Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05816590
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-03-16
Brief Title:
MedsHOME App to Support Medication Safety
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
MedsHOME - Improving Medication Safety for Medically Complex Children With mHealth Across Caregiving Networks R18 Aim 2
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study determines whether the mHealth intervention MedsHOME 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
Detailed Description:
The investigators will test the hypothesis that MedsHOME 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 childs 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 MedsHOME I or control C groups Assessments at baseline and 6 months post-enrollment will assess the primary endpoint medication administration accuracy secondary outcomes and MedsHOME 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 MedsHOME on primary caregiver medication administration accuracy
The secondary objectives are to evaluate MedsHOMEs
effectiveness on secondary caregiver medication administration accuracy
effect on adverse drug event ADE hospital use
effect on adverse drug event ED use
effect on parent-reported medication adherence
effect on parent-reported medication activation
effect on parent-reported medication confidence
effect on parent-reported medication understanding
effect on all-cause hospital use
effect on all-cause ED use
effect on mortality
effect on the primary outcome measured as 5 individual components
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 childs 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 MedsHOME I or control C groups Assessments at baseline and 6 months post-enrollment will assess the primary endpoint medication administration accuracy secondary outcomes and MedsHOME 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 MedsHOME on primary caregiver medication administration accuracy
The secondary objectives are to evaluate MedsHOMEs
effectiveness on secondary caregiver medication administration accuracy
effect on adverse drug event ADE hospital use
effect on adverse drug event ED use
effect on parent-reported medication adherence
effect on parent-reported medication activation
effect on parent-reported medication confidence
effect on parent-reported medication understanding
effect on all-cause hospital use
effect on all-cause ED use
effect on mortality
effect on the primary outcome measured as 5 individual components
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol Version 2723 | OTHER | None | None |
| A536771 | OTHER | None | None |
| Pediatric Hospitalist | OTHER | None | None |
| R18HS028409 | AHRQ | UW Madison | httpsreporternihgovquickSearchR18HS028409 |