AzTrials
AzTrials

PediatricsPARAMETERNCT06672042

Parental Adherence of a Mobile Application

A study testing CHAMP App in people with Pediatrics and Medically Complex, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 0 years and older
What is being tested?
CHAMP App
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Aug 2025to Aug 2028
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Inability to be discharged to care in the home setting.
  • Those not meeting the above inclusion criteria.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Mercy Kansas City

    Kansas City, Missouri, 64108

Other trials in United States

About this study

Official title: Parental AdheRence of an Asynchronous Mobile hEalth Application for Children With Medical TEchnologies Using a Randomized Trial of Outpatient Nursing Care Models (PARAMETER)

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.

Read the detailed description

This proposal's overall objective is to evaluate the effectiveness of an enterprise-level outpatient nursing care model with an asynchronous mobile health platform for parents of children with medical complexity (CMC) age 0-3 years to communicate with their child's healthcare team via remote patient monitoring (RPM).

The researchers will evaluate the efficacy of a proactive nursing care model on 30-day readmissions (Aim 1), parental experience and managing their child's care at home (Aim 2), and healthcare team engagement frequency with a proactive outpatient nursing care model necessary to achieve adoption into outpatient models of care (Aim 3).

Being tested
CHAMP App
Keywords
mHealth, Software Platform, remote patient monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHAMP AppDevice

    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.

Study groups in NCT06672042
Study groupRoleWhat they receive
Proactive Nursing Care model using a mobile application and software platformExperimental* 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.
Receives: Device: CHAMP App
Standard of care control armNo 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 days

Secondary outcomes (5)

  1. Home Monitoring Data Adherence

    From study enrollment to 30 days after discharge- Remote health monitoring adherence (both arms) to daily data entry

    Measured: 30 days

  2. Length of Readmission

    Time measured in days of hospital readmission from admission to discharge, Any time of readmission during 30-day monitoring period

    Measured: 30 days

  3. Parental Experience

    At enrollment and 30 days after discharge: Parental Experience of discharge home after a hospitalization measured by the PACT-M tool at two-time points (enrollment at initial discharge and at 30 days). Along with the data for Aim 1, for the PACT-M tool 35. The PACT-M tool is a 9 item, reliable, validated tool with 5-point Likert answers (Appendix) (Strongly disagree to Agree Strongly). System usability survey questions will also be utilized for Arm 1 CHAMP App participants.

    Measured: 30 days

  4. Initiation Adherence

    First day of data documentation after discharge

    Measured: 30 days

  5. Discontinuation Adherence

    Last day of data documentation after discharge before end of study period

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2024
  2. Study startAug 2025 (estimated)
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Why it stopped: Study has been withdrawn/stopped as funding was not recieved. Therefore, study was never started (no participants enrolled).

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06672042
Sponsor's protocol ID
STUDY00003221
Acronym
PARAMETER
Status last verified
Apr 2025
First submitted
31 Oct 2024
Last updated
10 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The study team will make the data dictionary available on request

Publications

  • 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.

    PubMed 38340352

  • 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.

    PubMed 27166202

  • 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.

    PubMed 33591609

Questions about this trial

What is this clinical trial studying?

A study testing CHAMP App in people with Pediatrics and Medically Complex, run by Children's Mercy Hospital Kansas City at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Cause Readmission (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06672042, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in