Meds@HOME App to Support Medication Safety (NCT05816590) | Clinical Trial Compass
CompletedNot Applicable
Meds@HOME App to Support Medication Safety
United States336 participantsStarted 2023-12-11
Plain-language summary
This study determines whether the mHealth intervention, Meds@HOME, helps caregivers improve medication administration to Children with Medical Complexity (CMC) who use high-risk medications. A total of 152 primary caregivers, 152 children, and up to 304 secondary caregivers will be recruited and can expect to be on study for up to 6 months.
Who can participate
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 (Child with Medical Complexity):
* less than or equal to 17 years of age at start of study
* In the last 12 months, child has had at least two or more encounters (in-person or telehealth clinic visit, ED visit, or hospital admission) in the UWHC/AFCH system
* Child has 2 or more different complex chronic conditions
* Child has at least 1 active, outpatient prescription for a scheduled high-risk medication
* Provided assent, if appropriate
Inclusion Criteria (Primary Caregiver):
* Provided written informed consent form as the child's parent or legal guardian
* Willing to comply with all study procedures and available for the duration of the study
* At least 18 years of age
* Comfortable speaking and reading in English
* Self-identifies as a primary caregiver of a study-eligible CMC
* Currently provides care on an ongoing basis to the study-eligible CMC. Child may not be housed in a skilled nursing facility, an acute care or transitional facility, a rehabilitative hospital, or in a medical group home
* Has iOS or Android mobile device (smartphone, tablet) with a phone plan that includes daily Wi-Fi service and data
Inclusion Criteria (Secondary Caregiver):
* Has been identified as a "secondary caregiver" by the primary caregiver
* Provided informed consent
* Willing to comply with all study procedures and be available for the duration of the study
* At least 18 years of age
* Comfortable speaking and reading in English
* Currently provides care on an ong…
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
Change in Percentage of Participants Demonstrating Medication Administration Accuracy