Parental Adherence of a Mobile Application

NCT06672042 | Withdrawn FDA Device

• 1 other identifier: STUDY00003221
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-site, stratified grouping parallel- randomized control trial design comparing 30-day all-cause readmission rates and parent experience with two groups of pediatric participants.

Conditions

Pediatrics; Medically Complex; Children With Medical Complexity (CMC); Nursing

Keywords

mHealth; Software Platform; remote patient monitoring

Outcome Measures

Primary Outcomes (1)

• All Cause Readmission

  During the time period- 30 days after nearest discharge from study enrollment- Any Inpatient or observation encounters to a hospital setting

  30 days

Secondary Outcomes (5)

• Home Monitoring Data Adherence

  30 days

• Length of Readmission

  30 days

• Parental Experience

  30 days

• Initiation Adherence

  30 days

• Discontinuation Adherence

  30 days

Other Outcomes (1)

• Healthcare Team Engagement

  30 days

Study Arms (2)

Proactive Nursing Care model using a mobile application and software platform

EXPERIMENTAL

* Includes weekly data monitoring by the study team clinical nurse coordinators with communication through phone, email, or patient portal with documentation in the EMR * Email delivery of data summary reports on each child's data to their outpatient providers, Unrestricted research team approved healthcare team provider access to this data through the CHAMP App PARAMETER web portal, * Follow-up communications from providers to parents at provider discretion, and initiation of Health interventions by providers as deemed clinically appropriate from their review of the data collected and their knowledge of the participant. * Parents will enter home monitoring data daily into the CHAMP App as fitting with their discharge regimen: This may include Feeding, oxygen saturation, heart rate, videos, weight (home scale), or a combination of these.

Device: CHAMP App

Standard of care control arm

NO INTERVENTION

* No proactive monitoring or communication from the research coordinators * Follow-up communications from providers to parents at their general healthcare providers discretion, and Initiation of health interventions by providers as deemed clinically appropriate from their review of the data collected and reported by parents via patient portal, phone, and in-person communications and their knowledge of the participant. * Parents will be provided a paper log that they will utilize for recording their child's home monitoring data and turn in at the end of the month * Parents will write down the home monitoring data fitting with their child's discharge regimen: This may include Feeding, oxygen saturation, heart rate, videos, weight (home scale), or a combination of these. * Optional: Parents can utilize the App if they allocate to Arm 2 (Paper) at first, with a combined weekly check-in with the research coordinators. The parents will get a chance to fill out SUS after month of use

Interventions

CHAMP App DEVICE

CHAMP® App is a proprietary, downloadable, mobile Software Application and software platform designed and developed by the Children's Mercy Hospital of Kansas City (CMH), that permits parents and caregivers to transmit to the care team data to permit remote monitoring of the patient's condition. The parent or caregiver enters into the CHAMP App data including vital signs, intake and output, video, and images of patients (collectively, "CHAMP® Data"), which operates on computers, mobile devices, and handheld computers. The CHAMP® App is intended to be used in the clinical care of pediatric patients in the home setting that are followed by specialty health care teams to improve patient self-management through the use of asynchronous data. Videos and data related to the patient are entered by the parent and sent electronically to the Clinical Care Team as recommended by the clinical team.

Proactive Nursing Care model using a mobile application and software platform

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 0-3 years 11 months with a parent/Legally authorized representative
• Children with complex medical conditions with medical technologies (feeding, oxygen saturation monitor, and/or oxygen equipment) prescribed by the inpatient care team,
• Discharging to a home setting with parents/legally authorized representatives (LAR's) who can read primarily English, Spanish, Somali, Burmese, Korean, Chinese-Simplified, German, French, Filipino, Arabic, and Vietnamese.
• Availability to download a mobile application onto a parent/LAR-owned device
• Additionally, adult participants will also be included and grouped as follows:
• Adult Group 1: Parents/Legally authorized representatives of pediatric subject as part of a dyad.
• Adult Group 2: Healthcare team users at Children's Mercy Kansas City.

You may not qualify if:

• Inability to be discharged to care in the home setting.
• We will exclude a child who is followed solely by the Cardiac High Acuity Monitoring Program Heart Center outpatient team as randomization for this patient population would impact the study design (NCT0603439)
• Those children with PICC lines as their only medical technology.
• Equitable Selection: Parent/LAR that do not speak or read one of the 11 languages available in the CHAMP application will be excluded due to potential translation limits of the app.
• Healthcare team users: Non-Employees of Children's Mercy.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Related Publications (3)

• Hall M, Berry JG, Hall M, Goodwin EJ, Margaret Wright S, Bettenhausen J, Colvin JD. Changes in hospitalization populations by level of complexity at children's hospitals. J Hosp Med. 2024 May;19(5):399-402. doi: 10.1002/jhm.13292. Epub 2024 Feb 10.

  PMID: 38340352 BACKGROUND

• Shirali G, Erickson L, Apperson J, Goggin K, Williams D, Reid K, Bradley-Ewing A, Tucker D, Bingler M, Spertus J, Rabbitt L, Stroup R. Harnessing Teams and Technology to Improve Outcomes in Infants With Single Ventricle. Circ Cardiovasc Qual Outcomes. 2016 May;9(3):303-11. doi: 10.1161/CIRCOUTCOMES.115.002452. Epub 2016 May 10.

  PMID: 27166202 BACKGROUND

• Elliott M, Erickson L, Russell CL, Chrisman M, Gross Toalson J, Emerson A. Defining a new normal: A qualitative exploration of the parent experience during the single ventricle congenital heart disease interstage period. J Adv Nurs. 2021 May;77(5):2437-2446. doi: 10.1111/jan.14785. Epub 2021 Feb 16.

  PMID: 33591609 BACKGROUND

Study Officials

• Lori Erickson, PhD

  Children's Mercy Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Remote Health Solutions

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)