Home-Monitoring Application for Children With Medical Complexity: A Feasibility Trial.
Flory Nkoy, Bryan Stone, Michelle Hofmann...
https://pubmed.ncbi.nlm.nih.gov/33827786Actively Recruiting
Phase Not Applicable
Age: 1Year - 18Years
All Genders
ID06883045
A Novel mHealth Intervention to Improve Outcomes of Children With Medical Complexity
Led by University of Utah · Updated on 2026-01-12
360
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
N
National Institute of Nursing Research (NINR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Children with medical complexity (CMC) have multiple chronic health conditions affecting three or more organ systems, significant functional limitations, and reliance on medical technology. They experience frequent acute health problems leading to repeated emergency department visits and hospital admissions, which impact their quality of life and contribute to high healthcare costs. This research aims to evaluate a new mobile health (mHealth) app, MyChildCMC, designed to monitor early signs of health deterioration in CMC and help reduce hospital visits and admissions over a 12-month period. The study compares two groups of children aged 1 to 18 years and their parents: one group uses the MyChildCMC app daily for six months to track symptoms and vital signs, receiving automated reminders, feedback, alerts, and connection to their healthcare providers; the other group uses usual care with paper diaries to record similar health data. Both groups receive a sensor device to collect oxygen saturation, heart rate, and respiratory rate, along with financial incentives for participation during the first six months. After six months, incentives stop and participants are followed for an additional six months to assess continued app use and effects. Participants will be monitored through regular symptom and vital sign assessments, surveys measuring quality of life, caregiver stress, self-efficacy, and satisfaction, and tracking of emergency department visits and hospital admissions. The study will analyze if using MyChildCMC reduces healthcare use and improves outcomes for CMC and their families, including assessing effects on healthcare disparities among different racial, ethnic, and social groups. The total participation lasts approximately one year, with evaluations at multiple time points.
CONDITIONS
Brief Title
A Novel mHealth Intervention to Improve Outcomes of Children With Medical Complexity
Who Can Participate
Age: 1Year - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children aged 1 to 18 years with medical complexity and their parents or primary caregivers
- Children who receive care at participating comprehensive care clinics for medical complexity
- Ownership or provision of a smartphone or tablet with internet access
- Ability to speak English or Spanish
- Children identified by multisystem chronic diseases affecting three or more organ systems, involvement of three or more healthcare providers, high fragility or frequent/prolonged hospitalizations, and/or medical technology dependence
You will not qualify if you...
- Critically ill children and infants under 1 year old
- Children functioning below expected developmental and functional levels for a 7-year-old child
- Children younger than 1 year due to prematurity-related conditions that may resolve by age 2
- Children older than 18 years who may have transitioned to adult healthcare
- Lack of smartphone or internet access is not an exclusion, as low-cost devices and internet may be provided
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Treatment
Duration - 6 months
Participants use the MyChildCMC app or usual care methods daily to monitor their child's crosscutting symptoms and vital signs, with support through sensors and financial incentives for 6 months.
Daily monitoring with periodic assessments at baseline, 1 month, 3 months, and 6 months post-enrollment
Follow-up
Duration - 6 months
Participants are followed for an additional 6 months after treatment to assess sustainability of outcomes without monitoring incentives.
Periodic assessments up to 12 months post-enrollment
Trial Site Locations
Total: 2 locations
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
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Research Team
F
Flory L Nkoy, MD, MS, MPH
A
Angela Zhu, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Information needs for designing a home monitoring system for children with medical complexity.
Flory L Nkoy, Michelle G Hofmann, Bryan L Stone...
https://pubmed.ncbi.nlm.nih.gov/30623786