Trials / Completed
CompletedNCT06446492
Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study
Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study: A Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 83 (actual)
- Sponsor
- The University of Texas Health Science Center, Houston · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
| OTHER | 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. |
Timeline
- Start date
- 2024-07-01
- Primary completion
- 2025-06-15
- Completion
- 2025-06-15
- First posted
- 2024-06-06
- Last updated
- 2025-06-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06446492. Inclusion in this directory is not an endorsement.