Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial

Not Applicable

Completed

Conditions: Children With Medical Complexity

Interventions: Other: MyChildCMC app

Registration Number: NCT04470193

Lead Sponsor: University of Utah

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MyChildCMC Intervention Group	MyChildCMC app	Parents/patients randomized into the MyChildCMC Intervention Group will use the MyChildCMC app to monitor their child's daily symptoms for the duration of the study period (3 months). The MyChildCMC app includes a daily form consisting of 12 questions assessing child's vitals, pain, seizures, mood, and feeding as well as caregiver worry for the day. Daily reminders are sent to the parent to fill out the vitals form in the app. Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.

Primary Outcome Measures

Name	Time	Method
Patient Quality of Life (QOL)	Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention	Compared Mean QOL Change from Baseline to Each Follow-up Assessment Between the Two study Groups, using the Ellzey et. al.'s QOL survey questionnaire for children with complex medical conditions, which assesses multiple domains including physical health, mental health, sleep, pain, activities and general QOL. The total QOL score was reported and standardized to 100 points, with scores ranging from 20 (the lowest QOL) to 100 (the highest QOL). Higher QOL scores represent a better outcome.

Secondary Outcome Measures

Name	Time	Method
Patient Emergency Department (ED)/Hospitalization	Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention	Compare NUMBER of ED and hospital admissions 3-month pre, and 3-month post study initiation between the intervention and Usual care groups.
Number of Hospital Days	3-month pre and 3-month post study start	Number of days (duration) participants were hospitalized
Parent/Caregiver Satisfaction With Care	Collected once at study end (3 months)	Caregiver satisfaction with overall care of their children, using an adapted version (by Ellzey et. al) of Client Satisfaction Questionnaire for children with complex medical conditions, which has 6 questions measuring caregiver's confidence with ability to take care of child's health, consistency in doing things needed to take care of the child, availability of medical professional support, availability of social support, availability of a monitory system to help with child's home care and stress about child's health. We reported the total caregiver satisfaction scores, which range from 5 (the lowest satisfaction) to 30 (the highest satisfaction). Higher caregiver satisfaction scores represent a better outcome.