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Redesigning the Care Journey of Patients With Single-ventricle Congenital Heart Disease

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ClinicalTrials.gov Identifier: NCT04613934
Recruitment Status : Completed
First Posted : November 3, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Carlos Miguel Mery, University of Texas at Austin

Brief Summary:
In this three-party collaboration, which includes The Texas Center for Pediatric and Congenital Heart Disease, the Value Institute for Health and Care, and the Design Institute for Health, all from University of Texas (UT) Dell Medical School, the investigators will explore how patient insights, data, storytelling, ideation, and prototyping can be employed to design a care delivery solution that enables patient outcome improvement. The goal of this project is to understand the life journey of patients with single-ventricle congenital heart disease and understand areas of that journey that can be improved. As such, the project intentionally does not start with a hypothesis, but instead seeks to gain insight of single-ventricle patients' care journey and based on that understanding identify opportunities for improvement.

Condition or disease
Single-ventricle Congenital Heart Disease

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Study Type : Observational
Actual Enrollment : 142 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Redesigning the Care Journey of Patients With Single-ventricle Congenital Heart Disease
Actual Study Start Date : February 4, 2020
Actual Primary Completion Date : October 16, 2020
Actual Study Completion Date : October 16, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Identification of areas to be improved in patient and families' journey [ Time Frame: 2 years ]
    This is a qualitative research study. The investigators are using a combination of Experience Group sessions, Contextual Interviews and workshops with patients and their family members to obtain information to identify areas of the lifelong journey of patient with single-ventricle congenital heart disease and their families that can be redesigned to improve the outcomes that matter most to the patients and their families



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients and families of patients with single-ventricle congenital heart disease
Criteria

Inclusion Criteria:

  • Patients with any diagnosis of single-ventricle congenital heart disease, age 6 and older
  • Parents or legal guardians of patients at any age with any diagnosis of single-ventricle congenital heart disease
  • Siblings of patients with any diagnosis of single-ventricle congenital heart disease, age 6 and older
  • Pregnant parents who have gotten any prenatal diagnosis of single-ventricle congenital heart disease
  • Adult partners of adult patients with any diagnosis of single-ventricle congenital heart disease

Exclusion Criteria:

  • Patients with a cognitive disability that prevents completion of the study procedures
  • Patients, family members, and partners who do not speak English or Spanish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613934


Locations
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United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Carlos M Mery, MD, MPH University of Texas at Austin
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Responsible Party: Carlos Miguel Mery, Associate Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT04613934    
Other Study ID Numbers: 2019-08-0031
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlos Miguel Mery, University of Texas at Austin:
congenital heart disease
single-ventricle congenital heart disease
qualitative research
care experience
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Univentricular Heart
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities