Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 12/5/23 | Other Identifier | UW Madison | |
| A536771 | Other Identifier | UW Madison | |
| Pediatric Hospitalist | Other Identifier | UW Madison | |
| R18HS028409 | U.S. AHRQ Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
Not provided
Not provided
Not provided
Not provided
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.
The investigators will test the hypothesis that Meds@HOME use improves medication administration accuracy for caregivers by conducting a 6-month randomized controlled trial with caregivers of CMC.
The study population will consist of 1) CMC who are prescribed at least one scheduled high-risk medication and receive care at UW Health, and 2) their caregivers. The study distinguishes between three types of caregivers: 1) primary caregivers (child's parent or legal guardian), 2) secondary caregivers (up to 2 individuals who regularly provide care for the child and who complete study surveys), and 3) other caregivers (invited to use the app but not complete study surveys). CMC and their primary caregiver participants will be randomized into intervention (Meds@HOME, "I") or control ("C") groups. Assessments at baseline and 6 months post-enrollment will assess the primary endpoint (medication administration accuracy), secondary outcomes, and Meds@HOME use by primary and secondary caregivers.
Participant accrual will occur over 12 months at one site and participants can expect to be on study for 6 months.
The primary study objective is to evaluate the effectiveness of Meds@HOME on primary caregiver medication administration accuracy.
The secondary objectives are to evaluate Meds@HOME's:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meds@HOME Intervention | Experimental |
| |
| Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Med@HOME Mobile App | Other | Meds@HOME is a software application designed for use on a personal mobile device. The app allows primary caregiver to create routines where they can detail how to perform the routine, start date and time, and frequency (daily, weekly, monthly). Optional push notifications can be set so that users are alerted to an upcoming routine. Only primary caregivers can create, edit, and delete routines. All caregivers can check off on routines and receive notifications. Caregivers can also post notes related to routines or events. App enables an inventory of caregiver troubleshooting strategies and inventory reminders. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of Participants Demonstrating Medication Administration Accuracy | Rate of medication administration accuracy, measured dichotomously as correct identification of each of the following for a randomly selected high risk medication: indication, formulation, dose, frequency, and route after 6-months | baseline (before randomization), 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of Participants Demonstrating Medication Administration Accuracy among Secondary Caregivers | Rate of medication administration accuracy, measured as in the primary outcome, amongst secondary caregivers after 6-months | baseline (before randomization), 6 months |
| Count of University of Wisconsin (UW) hospital encounters during study period with Adverse Drug Event (ADE) codes |
Not provided
Inclusion Criteria (Child with Medical Complexity):
Inclusion Criteria (Primary Caregiver):
Inclusion Criteria (Secondary Caregiver):
Inclusion Criteria (Other Caregivers - Treatment Group only):
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ryan Coller, MD, MPH | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison, UW Health | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39250787 | Derived | Werner NE, Morgen M, Kooiman S, Jolliff A, Warner G, Feinstein J, Chui M, Katz B, Storhoff B, Sodergren K, Coller R. Effectiveness of a Mobile App (Meds@HOME) to Improve Medication Safety for Children With Medical Complexity: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 9;13:e60621. doi: 10.2196/60621. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 6, 2026 | |
| Reset | Jun 3, 2026 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 30, 2023 | May 20, 2025 | ICF_000.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 6, 2026 | Jun 3, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| up to 6 months |
| Count of UW Emergency Department (ED) encounters during study period with ADE codes | up to 6 months |
| Mean parent-reported medication adherence using the Adherence to Refills and Medications Scale (ARMS) | ARMS is a 12-item instrument scored from 12 to 34, with lower scores indicating better adherence. | up to 6 months |
| Mean FCAT (Family Caregiver Activation in Transition) Score for 5 medication-specific items | FCAT Score for 5 medication-specific items - composite and individual items will be reported after 6-months. Scoring is from 1-5 with higher scores indicating fewer challenges to care. | up to 6 months |
| Parent-Reported Medication Confidence | To evaluate Meds@HOME's effect on parent-reported medication confidence. Mean composite score after 6-months. Medication Confidence is measured on a 7-item survey scored on a 5 point likert scale for a total possible range of scores from 7-35 where lower scores indicate increased medication confidence. | up to 6 months |
| Parent-Reported Medication Understanding | To evaluate Meds@HOME's effect on parent-reported medication understanding. Mean composite score after 6-months. Medication Understanding is measured on a 5-item survey scored on a 5 point likert scale for a total possible range of scores from 5-25 where lower scores indicate increased medication understanding. | up to 6 months |
| Count of hospital encounters and hospital days during study period | Count of hospital encounters and hospital days during study period. | up to 6 months |
| Count of ED encounters during study period | Count of ED encounters during study period. | up to 6 months |
| Count of deaths during the study period | Count of deaths during the study period | up to 6 months |
| Rate of Medication Adherence for Individual Components (indication, formulation, dose, frequency, and route) | Rate of individual components each measured dichotomously (indication, formulation, dose, frequency, and route). | up to 6 months |
| Mean Number of Individual Components of Medication Adherence Correct | Mean number of individual components correct (from 0 components to all 5: indication, formulation, dose, frequency, route). | up to 6 months |