E-Tailored Pain Management Support for Dementia Family Caregivers: Feasibility of the PACE-app (NCT07032350) | Clinical Trial Compass
RecruitingNot Applicable
E-Tailored Pain Management Support for Dementia Family Caregivers: Feasibility of the PACE-app
United States60 participantsStarted 2025-05-22
Plain-language summary
The goal of this clinical trial is to test whether a web-based application called the Pain Control Enhancement App (PACE-app) can support family caregivers in managing pain for their care recipients with dementia. The main questions it aims to answer are:
Is it feasible and acceptable for family caregivers to use the PACE-app?
Does using the PACE-app improve caregiver self-efficacy in pain management, adherence to pain treatments, communication with care providers, well-being, and their care recipient's pain conditions?
Researchers will compare caregivers who use the PACE-app to those who continue with their usual care practices to see if the app leads to better outcomes for both caregivers and care recipients.
Participants will:
Be randomly assigned to either the PACE-app group or a usual-care control group
Complete online surveys at baseline, 1 month, and 2 months
If assigned to the PACE-app group:
Use the PACE-app for 1 month to receive tailored pain management strategies and tools, and record their care recipient's pain in a digital diary
Participate in an interview about their experience with the app
All participation activities can be done remotely or in person.
Who can participate
Age range
18 Years – 100 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.
Inclusion Criteria:
* Be a primary caregiver - (a family member, relative, or friend) of a person with dementia (or cognitive impairment) and chronic pain (lasting \>3 months)'
* Be responsible for managing the care recipient's pain and pain treatments (including interpreting verbal or non-verbal pain communication).
* Be age 18 - 100.
* Be able to read and speak English.
* Have regular access to an electronic device (tablet, laptop, or computer) with internet connectivity (for using the app and participating in data collection).
* Be accessible by phone or email to schedule meetings.
* Be willing to commit to the full study duration and protocol.
Exclusion Criteria:
* Currently participating in another research study that could interfere with this intervention.
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
Caregiver Self-Efficacy in Pain Management
Timeframe: Change from baseline to 1 month and 2 months