This is a 12-month parallel RCT with 2 arms (MyChildCMC vs control arms) involving CMC (aged 1‐18 years) and their parents (or primary caregivers). Figure 1 presents an overall diagram of the study that complies with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines (Checklist 1) [24].

CMC and primary caregivers are enrolled in Salt Lake City (SLC) and Chicago. The SLC site includes the Pediatric Comprehensive Care Program for CMC [25], at the Primary Children’s Hospital (PCH) outpatient clinic, which cares for more than 1000 unique CMC per year. PCH is an affiliated pediatric hospital of the University of Utah Spencer Fox Eccles School of Medicine owned by Intermountain Health. The Chicago site includes the Lurie Children’s Hospital (LCH) Pediatric Care Coordination and Complex Care Programs, which together care for more than 700 unique CMC per year. LCH is an affiliated pediatric hospital of Northwestern University Feinberg School of Medicine.

Participants are identified electronically by the study teams, assessed for eligibility, and invited to participate remotely (by phone or email), during clinic visits, or during hospital admissions. Eligible participants who agree to participate give informed consent and/or parental permission. CMC aged 7 years or older, if cognitively capable, provide assent. CMC who turn 18 years old during the study provide consent or are consented by a legally authorized representative.

A computer-generated allocation sequence is built into REDCap for randomization. Randomization is stratified by age group (1‐11 vs 12‐18) and child disability severity (6‐15 vs 16‐30) as these factors may affect child outcomes. Child disability severity is measured at enrollment using the Functional Status Scale (FSS), which assesses the child’s functional status across 6 domains with scores ranging from 6 (normal function) to 30 (very severe dysfunction). Participants are allocated into 2 arms in a 1:1 ratio using a block-randomized scheme with random block sizes of either 4 or 6. Once an eligible participant consents and completes baseline surveys, the research team uses REDCap to identify the allocation number (the actual allocation arm is concealed from the study teams) and then discloses it to the participant.

The intervention includes MyChildCMC, an app designed to support remote monitoring to help identify early acute changes in CMC’s health status to promote timely care [26]. The app is available in the Apple App Store and Google Play Store, but access is currently limited to study participants. Parents in the intervention arm receive the app, a sensor, and a thermometer, and training on the study and on measuring and recording vital signs and symptoms in the app. The intervention group also receives help to download the app from the Apple App Store or Google Play Store, an authorization code to access the app, and help in setting up a Bluetooth connection with the sensor to allow the automated transmission of vital signs data. This group uses the sensor/app daily for 12 months postenrollment to monitor their child’s vital signs/symptoms and receive reminders and real-time feedback (summary reports and individual graphs), as well as alerts from the app for abnormal changes in vital signs and symptoms. Alerts indicating early warning signs of deteriorating health in the child with CMC are sent to the parent and care team for follow-up. The care team can view patient data and individual graphs via the dashboard. The app includes the following features [26]:

Participants randomized to the control arm receive a sensor, a thermometer, a logbook (paper diary), and training by the research team on measuring and recording the child’s vital signs/symptoms. Participants in the control arm use the sensor and diary daily for 12 months postenrollment to record and monitor the same vital signs/symptoms as the intervention group, but they do not receive reminders, feedback, or alerts. They are instructed to follow up with the child’s care team on their own as usual if they have any concerns about the child’s health.

Both arms receive their regular clinical care from their care teams, which includes (1) a shared care plan; (2) education about potential interventions to try at home if a child’s parameter is abnormal; (3) a social worker’s consultation and connection to community resources; (4) coordination of medical care, referrals, and appointments, in collaboration with health care providers; and (5) inpatient consultation for hospitalized CMC.

