A Novel mHealth Intervention to Improve Outcomes of Children With Medical Complexity

NCT06883045 | Recruiting

• 2 other identifiers: 001795951R01NR020784-01A1
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief Summary

Children with medical complexity (CMC) are the most vulnerable of children with chronic diseases, who have complex, multisystem chronic diseases affecting ≥3 organ systems, severe functional limitations and technology dependencies. CMC have high health care needs, and account for 40% of hospitalized children and 35% of all pediatric health care costs. Due to high medical fragility, CMC have frequent acute deteriorations superimposed on their chronic conditions, leading to recurrent emergency department (ED)/hospital admissions and affecting quality of life (QOL). To reduce ED/hospital admissions for CMC, remote monitoring is suggested, with use of mHealth apps to regularly assess their health status remotely and identify early signs of acute deterioration, allowing for early interventions to prevent ED/hospital admissions. Yet no app to support remote monitoring of CMC exists. Variable, multisystem conditions among CMC make it difficult to develop an app. Also, many CMC are at high-risk for health care inequities, with minorities having higher unmet needs, but the impacts of health care inequities and social determinants of health (SDOH) on ED/hospital admissions in CMC are rarely studied. Fortunately, ED/hospital admissions for CMC are often preceded by a limited set of shared (crosscutting) acute symptoms. These crosscutting symptoms rarely occur suddenly. Studies suggest that they usually start as subtle signs, often unnoticed by parents until they escalate to prompt an ED/hospital visit. Thus, crosscutting symptoms offer an opportunity for a novel and practical approach for developing a remote monitoring app for CMC, despite their multiple, variable underlying conditions. In a focus group, parents identified the crosscutting symptoms that most often preceded their children's hospital admissions, and conveyed their needs, preferences and key functionalities that led to MyChildCMC, the first app designed to monitor and identify early signs of crosscutting symptoms in CMC. In a pilot trial of 50 subjects, we confirmed feasibility of MyChildCMC use by parents, ability to detect early signs 2-14 days prior to ED/hospital admissions, and use leading significantly to fewer hospital days than controls. The current study will assess the efficacy and sustainability of MyChildCMC in a fully-powered 6-month, 2-arm (MyChildCMC vs usual care) trial of CMC (age 1-18 years) and their parents. Parents assigned to MyChildCMC will use the app daily for 6 months, both arms will receive financial incentive for participation, then we will stop the incentive and follow subjects for 6 more months to assess sustainability at 12 months. We will also assess if MyChildCMC use will help reduce or eliminate inequities in ED/hospital admissions. Specific Aims are: 1) Determine MyChildCMC's efficacy on 1.a. Child (ED/hospital use, hospital days and QOL) and 1.b. Parent (satisfaction, self-efficacy and stress) outcomes; 2) Compare ED/hospital use among racial/ethnic and SDOH subgroups to assess potential effect of MyChildCMC on inequities.

Conditions

Children With Medical Complexity

Outcome Measures

Primary Outcomes (1)

• ED/hospital admissions

  Numbers of ED and hospital admissions will be assessed pre-post enrollment.

  6-month pre and 6-month post enrollment

Secondary Outcomes (4)

• Child's quality of life (QOL)

  Baseline, 1 month, 3 months and 6 months post-enrollment

• Self-efficacy scale

  Baseline, 1 month, 3 months and 6 months post-enrollment

• Caregiver stress

  Baseline, 1 month, 3 months and 6 months post-enrollment

• Parent satisfaction

  Baseline and 6 months post-enrollment

Study Arms (2)

MyChildCMC group

EXPERIMENTAL

MyChildCMC is an app designed to support remote monitoring of CMC crosscutting symptoms to identify signs of CMC's health deterioration early to change their care early to avoid progression and prevent ED/hospital admissions. The app includes the following features: 1) automated reminders, 2) vital sign/symptom monitoring, 3) real-time feedback system, 4) automated and real-time summary reports with longitudinal graphs, 5) automated alerts to a care coordinator, and 6) clinic dashboard connecting patients to clinics and allowing access to patient data to support care coordination. Those randomized to MyChildCMC will use the app daily for 6 months to monitor vital signs/symptoms. They will also receive a sensor (Masimo Mighty Sat) to facilitate collection of Oxygen saturation, heart rate and respiratory rate, as well as financial incentive for daily monitoring (monitoring incentive) for 6-months and for responding to surveys.

