N/A
Completed N=50
Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial
Children With Medical Complexity
Source: ClinicalTrials.gov NCT04470193 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Patient Quality of Life (QOL) — 62.7; 54.4; 59.8; 51.9 score on a scale, range from 20 to 100 — p=>0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Quality of Life (QOL) |
62.7; 54.4; 59.8; 51.9; 55.2; 50.8 | >0.05 |
| SECONDARY Patient Emergency Department (ED)/Hospitalization |
1.13; 0.85; 1.08; 0.88 | 0.882 |
| SECONDARY Number of Hospital Days |
9.25; 1.08; 4.54; 2.46 | <0.001 sig |
| SECONDARY Parent/Caregiver Satisfaction With Care |
26.93; 24.14 | 0.035 sig |
Eligibility Criteria
Participant Inclusion Criteria:
Children with complex medical conditions* ages 1 through 20 years with their primary caregiver (primary person caring for the child) who:
- have been seen at Primary Children's Hospital within 365 days,
- own a smartphone or a tablet computer with Internet access, and
- are English speaking *Physician diagnosis was used to determine CMC diagnosis
Exclusion Criteria
- Critically ill children in imminent death
- Non-English speakers
Data sourced from ClinicalTrials.gov (NCT04470193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.