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NCT06883045 · ClinicalTrials.gov registry record · NA

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

A NA study of Children With Medical Complexity, sponsored by University of Utah.

Recruiting
Registry status
NA
Development phase
360
Enrollment target
2
Study locations

NCT06883045 is a NA study of Children With Medical Complexity that is actively recruiting participants, run by University of Utah. The registered enrollment target is 360 participants. The trial reports 2 study locations across 2 states.

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The verdict

NCT06883045, a NA study of Children With Medical Complexity, is actively recruiting participants, sponsored by University of Utah.

RECRUITING
Registry status
NA
Development phase
360 participants
Enrollment target
2
Study locations

Study 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

Interventions

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

Study Locations (2)

Illinois

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

Utah

  • Primary Children's Hospital - Salt Lake City

Trial Details

FieldValue
Enrollment Target 360 participants
Start Date 2026-01-06
Est. Completion 2029-03-31
Phase NA

Sponsor

University of Utah

818 total trials

What the Registry Record Tells You About NCT06883045

The ClinicalTrials.gov registry entry for NCT06883045 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Children With Medical Complexity appearing as the primary indexed condition, and to 1 intervention - of which MyChildCMC app (an app designed to facilitate home monitoring of CMC's health status) is the first listed.

NCT06883045 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Illinois, Utah.

Frequently Asked Questions

What is clinical trial NCT06883045 about?

NCT06883045 is a clinical study titled "A Novel mHealth Intervention to Improve Outcomes of Children With Medical Complexity". 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...

What is the current status of trial NCT06883045?

This trial is currently recruiting. It is a NA study. The enrollment target is 360 participants. The study started on 2026-01-06. Estimated completion is 2029-03-31.

What conditions does trial NCT06883045 study?

This clinical trial studies the following conditions: Children With Medical Complexity.

What interventions are being tested in trial NCT06883045?

The interventions under investigation include: MyChildCMC app (an app designed to facilitate home monitoring of CMC's health status) (OTHER).

Who is sponsoring clinical trial NCT06883045?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06883045 being conducted?

This trial has 2 study locations across Illinois, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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