NCT06672042

Parental Adherence of a Mobile Application

Parental AdheRence of an Asynchronous Mobile hEalth Application for Children With Medical TEchnologies Using a Randomized Trial of Outpatient Nursing Care Models (PARAMETER)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

Summary

This is a single-site, stratified grouping parallel- randomized control trial design comparing 30-day all-cause readmission rates and parent experience with two groups of pediatric participants.

Detailed description

This proposal's overall objective is to evaluate the effectiveness of an enterprise-level outpatient nursing care model with an asynchronous mobile health platform for parents of children with medical complexity (CMC) age 0-3 years to communicate with their child's healthcare team via remote patient monitoring (RPM). The researchers will evaluate the efficacy of a proactive nursing care model on 30-day readmissions (Aim 1), parental experience and managing their child's care at home (Aim 2), and healthcare team engagement frequency with a proactive outpatient nursing care model necessary to achieve adoption into outpatient models of care (Aim 3).

Conditions

• Pediatrics
• Medically Complex
• Children With Medical Complexity (CMC)
• Nursing

Interventions

Type	Name	Description
DEVICE	CHAMP App	CHAMP® App is a proprietary, downloadable, mobile Software Application and software platform designed and developed by the Children's Mercy Hospital of Kansas City (CMH), that permits parents and caregivers to transmit to the care team data to permit remote monitoring of the patient's condition. The parent or caregiver enters into the CHAMP App data including vital signs, intake and output, video, and images of patients (collectively, "CHAMP® Data"), which operates on computers, mobile devices, and handheld computers. The CHAMP® App is intended to be used in the clinical care of pediatric patients in the home setting that are followed by specialty health care teams to improve patient self-management through the use of asynchronous data. Videos and data related to the patient are entered by the parent and sent electronically to the Clinical Care Team as recommended by the clinical team.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2024-11-04
• Last updated: 2025-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study