MyChildCMC App for Complex Medical Needs

Not yet recruiting at 1 trial location

Overseen By Flory L Nkoy, MD, MS, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Critically ill, Infants, Over 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called MyChildCMC, designed to help parents monitor children with complex medical needs. The app aims to catch early warning signs of health issues to prevent emergency room visits and hospital stays. The trial compares the app to usual care methods, such as keeping a paper diary. It seeks children aged 1-18 with conditions affecting multiple organ systems who often require hospital care. Parents will use the app daily for six months to determine if it reduces hospital visits and improves quality of life. As an unphased trial, this study offers parents a unique opportunity to contribute to innovative solutions that could significantly enhance their child's healthcare experience.

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 prior data suggests that the MyChildCMC app is safe for children with medical complexity?

Research has shown that the MyChildCMC app helps parents track the health of children with complex medical needs. In a small study with 50 participants, the app detected early signs of health issues 2-14 days before a hospital visit. Families using the app spent fewer days in the hospital compared to those who didn't use it.

Although the app is still new, the study found that families find it easy to use. No major problems were reported, indicating that parents and children didn't experience significant issues while using the app. Users found it helpful for managing their child's health, suggesting it can be a safe and effective tool for home monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MyChildCMC app because it offers a fresh approach to managing complex medical conditions, focusing on proactive care. Unlike traditional methods that rely on paper diaries for tracking symptoms, the app provides automated reminders and a real-time feedback system. This innovation allows for early detection of health deterioration, potentially preventing emergency room visits and hospital admissions. Additionally, the app seamlessly connects patients with clinics through a dashboard, enhancing care coordination and ensuring timely interventions.

What evidence suggests that the MyChildCMC app is effective for reducing ED/hospital admissions in children with medical complexity?

Research has shown that the MyChildCMC app, available to participants in this trial, may benefit children with complex medical needs. An initial study identified early signs of health issues 2-14 days before hospital visits, resulting in fewer hospital days. This suggests the app helps parents detect problems early and avoid emergency visits. Features such as reminders and real-time feedback assist parents in monitoring their children's health at home. Overall, early results suggest the app is practical and effective in improving care for these children. ^{1 2 5 6 7}

Who Is on the Research Team?

Flory Nkoy, MD, MS, MPH

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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

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

I have a chronic condition affecting 3 or more organ systems, see multiple doctors, and have been frequently hospitalized or depend on medical technology.

Exclusion Criteria

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.

My child is critically ill.

My child is older than 1 year and does not have conditions related to being born early.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the MyChildCMC app daily for 6 months to monitor crosscutting symptoms and receive feedback

6 months

Daily app usage

Follow-up

Participants are monitored for sustainability of app usage and outcomes without financial incentives

6 months

What Are the Treatments Tested in This Trial?

Interventions

• MyChildCMC app

Trial Overview The MyChildCMC app is being tested in a study where one group uses the app daily for remote monitoring of their child's health, while another receives usual care. The goal is to see if the app can reduce emergency/hospital visits and improve quality of life.

How Is the Trial Designed?

Group I: MyChildCMC group Experimental Treatment 1 Intervention

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.

Group II: Usual care group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

In a 1-year study involving 310 parents of children with chronic diseases, the incidence of medication errors (MEs) was found to be 0.46 errors per child, with the highest risk observed in children under 1 year old (1.69 errors per child).

Children discharged from the cardiology unit had a significantly higher risk of medication errors (IRR of 3.66), highlighting the need for targeted monitoring and support for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cell-Phone Medication Error eHealth App for Managing Safety in Chronically Ill Young Patients at Home: A Prospective Study. Tiozzo, E., Rosati, P., Brancaccio, M., et al.[2023]

A point-of-care screening algorithm was successfully implemented to identify children with medical complexity (CMC) among hospitalized patients, categorizing 2187 inpatients into three groups based on their health care needs.

Children identified as CMC had significantly more complex chronic conditions and higher hospital resource use compared to those with special health care needs or previously healthy children, indicating they are a key group that could benefit from enhanced care coordination services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-Care Complexity Screening Algorithm to Identify Children With Medical Complexity. Parente, V., Parnell, L., Childers, J., et al.[2022]

The study involved 16 participants, including family caregivers and clinicians, who identified 11 medication safety challenges faced by caregivers of children with medical complexity, highlighting the need for better support in medication management.

Design requirements for a mobile health application were developed to enhance medication safety by improving communication and ensuring timely administration, with plans for future testing to evaluate its effectiveness in reducing medication errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An mHealth design to promote medication safety in children with medical complexity. Jolliff, A., Coller, RJ., Kearney, H., et al.[2023]

Citations

1. publications.aap.org publications.aap.org/hospitalpediatrics/article/11/5/492/180755/Home-Monitoring-Application-for-Children-With

Home-Monitoring Application for Children With Medical ... MyChildCMC was feasible and appears effective, with the potential to detect early deteriorations in health for timely interventions that might avoid ED and ...

2. reporter.nih.gov reporter.nih.gov/project-details/11113951

RePORT RePORTER - National Institutes of Health (NIH) | : Findings from this project will provide an effective, practical, and generalizable approach to supporting home monitoring of children with medical complexity ...

3. withpower.com withpower.com/trial/phase-children-with-medical-complexity-2-2025-c42b9

MyChildCMC App for 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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33827786/

Home-Monitoring Application for Children With Medical ... Conclusions: MyChildCMC was feasible and appears effective, with the potential to detect early deteriorations in health for timely interventions that might ...

5. researchgate.net researchgate.net/publication/350768305_Home-Monitoring_Application_for_Children_With_Medical_Complexity_A_Feasibility_Trial

Home-Monitoring Application for Children With Medical ... Conclusions: MyChildCMC was feasible and appears effective, with the potential to detect early deteriorations in health for timely interventions that might ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39250787/

Effectiveness of a Mobile App (Meds@HOME) to Improve ... The Meds@HOME mobile app provides a promising strategy for improving PCG medication safety for CMC who take high-risk medications.

7. researchprotocols.org researchprotocols.org/2024/1/e60621

Effectiveness of a Mobile App (Meds@HOME) to Improve ... This study will pilot-test the mobile app, Medication Safety @HOME—Meds@HOME intervention to improve medication administration accuracy ...