MyChildCMC App for Complex Medical Needs
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It seems likely that you can continue your current medications, but please confirm with the trial coordinators.
What data supports the effectiveness of the MyChildCMC app treatment for children with complex medical needs?
Research suggests that mobile health tools like the MyChildCMC app can help monitor symptoms at home, potentially reducing emergency visits and hospitalizations for children with complex medical needs. Caregivers believe such tools are beneficial for tracking early signs of health changes, which can lead to timely interventions.12345
Is the MyChildCMC app safe for use in children with complex medical needs?
The MyChildCMC app has been designed to help monitor children with complex medical needs at home, aiming to reduce emergency visits and hospitalizations. While specific safety data for the app itself isn't detailed, similar apps have been used to improve medication safety and have been found easy to use by parents, suggesting a focus on safety in its design.12367
How is the MyChildCMC app treatment different from other treatments for children with medical complexity?
The MyChildCMC app is unique because it focuses on home monitoring to detect early health deteriorations and reduce emergency visits and hospitalizations for children with complex medical needs. Unlike traditional treatments, it uses mobile technology to support caregivers in managing the child's health at home, potentially improving medication safety and care coordination.138910
Research Team
Flory Nkoy, MD, MS, MPH
Principal Investigator
University of Utah
Eligibility Criteria
This trial is for children aged 1-18 with complex medical needs affecting multiple organ systems, severe functional limitations, and technology dependencies. It aims to help those who have frequent hospital visits and are at risk of health care inequities.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the MyChildCMC app daily for 6 months to monitor crosscutting symptoms and receive feedback
Follow-up
Participants are monitored for sustainability of app usage and outcomes without financial incentives
Treatment Details
Interventions
- MyChildCMC app
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
National Institute of Nursing Research (NINR)
Collaborator