NCT04498728

Brief Summary

This repository will consist of clinically derived data and images of patients with congenital heart disease from the time of birth until they have reached one of the following outcomes: transition to outpatient care that has not resulted in readmission in 30 days after hospital discharge, death, weaned off supplementary feeding tubes, or clinic visits demonstrating clinical stability with their primary cardiologist, or full bi-ventricular cardiac surgery palliation with improvement in hemodynamic stability. This information will be collected for clinical evaluation and diagnostic purposes and will continue to be stored for potential future research application.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

July 30, 2020

Last Update Submit

November 16, 2021

Conditions

Keywords

congenital heart disease

Outcome Measures

Primary Outcomes (2)

  • Number of children that had 30 day survival after hospital discharge

    Survival of child after hospital discharge

    1 month

  • Number of children that had Readmission after initiation hospital discharge

    Hospital readmission after initial discharge

    2 months

Interventions

The use of the CATCH application (CATCH App), and any data and images obtained from the use of the CATCH App, will all be performed as standard of care for patients at Children's Mercy Kansas City, and will be for the clinical treatment of patients. Data will be collected for the repository for all patients submitting data through the use of the CATCH App. Clinical care team will follow the patients after discharge home from the hospital.

Also known as: CHAMP

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children after hospitalization for heart surgery that required ICU care

You may qualify if:

  • Subjects with congenital heart disease that have been hospitalized for more than 30 days,
  • Subjects being discharged with readmissions more than twice to critical care areas,
  • Subject with single ventricle physiology that has not been discharged home during the single ventricle interstage period,
  • Subjects that are less than 18 years of age,
  • Subjects with gastrostomy or nasogastric tubes and congenital heart disease,
  • Subjects at high risk for events as identified by the Directors of the CATCH app Repository.

You may not qualify if:

  • All patients not meeting at least one of the above specified criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Related Publications (3)

  • 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.

  • Lushaj EB, Hermsen J, Leverson G, MacLellan-Tobert SG, Nelson K, Amond K, Anagnostopoulos PV. Beyond 30 Days: Analysis of Unplanned Readmissions During the First Year Following Congenital Heart Surgery. World J Pediatr Congenit Heart Surg. 2020 Mar;11(2):177-182. doi: 10.1177/2150135119895212.

  • Bingler M, Erickson LA, Reid KJ, Lee B, O'Brien J, Apperson J, Goggin K, Shirali G. Interstage Outcomes in Infants With Single Ventricle Heart Disease Comparing Home Monitoring Technology to Three-Ring Binder Documentation: A Randomized Crossover Study. World J Pediatr Congenit Heart Surg. 2018 May;9(3):305-314. doi: 10.1177/2150135118762401.

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Lori Erickson, PhD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 4, 2020

Study Start

July 29, 2020

Primary Completion

May 29, 2021

Study Completion

November 15, 2021

Last Updated

November 18, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations