COMPLETED

Exploration of Central Venous Catheter Protective Devices in the Pediatric Population: A Mixed Methods Study

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

1. to determine the feasibility of utilizing a wearable device 2. to prospectively measure and evaluate parent and nurse satisfaction with the protective wearable device. This is a sequential, convergent mixed methods study design in which qualitative interview data will be collected first followed by quantitative data. Scheme and Outcomes: Identify eligible patients--Informed Consent--Provide education and two protective wearable device--Demographic data (electronic health record)--Interview parent on device--Every month complete 30-day satisfaction survey for a total of three data collection period-Discharge from study. Nurse data collection scheme: Study participants hospitalized at time of enrollment in study or anytime during the study period. Nurse of patients using device will complete satisfaction survey. Note: Vest is a Class I Exempt FDA-registered device.

Official Title

Exploration of Central Venous Catheter Protective Devices in the Pediatric Population: A Mixed Methods Study

Quick Facts

Study Start:2022-12-14
Study Completion:2025-05-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05415449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patients with CVCs ages 0 to 12 years of age
  2. * May currently utilizing or historically utilized the interventional wearable protective device
  3. * Caregiver or parent available
  4. * English and Spanish speaking subjects
  1. * • Females with Tanner 2 breast or greater breast development. Justification: the wearable device will not fit properly to secure the CVC and may increase the risk of complications. If the patient does develop breast during the time of the study, then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. Tanner 2 breast development will be evaluated in the screening process of patients.
  2. * Patients in critical care services such as neonates, trauma/ neurology intensive care unit, or cardiac intensive care unit. Justification: These patients are not mobile with their CVC and not the targeted population.

Contacts and Locations

Principal Investigator

Maria Leal, BSN, RN, CPN
PRINCIPAL_INVESTIGATOR
Children's Health UTSW

Study Locations (Sites)

Children's Health
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Maria Leal, BSN, RN, CPN, PRINCIPAL_INVESTIGATOR, Children's Health UTSW

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-14
Study Completion Date2025-05-28

Study Record Updates

Study Start Date2022-12-14
Study Completion Date2025-05-28

Terms related to this study

Additional Relevant MeSH Terms

  • Central Line