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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria del Mar Romero López, MD, MS, PhD | The University of Texas Health Science Center at Houston (UTHealth Houston) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGovern Medical School at UTHealth Houston | Houston | Texas | 77030 | United States |
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| 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. |
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