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

Conditions

• Children With Medical Complexity

Eligibility Criteria

Sex

ALL

Age

1 Year - 18 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Jan 6, 2026

Status verified

Jan 2026

Primary completion

Mar 31, 2029

Completion

Mar 31, 2029

Study Design

Enrollment

360 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: MyChildCMC group
  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.
• Active Comparator: Usual care group
  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.

Primary Outcome Measure

ED/hospital admissions [ Time Frame: 6-month pre and 6-month post enrollment ]

Central Contacts

• Flory L Nkoy, MD, MS, MPH
  8012134161
  [email protected]
• Angela Zhu, BS
  801-662-3675
  [email protected]

Locations (2)

Find similar trials in Chicago, IL

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