Med@HOME App for Medication Safety

Overseen By Gemma Warner

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must be taking: High-risk medications

Disqualifiers: Another child enrolled, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

336 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ryan Coller, MD, MPH

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for primary caregivers of children with complex medical needs who are under 17, use high-risk medications, and have had multiple healthcare visits in the past year. Caregivers must be over 18, speak English, consent to study rules, and commit to a 6-month participation.

Inclusion Criteria

Child with Medical Complexity: Provided assent, if appropriate

Primary Caregiver: Comfortable speaking and reading in English

Primary Caregiver: Willing to comply with all study procedures and available for the duration of the study

Exclusion Criteria

Failure to meet all inclusion criteria

Another child from the household is already enrolled in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments are conducted to evaluate medication administration accuracy and other secondary outcomes

1 week

1 visit (in-person)

Intervention

Participants are randomized into intervention (Meds@HOME) or control groups and use the app for medication management

6 months

Ongoing app usage with periodic assessments

Follow-up

Participants are monitored for medication administration accuracy and other outcomes post-intervention

4 weeks

Treatment Details

Interventions

• Meds@HOME Mobile App

Trial Overview The Meds@HOME mobile app is being tested to see if it helps caregivers safely give medication to Children with Medical Complexity (CMC). The study involves up to 456 participants (children and caregivers) using the app over six months.

Participant Groups

Group I: Meds@HOME Intervention Experimental Treatment 1 Intervention

Group II: Control Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+