Other: MyChildCMC app (an app designed to facilitate home monitoring of CMC's health status)

Usual care group

ACTIVE COMPARATOR

Those assigned to usual care will use a paper diary to monitor their vital signs and symptoms daily for 6 months. They will also receive a sensor (Masimo Mighty Sat) to facilitate collection of Oxygen saturation, heart rate and respiratory rate, as well as financial incentive for daily monitoring (monitoring incentive) for 6-months and for responding to surveys.

Other: MyChildCMC app (an app designed to facilitate home monitoring of CMC's health status)

Interventions

MyChildCMC app (an app designed to facilitate home monitoring of CMC's health status) OTHER

MyChildCMC is an app designed to support remote monitoring of CMC crosscutting symptoms to identify signs of CMC's health deterioration early to change their care early to avoid progression and prevent ED/hospital admissions. The app includes the following features: 1) automated reminders, 2) vital sign/symptom monitoring, 3) real-time feedback system, 4) automated and real-time summary reports with longitudinal graphs, 5) automated alerts to a care coordinator, and 6) clinic dashboard connecting patients to clinics and allowing access to patient data to support care coordination.

MyChildCMC group; Usual care group

Eligibility Criteria

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

You may qualify if:

• CMC, ages 1-18 years and their parents (or primary caregivers)
• CMC (inpatients or outpatients) who receive care at participating sites (comprehensive care clinics for CMC)
• Own (or provided) a smartphone or tablet with internet access
• Speak English or Spanish.
• CMCs are identified using an operational definition, as having: 1) multisystem chronic diseases involving ≥3 organ systems, 2) ≥3 HCPs involved in their care, 3) high fragility or frequent (≥2) or 1 prolonged (\>10 days) hospitalization in the prior year, and/or 4) medical technology dependence.

You may not qualify if:

• Critically ill CMC and infants.
• Infants were excluded as many CMC \<1 year have prematurity-related conditions that may resolve by age 2.
• CMC \>18 years of age were not included as some may transition to adult health care.
• Note: No one will be excluded due to lack of smartphone/internet access. We estimated \<10% of families may not have a smartphone/internet, and will provide them low-cost tablets and cellular internet access.

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

RECRUITING

Related Publications (2)

• Nkoy F, Stone B, Hofmann M, Fassl B, Zhu A, Mahtta N, Murphy N. Home-Monitoring Application for Children With Medical Complexity: A Feasibility Trial. Hosp Pediatr. 2021 May;11(5):492-502. doi: 10.1542/hpeds.2020-002097. Epub 2021 Apr 7.

  PMID: 33827786 BACKGROUND

• Nkoy FL, Hofmann MG, Stone BL, Poll J, Clark L, Fassl BA, Murphy NA. Information needs for designing a home monitoring system for children with medical complexity. Int J Med Inform. 2019 Feb;122:7-12. doi: 10.1016/j.ijmedinf.2018.11.011. Epub 2018 Nov 26.

  PMID: 30623786 BACKGROUND

Study Officials

• Flory Nkoy, MD, MS, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flory L Nkoy, MD, MS, MPH

CONTACT

8012134161; flory.nkoy@hsc.utah.edu

Angela Zhu, BS

CONTACT

801-662-3675; angela.zhu@hsc.utah.edu

Study Design

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

Model Details: We will assess the efficacy MyChildCMC app in a 6-month, 2-arm (MyChildCMC vs usual care) trial of Children with Medical Complexity (CMC) of ages between 1-18 years and their parents. Parents assigned to MyChildCMC will use the app daily for 6 months to monitor their vital signs/symptoms. Those assigned to usual care will use a paper diary for 6 months to monitor their vital signs/symptoms. Both arms will receive financial incentive for daily monitoring (monitoring incentive) and for responding to surveys.

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 19, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)