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NCT Number: NCT06446492

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

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).

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGovern Medical School at UTHealth Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. ViDES trial consent rate

    Time frame: Within 1 week of the intervention

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

    Time frame: Within 48 hours of the intervention

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

  3. Participants' satisfaction with consent approach as assessed by a questionnaire

    Time frame: Within 48 hours of the intervention

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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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