Participants in both arms receive monitoring financial incentives for daily use of the app (intervention arm) or diary (control arm) for the first 6 months of the study, totaling US $120 (~US $10 every 2 weeks for 6 months). App usage (adherence percentage) for every 2 weeks is automatically recorded and made accessible via the dashboard. Diary usage (for every 2 weeks) is monitored through photos of completed logbook pages uploaded by study participants that are accessible through REDCap for research team verification. Participants with greater than 50% adherence to either the app or diary for each 2-week period are sent a US $10 gift card. The efficacy of the MyChildCMC intervention will be assessed at 6 months. We will stop providing monitoring incentives at the end of 6 months and follow participants for 6 more months to assess sustainability at 12 months. All participants also receive US $50 for each survey completed at enrollment and at 3, 6, and 12 months (US $200 total for responding to surveys). Overall, participants receive US $320 total if they complete all study activities.

Efficacy will be assessed at 6 months postenrollment, by comparing multiple outcomes for the child (ED/hospital admissions, number of hospital days, and QOL) and parent (satisfaction, self-efficacy, and stress). The primary outcome measure is the number of ED/hospital admissions (6 months preenrollment and 6 months postenrollment), which is an important public health concern, as CMC have recurrent hospitalizations that account for 40% of all hospital admissions and one-third of health care costs in US children [31]. Secondary outcome measures are total hospital days (6 months preenrollment and 6 months postenrollment), change from baseline in the child’s QOL, parent stress, parent self-efficacy, and parent satisfaction with overall childcare. Sustainability will be assessed at 12 months by comparing adherence and intervention effects between the first and second 6-month periods.

The study was approved by the University of Utah Institutional Review Board (IRB; IRB approval/reference number 00179595) which is also acting as the Single IRB for both the Utah and Chicago sites. Study participants provide consent before completing any study procedures. During the consenting process, participants are informed about the voluntary nature of the study that they can withdraw at any time without consequences and that precautions are in place to ensure the confidentiality of the data and the privacy of study participants. All data and other information collected during the study are stored on a University of Utah HIPAA-compliant secured server, accessible only to the research team. As this is an RCT, the study was registered on ClinicalTrials.gov (ID: NCT06883045).

Compared to the control arm, we expect the current study to show that MyChildCMC users have fewer hospital admissions, fewer hospital days, lower parental stress, and higher child’s QOL scores, parent satisfaction, and parent self-efficacy in managing their child’s health. The expectation of positive results is based on MyChildCMC's ability to MyChildCMC to help detect signs of health deterioration in CMC early (up to 14 days in advance) and to support timely care, which can help reduce hospital admissions. Frequent hospital admissions among CMC can lead to poorer QOL. Also, long-term caregiving can be stressful and lead to poor caregiver’s health [24,43-46]. Thus, a reduction in hospital admissions may lead to improved child QOL, reduced caregiver stress, and improved caregiver satisfaction. We also expect that adherence to MyChildCMC and intervention effects achieved at 6 months will be sustained at 12 months as the app may offer tangible benefits and value to parents of CMC (eg, reduction in hospital visits).

Improved survival of children with conditions previously incompatible with life have led to growing CMC populations [47-51]. Also, a recent paper has shown that CMC hospitalizations have increased over the past decade [8]. Due to high medical fragility, CMC experience frequent acute health deteriorations, leading to recurrent hospitalizations and high health care costs [11,52-58]. Despite high costs, CMC are often excluded from clinical studies including RCTs, and evidence-based interventions are rare [11,59]. To reduce ED/hospital admissions for CMC, remote monitoring has been suggested [60-62]. For children, this enables parents, in collaboration with a care team, to better manage their child’s condition at home by monitoring symptoms and/or behaviors, identifying/responding to early signs of deterioration, and seeking/providing timely care when needed.

