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

Utah System of Higher Education (USHE) logo

Utah System of Higher Education (USHE)

Status

Completed

Conditions

Children With Medical Complexity

Treatments

Other: MyChildCMC app

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

50 patients

Sex

All

Ages

1 to 20 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

MyChildCMC Intervention Group
Experimental group
Description:
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.
Treatment:
Other: MyChildCMC app
Standard of Care Group
No Intervention group
Description:
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.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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