MyChildCMC app to help families monitor children with medical complexity
A Novel mHealth Intervention to Improve Outcomes of Children With Medical Complexity
This study tests whether a smartphone/tablet app used by caregivers can help spot early health problems in children with medical complexity and reduce emergency or hospital visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT06883045 on ClinicalTrials.gov |
What this trial studies
The trial will enroll children ages 1–18 who meet an operational definition of medical complexity and their caregivers at two comprehensive care clinics. Caregivers use the MyChildCMC mobile app to report regular health status information, enabling remote monitoring for early signs of deterioration. The program is offered in English and Spanish and requires access to a smartphone or tablet with internet. Outcomes include healthcare utilization (ED/hospital admissions) and measures of quality of life and care coordination compared between users and usual care.
Who should consider this trial
Good fit: Children aged 1–18 with multisystem chronic conditions (involving three or more organ systems, cared for by three or more providers, with recent frequent or prolonged hospitalizations or medical technology dependence) whose caregivers have a smartphone/tablet and speak English or Spanish are the ideal candidates.
Not a fit: Infants under 1 year, critically ill children, people over 18, and families without reliable internet or a compatible device (or who do not speak English or Spanish) are unlikely to benefit from this app-based intervention.
Why it matters
Potential benefit: If successful, the app could reduce emergency department visits and hospital admissions and improve quality of life by enabling earlier detection and intervention.
How similar studies have performed: Care-coordination programs and remote monitoring for single-condition pediatric illnesses have shown reductions in admissions in observational studies, but no validated remote monitoring app specifically for children with medical complexity has been established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * CMC, ages 1-18 years and their parents (or primary caregivers) * CMC (inpatients or outpatients) who receive care at participating sites (comprehensive care clinics for CMC) * Own (or provided) a smartphone or tablet with internet access * Speak English or Spanish. * CMCs are identified using an operational definition, as having: 1) multisystem chronic diseases involving ≥3 organ systems, 2) ≥3 HCPs involved in their care, 3) high fragility or frequent (≥2) or 1 prolonged (\>10 days) hospitalization in the prior year, and/or 4) medical technology dependence. Exclusion Criteria: * Critically ill CMC and infants. * CMC exhibit similar developmental and functional abilities and typically function below expected for a 7-year-old child, allowing inclusion of a wide age range in studies. * Infants were excluded as many CMC \<1 year have prematurity-related conditions that may resolve by age 2. * CMC \>18 years of age were not included as some may transition to adult health care. * Note: No one will be excluded due to lack of smartphone/internet access. We estimated \<10% of families may not have a smartphone/internet, and will provide them low-cost tablets and cellular internet access.
Where this trial is running
Chicago, Illinois and 1 other locations
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- Primary Children's Hospital — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Flory Nkoy, MD, MS, MPH — University of Utah
- Study coordinator: Flory L Nkoy, MD, MS, MPH
- Email: flory.nkoy@hsc.utah.edu
- Phone: 8012134161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.