COMPLETED

Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study

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

This pilot randomized controlled trial evaluates the impact of video-enhanced consent compared to the usual approach. The investigators aim to assess if video-enhanced consent empowers decision-making and improves understanding in parents considering participation in the ViDES study, which investigates the effectiveness of Vitamin D supplementation in extremely preterm infants (the ViDES study is separately registered as NCT05459298).

Official Title

Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study: A Randomized Controlled Trial

Quick Facts

Study Start:2024-07-01
Study Completion:2025-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06446492

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:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Parents/legal guardians of extremely preterm infants (\<28 weeks gestational age or \<1000 g birth weight) admitted to the Neonatal Intensive Care Unit at Children's Memorial Hermann hospital that qualify for the ViDES study (ViDES study is separately registered as NCT05459298)
  1. * Parents/legal guardians deaf or blind
  2. * Parents/legal guardians unable to consent for the VIDES study

Contacts and Locations

Principal Investigator

Maria del Mar Romero López, MD, MS, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at Houston (UTHealth Houston)

Study Locations (Sites)

McGovern Medical School at UTHealth Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Maria del Mar Romero López, MD, MS, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at Houston (UTHealth Houston)

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 Date2024-07-01
Study Completion Date2025-06-15

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2025-06-15

Terms related to this study

Additional Relevant MeSH Terms

  • Understanding of Consent in Clinical Research
  • Implementation of Video-Consent in Clinical Research