There is traction for using apps to support remote monitoring, improve care, and reduce CMC hospitalizations [7,20,60-62]. Effective remote monitoring of chronic diseases can enhance care coordination, improve outcomes, and reduce admissions [7,20,63-72], mainly due to early recognition and timely management of acute changes in a patient’s health status [7,20,31,50,73-78]. mHealth apps are generally used to support remote monitoring [61,62] of single chronic diseases (eg, asthma, diabetes, etc) [79-84] and empower families and care teams to recognize and act on early changes in a patient’s health status [7,20,60,85]. However, no such apps have been implemented for CMC. To date, few authors have reported on the usability of a remote monitoring app, but these apps target only a subset of CMC (eg, those with enteral feeding tubes), with no evaluation of impact [7,20,22,86]. Also, Werner et al [87] conducted an RCT to assess the impact of an app designed to improve medication administration accuracy but not the health status of CMC. Variable, multisystem conditions make it difficult to develop remote monitoring apps for CMC. Despite multiple and variable underlying conditions, hospital admissions for CMC are often preceded by a limited set of shared or common (crosscutting) acute symptoms, including fever, respiratory distress with decreased oxygenation, feeding/fluid intolerance, altered mental status (sometimes seizures), and pain [62,88,89]. MyChildCMC was developed to monitor and identify early changes in cross-cutting symptoms among CMC.

Our study is unique as it introduces a novel and practical approach to monitoring all CMC by targeting crosscutting symptoms, rather than individual conditions or isolated symptomatic complaints (ie, respiratory vs neurologic), making remote monitoring for CMC possible despite multiple and variable conditions. The MyChildCMC intervention is also aligned with the Institute of Medicine, which warned against designing care for patients with multiple chronic diseases around single-disease interventions rather than around common features [90,91]. Also, the use of an FDA-approved sensor, integrated with the MyChildCMC app (via Bluetooth), allows automated and accurate recording of vital signs data in the app, minimizing the data-collection burden on families. Long-term caregiving can negatively impact the health of parents of CMC. Our study will be the first to explore if remote monitoring not only improves CMC outcomes but also improves parents’ caregiving self-efficacy in managing child’s conditions and reduces parental stress. Finally, CMC are often excluded from clinical studies, and RCTs involving CMC are rare [11,59]. Our study is unique in that it is an RCT involving CMC.

Our study protocol has a few potential limitations that may affect the interpretation of the results. First, one may think that our study population’s age range (1‐18 y) is too wide. This age range was included because CMC exhibit similar developmental and functional abilities and typically function below what is expected for a typical 7-year-old child, allowing the inclusion of a wide age range in research studies. Second, one may think that future dissemination of MyChildCMC intervention will be challenging in terms of sensor costs, manpower, and time for training. Further, the time for care coordinator and clinician review is variably reimbursed across Medicaid programs and private pay plans, which may limit sustainability. However, if MyChildCMC is found to be associated with a significant reduction in hospital admissions, the results could be used as an important evidence base to justify its medical necessity and potential cost savings to the health system, as well as an incentive for health care insurances to support sensor-related costs. Also, after initial and one-time training (that can be provided by care coordinators), use of sensor/app is straightforward, involving only parents/caregivers. Follow-up care triggered by MyChildCMC use is standard of care for CMC. We are anticipating our future cost-effectiveness study to demonstrate significant cost savings as hospital admissions account for most CMC-related health care costs. Third, because of the type of our intervention, it was not possible to blind study participants to the intervention (MyChildCMC) or control (diary). Therefore, the intervention group may report better outcomes as they may be more motivated to participate than the control group, leading to potential bias. However, the primary outcome (hospital admissions) will be collected electronically. This will minimize the risk bias in the reporting of the intervention effect. Finally, we are providing similar study materials (sensor and digital thermometer) and incentives (for daily monitoring and responding to surveys) to both study arms. The difference is that the intervention group monitors their child’s vital signs/symptoms using the app, while the control group monitors the same parameters using a diary. Therefore, the results obtained from the study will reflect the true impact of MyChildCMC app.

MyChildCMC is a promising app that has been shown in a pilot trial to improve CMC and parent outcomes. If efficacious, MyChildCMC will serve as a new model for improving care and reducing hospital admissions in CMC, which can be generalized to all children with multiple chronic conditions, with potential for national dissemination to reduce CMC-related care burden in the United States.