NCT04944420 · NOT YET RECRUITING
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
This trial is testing a smartphone and web app called Health enSuite Caregivers, designed to reduce burnout and emotional distress in people who care for someone with moderate dementia. The app offers education, emotional support tools, and self-management strategies. This is a Phase NA trial — meaning it is evaluating a behavioral tool rather than a drug, focused on whether the app genuinely helps caregivers feel and cope better.
Eligibility criteria
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 dementia provide 26 hours of care per week (3). One hour per week was selected as a minimum threshold to exclude people with very limited caregiving responsibilities. Health enSuite Caregivers is intended to help caregivers who are experiencing some degree of distress. Participants must also score above the cut-off score (>=11) for distress on the DQ-5 (18), a population distress screening measure.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-01-27