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

NCT06446492 | Completed

• 1 other identifier: HSC-MS-22-0563 (sub-study)
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Outcome Measures

Primary Outcomes (4)

• ViDES trial consent rate

  Within 1 week of the intervention

• Participants' understanding of the ViDES study as assessed by a questionnaire

  The questionnaire assesses recall of possible benefits and risks of participation.

  Within 48 hours of the intervention

• Participants' satisfaction with consent approach as assessed by a questionnaire

  The questionnaire assesses satisfaction with ability to ask questions and decision time.

  Within 48 hours of the intervention

• Participant's opinions related to participation in research as assessed by a questionnaire

  The questionnaire assesses participant's opinions related to participation in research and research being part of the care of infants.

  Within 48 hours of the intervention

Study Arms (2)

Video-enhanced approach to consent

EXPERIMENTAL

The research team will introduce themselves and ask the parents to watch an informational video explaining the ViDES study on an iPad while they stay in the room with the parents. After viewing the video, the team will answer any questions and provide written consent and enough time to decide whether to participate in the study. The research team will also provide a QR code that grants parents/guardians access to the video on their own device at any time. This allows them to pause, rewind, and revisit the information.

Other: ViDEO explaining study

Usual care approach to consent

ACTIVE COMPARATOR

The research team will present a detailed explanation of the ViDES study, answer questions, provide written consent, and provide enough time to decide on participation or not in the study.

Other: Usual Care

Interventions

ViDEO explaining study OTHER

The research team will introduce themselves and ask the parents to watch an informational video explaining the ViDES study on an iPad while they stay in the room with the parents. After viewing the video, the team will answer any questions and provide written consent and enough time to decide whether to participate in the study. The research team will also provide a QR code that grants parents/guardians access to the video on their own device at any time. This allows them to pause, rewind, and revisit the information.

Video-enhanced approach to consent

Usual Care OTHER

The research team will present a detailed explanation of the ViDES study, answer questions, provide written consent, and provide enough time to decide on participation or not in the study.

Usual care approach to consent

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Parents/legal guardians deaf or blind
• Parents/legal guardians unable to consent for the VIDES study

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

McGovern Medical School at UTHealth Houston

Houston, Texas, 77030, United States

Location

Study Officials

• Maria del Mar Romero López, MD, MS, PhD

  The University of Texas Health Science Center at Houston (UTHealth Houston)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: July 1, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: June 26, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)