Digital Media for Informed Consent
(WHEAT-Boost Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method for sharing information with families about joining a research study in NICUs. It aims to determine if a short digital video, called WHEAT-Boost Digital Video, can enhance parents' understanding of the study and make them more comfortable with the decision to participate. The study focuses on very premature infants (born before 30 weeks) involved in a larger trial about feeding and blood transfusions. Families with infants in Canadian NICUs participating in this larger study might be suitable candidates. The goal is to assess whether the video increases the number of families who choose to join and remain in the study. As an unphased trial, this study provides families the chance to contribute to important research that could improve communication and decision-making in NICUs.
What prior data suggests that this digital video is safe for improving informed consent in NICU research?
Research shows that digital tools for informed consent, such as the WHEAT-Boost Digital Video, can enhance understanding of medical information. One study found that using digital media during the consent process improved comprehension of clinical procedures and potential risks. As a result, people are more likely to understand what a trial involves when they have access to these resources.
The video in this study was designed to be simple and clear, aiding parents in grasping the research's importance and what participation entails. As a video, it poses no risk of physical side effects or adverse events, unlike medications or medical devices. The main goal is to simplify and enrich the consent process, particularly for parents who might feel overwhelmed in the NICU setting.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to improve how informed consent is given to participants in neonatal research. Unlike the traditional paper and verbal consent process, the WHEAT-Boost Digital Video provides an engaging and accessible way to explain important trial information. This digital approach is designed to enhance understanding by using a short, co-designed video that families can watch at their convenience. By making the consent process clearer and more informative, the trial hopes to boost participation and comprehension, ultimately improving the quality of neonatal research.
What evidence suggests that this digital video is effective for improving informed consent in neonatal research?
Research shows that digital media for informed consent can enhance understanding and decision-making. For example, studies have found that digital videos help parents in NICUs comprehend the importance and details of clinical trials. In one study, such a video aided parents in making informed choices about joining a research study on Vitamin D for very premature babies. These videos provide clear and simple explanations, potentially increasing study participation and satisfaction with the consent process. In this trial, participants in the Intervention (Video) Arm will receive the WHEAT-Boost digital video to supplement the usual consent documentation. Overall, early evidence suggests that the WHEAT-Boost digital video could simplify decision-making for families considering neonatal research participation.678910
Who Is on the Research Team?
Balpreet Singh
Principal Investigator
IWK Health
Are You a Good Fit for This Trial?
The WHEAT-Boost trial is for families with very premature infants (born before 30 weeks) in NICUs across Canada. It's designed to see if a digital video can help parents understand and feel more comfortable about enrolling their babies in neonatal research studies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive the usual informed consent or opt-out consent documentation plus access to a co-designed 3.5-4-minute digital media video that explains the importance of neonatal research and key trial details.
Follow-up
Participants are monitored for opt-in rate, withdrawal rate, and parental comprehension of trial-specific details.
What Are the Treatments Tested in This Trial?
Interventions
- WHEAT-Boost Digital Video
Trial Overview
This study tests whether a co-designed digital video, explaining the importance of NICU research, increases recruitment rates for the larger WHEAT International Trial. Sites are randomly assigned to use standard methods or add the video to their approach.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive the usual informed consent or opt-out consent documentation plus access to a co-designed 3.5-4-minute digital media video that explains the importance of neonatal research and key trial details in an accessible format. The video is intended to supplement and clarify the consent process to improve understanding and recruitment. Research staff provide parents/primary caregivers with a QR code linking to the video hosted on the WHEAT International Trial website. Families are encouraged to watch the video on their personal devices or hospital devices if needed. This is provided alongside the usual consent documentation during the NICU stay. Following this, families complete the same brief questionnaire about their experience and comprehension.
Participants receive the standard informed consent or opt-out consent documentation for the WHEAT International Trial without any additional digital media support. Research staff approach parents/primary caregivers using the usual verbal and paper-based consent process. Families then complete a brief questionnaire about their understanding and experience with the consent process.
Find a Clinic Near You
Who Is Running the Clinical Trial?
IWK Health Centre
Lead Sponsor
Citations
Examining the Efficacy of a Digital Media Intervention to ...
WHEAT-Boost is a Study Within A Trial (SWAT) that aims to improve how families are recruited into neonatal research studies by testing a new ...
2.
ctv.veeva.com
ctv.veeva.com/study/examining-the-efficacy-of-a-digital-media-intervention-to-increase-recruitment-ratesExamining the Efficacy of a Digital Media Intervention to ...
WHEAT-Boost is a Study Within A Trial (SWAT) that aims to improve how families are recruited into neonatal research studies by testing a new ...
Development of Patient Centered Virtual Multimedia ...
For patients to fully understand the content of the informed consent process, it should clearly explain the purpose, process, risks, benefits and alternatives ...
Digital Informed Consent/Assent in Clinical Trials Among ...
This study evaluates the effectiveness of electronic IC (eIC) materials developed under these guidelines for 3 target populations—minors, ...
5.
withpower.com
withpower.com/trial/phase-implementation-of-video-consent-in-clinical-research-6-2024-4563fVideo-Consent for Informed Decision-Making
This trial tests whether watching a video can help parents make better decisions about joining a study on Vitamin D for very premature babies.
Digitalizing informed consent in healthcare: a scoping review
The findings suggest that digitalizing the consent process can enhance recipients' understanding of clinical procedures, potential risks and ...
Informed Consent for Research Using Digital Health ...
This resource provides points to consider and sample language for informed consent of research studies which plan to use digital health technologies.
Time to discuss consent in digital-data studies
Anonymized data sets are growing and it is becoming easier to identify individuals. Research-consent procedures must be updated to protect people from being ...
9.
subscriber.politicopro.com
subscriber.politicopro.com/article/2025/12/hhs-launches-new-ai-initiative-00677236POLITICO Pro | Article | HHS launches new AI initiative
HHS launches new AI initiative ... The plan is part of a larger mission at the department to use AI to improve health outcomes for Americans.
Public health interventions to address digital determinants ...
We summarise three groups of public health interventions that can help delay media use among very young children, reduce digital media use among children of ...
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