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

Study Overview
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Brief Summary
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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 feasibility trial for the MyChildCMC app will determine app feasibility and 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
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Aim: Investigators will assess the impact of the MyChildCMC app by comparing outcomes for the child and caregiver with the following outcomes: Child Quality of Life (QOL) Child Hospital and Emergency Department (ED) admissions Parent/Caregiver satisfaction with care Study participation rate Retention of intervention (intervention arm only) Adherence of intervention (intervention arm only)

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

Conditions
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Children With Medical Complexity

Intervention / Treatment
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* Other: MyChildCMC app


Participation Criteria
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Eligibility Criteria
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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 wa used to determine CMC diagnosis Exclusion Criteria: Critically ill children in imminent death Non-English speakers

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MyChildCMC Intervention Group<br>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. | Other: MyChildCMC app<br>* Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time.<br>|
| No Intervention: Standard of Care Group<br>Parents/patients randomized into the Standard of Care Group do not use the MyChildCMC app to monitor their child's daily symptoms and are instructed to continue with regular care for their child and to continue monitoring their child's symptoms on their own without the use of the app for the duration of the study period (3 months). 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Quality of Life (QOL) | Compared Mean QOL Change from Baseline to Each Follow-up Assessment Between the Two Intervention Groups, using the QOL survey questionnaire for children with complex medical conditions (adapted from Ellzey et. al), which assesses multiple domains including physical health, mental health, sleep, pain, activities and general QOL. | QUality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Emergency Department (ED)/Hospitalization | Compare NUMBER of ED and hospital admissions, 3-month prior the study intervention and 3-month post start of the study intervention. | Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention | 
| Parent/Caregiver Satisfaction with Care | Caregiver Satisfaction with overall care of their children, using satisfaction survey questionnaire for children with complex medical conditions (published by Ellzey et. al), which measure, 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. | Collected once at study end (3 months) | 
| Study Participation Rate | Percentage of eligible subjects who agreed to participate out of those who were approached | Collected once at study end (3 months) | 
| Patient retention to intervention (intervention arm only) | Percentage of patient/parents in the intervention arm who completed the final QOL or vitals assessment during the study period | Collected at 1 month and 3 months | 
| Patient adherence to intervention (intervention arm only) | Percentage of daily vital signs/symptoms recorded over the 3 month period out of all opportunities | Collected at 1 month and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical complexity, multiple chronic conditions, children