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

Not Applicable

Recruiting

• Conditions: Understanding of Consent in Clinical Research; Implementation of Video-Consent in Clinical Research
• Interventions: Other: Usual Care; Other: ViDEO explaining study

• Registration Number: NCT06446492
• Lead Sponsor: The University of Texas Health Science Center, Houston

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-05-31
• Study First Posted: 2024-06-06
• Study Start: 2024-07-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care approach to consent	Usual Care	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.
Video-enhanced approach to consent	ViDEO explaining study	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.

Primary Outcome Measures

Name	Time	Method
Participants' understanding of the ViDES study as assessed by a questionnaire	Within 48 hours of the intervention	The questionnaire assesses recall of possible benefits and risks of participation.
Participants' satisfaction with consent approach as assessed by a questionnaire	Within 48 hours of the intervention	The questionnaire assesses satisfaction with ability to ask questions and decision time.
ViDES trial consent rate	Within 1 week of the intervention
Participant's opinions related to participation in research as assessed by a questionnaire	Within 48 hours of the intervention	The questionnaire assesses participant's opinions related to participation in research and research being part of the care of infants.

Trial Locations

Locations (1)

McGovern Medical School at UTHealth Houston; 🇺🇸 Houston, Texas, United States