivers implement these strategies in their everyday lives. Health enSuite Caregivers is available online and as a smartphone app. Its development was informed by reviews of caregivers' needs and existing commercially available apps F. A systematic search of commercially available smartphone applications for caregivers found that many apps did not consider each caregiver's unique needs and were limited to psychoeducational content (no tools for self-management). Furthermore, most existing programs have not been rigorously tested or lack evidence to support their effectiveness.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
To be eligible for this trial, participants will have to satisfy the following criteria:
1. The participant is 18 years or older.
2. The participant has regular access to an internet connected device (e.g., smartphone, tablet, or computer).
3. The participant is a caregiver of a person with moderate dementia.
4. The participant provides a least one hour of care per week.
5. The participant is experiencing distress associated with caregiving (score DQ5 \>= 11).
Rational:
Health enSuite Caregivers program being tested in this trial requires the use of an internet connected device. Health enSuite Caregivers can be downloaded as a mobile application for use on a smartphone or tablet, or it can be accessed through the web browser on an electronic device with an internet connection. People who do not have regular access to an internet connected device are unlikely to benefit from Health enSuite Caregivers, and therefore they will be excluded.
Health enSuite Caregivers is designed to help primary caregivers of persons with moderate dementia. Therefore, the eligibility screening questionnaire includes items to assess dementia severity. To ensure that the participants has ongoing caregiving duties, they must self-report providing at least one hour of care per week. There is no clear consensus on the number of hours of care that all primary caregivers provide. Reports from the Canadian Institute for Health Informatics estimate that on average informal caregivers of persons with dem…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Carer wellbeing
Timeframe: Baseline assessment, 2 months post randomization, 5 months post randomization