Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 83
- Locations
- 2
- Primary Endpoint
- Participants' understanding of the ViDES study as assessed by a questionnaire
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
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.
ViDES trial consent rate
Time Frame: Within 1 week of the intervention
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Maria del Mar Romero López
Assistant Professor
The University of Texas Health Science Center, Houston