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

Children With Medical Complexity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04470193
• Other study ID #: 088596
• Status: Completed
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: March 19, 2020

Study information

• Verified date: July 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Children With Medical Complexity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

United States, 

References & Publications (10)

Association CsH. Optimizing Health Care for Children with Medical Complexity Annual Report 2013:2.

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. — View Citation

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. — View Citation

Farooqi A, Hägglöf 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Vestal C. Improving Medicaid for 'Medically Complex' Kids. The Pew Charitable Trusts 2015;January 08.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	Study Participation Rate	Percentage of eligible subjects who agreed to participate out of those who were approached	Collected once at study end (3 months)
Secondary	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
Secondary	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