NCT04470193

Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 1 Year – 20 Years
• Healthy volunteers: Not accepted

Summary

The investigators have developed a tool to facilitate self-management for children with medical complexity (complex, multisystem chronic diseases) called MyChildCMC (My Child's Complex Medical Condition). MyChildCMC is an online, phone application (app) that engages parents daily in ongoing monitoring of common, crosscutting acute symptoms, including respiratory distress, inadequate feeding/fluid intake, fever, altered mental status, pain, and seizure status. The MyChildCMC app also guides parents to recognize early warning signs for health deteriorations to avoid acute events (i.e., ED visits and/or hospitalizations). Parent comments during the development of the MyChildCMC application revealed that the tool had potential in helping them manage their child's chronic conditions. This study will be the first to explore if online home monitoring using online technology is feasible, scalable, and can lead to improved CMC outcomes. This pilot trial for the MyChildCMC app was designed to determine preliminary impact by comparing outcomes (child QOL, child emergency department and hospital admissions, and parent/caregiver satisfaction with care) between the intervention and control groups. If successful, our approach will be a model for improving CMC care and reducing costs for families and children with medical complexity. Future MyChildCMC trials will integrate care coordination and a more robust alert system to help facilitate care and follow-up for patients.

Detailed description

Aim: Investigators will assess the impact of the MyChildCMC app by comparing the following outcomes for the child and caregiver: 1. Child Quality of Life (QOL) 2. Child Emergency Department (ED) and hospital admissions 3. Number of hospital days 4. Parent/Caregiver satisfaction with care

Conditions

• Children With Medical Complexity

Interventions

Type	Name	Description
OTHER	MyChildCMC app	Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time.

Timeline

• Start date: 2019-06-10
• Primary completion: 2020-03-19
• Completion: 2020-03-19
• First posted: 2020-07-14
• Last updated: 2024-10-04
• Results posted: 2024-10-04

Locations

1 site across 1 country: United States