Technology-Based Intervention Usability and Pilot Testing (NCT07146581) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Technology-Based Intervention Usability and Pilot Testing
United States40 participantsStarted 2025-10-18
Plain-language summary
This research project has three main goals:
(1) To create a new screening tool that helps primary care doctors spot signs of neglect in older adults with dementia. (2) To design a support program that can be delivered both in person and through a mobile app on Android phones. (3) To run a clinical trial with three groups of participants to find out how effective the screening tool is on its own, and how effective it is when combined with the support program-compared to standard care.
This current phase of the project focuses on parts of goals 1 and 2, as described below.
Who can participate
Age range
21 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:
* 21 years old or older
* Provides care for a patient at the Center on Aging who meets the following criteria:
* Patient is at least 65 years old
* Patient has diagnosed dementia
* Patient requires assistance with at least 1 ADL
* Self-identifies as primary informal caregiver for an older adult
* Provides at least 8 hours per week of direct care (may include logistics, oversight, observation, as well as hands-on care, but must include at least some in-person assistance)
* Can read and speak English at a 6th grade level or above
* Not blind or deaf
* No active plan to disengage from providing care to the older adult within the next year
* Ability to travel to the COA or CABR for study activities and/or attend study session(s) virtually through Zoom on their personal device
Exclusion Criteria:
* Non-fluent English speaker
* Hired caregiver
* Provides care for a patient in hospice care
* Too ill or weak to complete the interviews (per the interviewer)
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
Perceived system feasibility, acceptability, and usability of the SIRENS intervention as measured by the Mean Difference in Score of the Program Evaluation Questionnaire.
Timeframe: 1 week post-intervention
2
Perceived system feasibility, acceptability, and usability of the SIRENS intervention as measured by a qualitative interview assessment
Timeframe: 1-week post intervention
Trial details
NCT IDNCT07146581
SponsorWeill Medical College of Cornell University