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

NCT04470193 | Completed Results

• 1 other identifier: 088596
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Children With Medical Complexity

Keywords

medical complexity; multiple chronic conditions; children

Outcome Measures

Primary Outcomes (1)

• Patient Quality of Life (QOL)

  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.

  Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention

Secondary Outcomes (3)

• Patient Emergency Department (ED)/Hospitalization

  Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention

• Number of Hospital Days

  3-month pre and 3-month post study start

• Parent/Caregiver Satisfaction With Care

  Collected once at study end (3 months)

Study Arms (2)

MyChildCMC Intervention Group

EXPERIMENTAL

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

Standard of Care Group

NO INTERVENTION

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.

Interventions

MyChildCMC app OTHER

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.

MyChildCMC Intervention Group

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Critically ill children in imminent death
• Non-English speakers

Sponsors & Collaborators

• University of Utah: lead
• HRSA/Maternal and Child Health Bureau: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (10)

• 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.

  PMID: 19948596 BACKGROUND

• 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.

  PMID: 9714637 BACKGROUND

• 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.

  PMID: 9651423 BACKGROUND

• 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.

  PMID: 15121916 BACKGROUND

• 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.

  PMID: 23184117 BACKGROUND

• 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.

  PMID: 15882452 BACKGROUND

• 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.

  PMID: 16700928 BACKGROUND

• 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.

  PMID: 17079547 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Baseline hospital days were imbalance, due to small sample size and data skewing. Analysis accounted for skewness and baseline number of ED/hospital admissions were similar, minimizing allocation bias. We had 2 deaths and 1 hospice discharge in MyChildCMC group, suggesting sicker subjects in this group due to our small sample size, or despite sicker children in MyChildCMC group, hospital days dropped but increased in controls, suggesting the effect size may be larger.

Results Point of Contact

• Title: Flory Nkoy, MD, MS, MPH
• Organization: University of Utah

flory.nkoy@hsc.utah.edu

801-662-3660

Study Officials

• Flory Nkoy, MD, MS, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 14, 2020
• Study Start: June 10, 2019
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)