Status:
NOT_YET_RECRUITING
A Novel mHealth Intervention to Improve Outcomes of Children With Medical Complexity
Lead Sponsor:
University of Utah
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Children With Medical Complexity
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief Summary
Children with medical complexity (CMC) are the most vulnerable of children with chronic diseases, who have complex, multisystem chronic diseases affecting ≥3 organ systems, severe functional limitatio...
Detailed Description
Children with medical complexity (CMC) have complex, multisystem chronic diseases, neurological impairments with marked intellectual/physical disabilities, functional limitations, technology dependenc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 12 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06883045
Start Date
January 12 2026
End Date
March 31 2029
Last Update
January 8 2026
Active Locations (2)
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1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113