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

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.

Study Overview

• Status: Completed
• Conditions: Children With Medical Complexity
• Intervention / Treatment: Other: MyChildCMC app

Detailed Description

Aim: Investigators will assess the impact of the MyChildCMC app by comparing outcomes for the child and caregiver with the following outcomes:

1. Child Quality of Life (QOL)
2. Child Hospital and Emergency Department (ED) admissions
3. Parent/Caregiver satisfaction with care
4. Study participation rate
5. Retention of intervention (intervention arm only)
6. Adherence of intervention (intervention arm only)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MyChildCMC Intervention Group; 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; 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.
No Intervention: Standard of Care Group; 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?

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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: HRSA/Maternal and Child Health Bureau
• Investigators: Principal Investigator: Flory Nkoy, MD, MS, MPH, University of Utah

Publications and helpful links

General Publications

• Cohen E, Berry JG, Camacho X, Anderson G, Wodchis W, Guttmann A. Patterns and costs of health care use of children with medical complexity. Pediatrics. 2012 Dec;130(6):e1463-70. doi: 10.1542/peds.2012-0175. Epub 2012 Nov 26.
• Kogan MD, Strickland BB, Newacheck PW. Building systems of care: findings from the National Survey of Children With Special Health Care Needs. Pediatrics. 2009 Dec;124 Suppl 4:S333-6. doi: 10.1542/peds.2009-1255B. No abstract available.
• McPherson M, Arango P, Fox H, Lauver C, McManus M, Newacheck PW, Perrin JM, Shonkoff JP, Strickland B. A new definition of children with special health care needs. Pediatrics. 1998 Jul;102(1 Pt 1):137-40. doi: 10.1542/peds.102.1.137. No abstract available.
• Newacheck PW, Strickland B, Shonkoff JP, Perrin JM, McPherson M, McManus M, Lauver C, Fox H, Arango P. An epidemiologic profile of children with special health care needs. Pediatrics. 1998 Jul;102(1 Pt 1):117-23. doi: 10.1542/peds.102.1.117.
• Strickland B, McPherson M, Weissman G, van Dyck P, Huang ZJ, Newacheck P. Access to the medical home: results of the National Survey of Children with Special Health Care Needs. Pediatrics. 2004 May;113(5 Suppl):1485-92.
• Feudtner C, Villareale NL, Morray B, Sharp V, Hays RM, Neff JM. Technology-dependency among patients discharged from a children's hospital: a retrospective cohort study. BMC Pediatr. 2005 May 9;5(1):8. doi: 10.1186/1471-2431-5-8.
• Dolk H, Parkes J, Hill N. Trends in the prevalence of cerebral palsy in Northern Ireland, 1981-1997. Dev Med Child Neurol. 2006 Jun;48(6):406-12; discussion 405. doi: 10.1017/S0012162206000909.
• Farooqi A, Hagglof B, Sedin G, Gothefors L, Serenius F. Chronic conditions, functional limitations, and special health care needs in 10- to 12-year-old children born at 23 to 25 weeks' gestation in the 1990s: a Swedish national prospective follow-up study. Pediatrics. 2006 Nov;118(5):e1466-77. doi: 10.1542/peds.2006-1070.
• Association CsH. Optimizing Health Care for Children with Medical Complexity Annual Report 2013:2.
• Vestal C. Improving Medicaid for 'Medically Complex' Kids. The Pew Charitable Trusts 2015;January 08.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): March 19, 2020
• Study Completion (Actual): March 19, 2020

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: children; multiple chronic conditions; medical complexity
• Other Study ID Numbers: 088596

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No