Clinical trial NCT04470193: Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial
Official title: Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children With Medical Complexity
Keywords: medical complexity
multiple chronic conditions
children
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2020-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

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

Primary outcomes:
measure: Patient Quality of Life (QOL)
timeFrame: Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention
Secondary outcomes:
measure: Patient Emergency Department (ED)/Hospitalization
timeFrame: Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention
measure: Number of Hospital Days
timeFrame: 3-month pre and 3-month post study start
measure: Parent/Caregiver Satisfaction With Care
timeFrame: Collected once at study end (3 months)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Flory Nkoy, MD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
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