Understanding of Consent in Clinical ResearchNCT06446492
Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study
A study testing ViDEO explaining study in people with Understanding of Consent in Clinical Research and Implementation of Video-Consent in Clinical Research, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Understanding of Consent in Clinical Research, Implementation of Video-Consent in Clinical Research
- What is being tested?
- ViDEO explaining study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Parents/legal guardians deaf or blind
- Parents/legal guardians unable to consent for the VIDES study
Trial locations and contacts
1 site in 1 country.
United States1 site
McGovern Medical School at UTHealth Houston
Houston, Texas, 77030
About this study
Official 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
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
- Understanding of Consent in Clinical Research, Implementation of Video-Consent in Clinical Research
- Being tested
- ViDEO explaining study, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViDEO explaining studyOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ViDEO explaining study |
| 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ViDES trial consent rate
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 48 hours of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Jul 2024
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Understanding of Consent in Clinical ResearchStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria del Mar Romero López, The University of Texas Health Science Center, Houston
- Investigators
- Maria del Mar Romero López, MD, MS, PhD, Principal investigator, The University of Texas Health Science Center at Houston (UTHealth Houston)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446492
- Sponsor's protocol ID
- HSC-MS-22-0563 (sub-study)
- Status last verified
- Dec 2024
- First submitted
- 31 May 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06446492
- Acronym / sponsor ID
- HSC-MS-22-0563 (sub-study)
- Conditions
- Understanding of Consent in Clinical Research, Implementation of Video-Consent in Clinical Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-enhanced approach to consent | Experimental | Other: ViDEO explaining studyThe 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 approach to consent | Active comparator | Other: Usual CareThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- Parents/legal guardians deaf or blind
- Parents/legal guardians unable to consent for the VIDES study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViDEO explaining studyThe 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 | Video-enhanced approach to consent |
| Usual CareThe 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. | Other | Usual care approach to consent |
Primary outcome
ViDES trial consent rate
Time frame: Within 1 week of the intervention
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria del Mar Romero López, MD, MS, PhD principal investigator
The University of Texas Health Science Center at Houston (UTHealth Houston)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ViDEO explaining study in people with Understanding of Consent in Clinical Research and Implementation of Video-Consent in Clinical Research, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ViDES trial consent rate (time frame: Within 1 week of the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.