Examining the Efficacy of a Digital Media Intervention to Increase Recruitment Rates

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorIWK Health Centre

About this trial

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 way of sharing information. The study is embedded within the larger WHEAT International Trial, a randomized clinical trial being conducted in Neonatal Intensive Care Units (NICUs) across Canada. The WHEAT International Trial investigates the best way to manage feeding around the time of blood transfusions in very premature infants (born before 30 weeks of pregnancy).

Recruiting families for research in the NICU is challenging. Parents are often stressed, overwhelmed, and unfamiliar with how clinical trials work, which can make it hard for them to process complex medical information and decide whether to take part. Traditional consent methods, such as paper forms, may not be enough to ensure families feel informed and comfortable with participation.

To address this, WHEAT-Boost will test whether adding a short, co-designed digital video helps improve recruitment rates. The video is 3.5 to 4 minutes long, available in English and French (with subtitles in other commonly spoken languages), and explains the importance of NICU research and details of the WHEAT International Trial in a simple and visual way. The video was co-developed with parents who have experience in the NICU to ensure the information is relevant and easy to understand.

NICU sites participating in the WHEAT Trial will be randomly assigned, in a stepped-wedge design schedule, to either continue using their usual recruitment methods, or to add the digital video to their recruitment approach. Parents in both groups will be asked to complete a short, voluntary questionnaire about their experience with the consent process and their understanding of the trial.

The main goal of WHEAT-Boost is to see if the video increases the number of families who agree to take part in the WHEAT Trial (known as the "opt-in rate"). The study will also look at whether the video reduces the number of families who later withdraw from the trial, and whether it improves parents' understanding of the study and their satisfaction with how information was shared.

If successful, the video could be used in other NICUs or future studies to help make research more accessible and inclusive for families. This approach could lead to stronger participation in neonatal trials, better-informed decisions by parents, and faster progress in improving care for premature babies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention (Video) Arm

    Behavioral

    A 3.5-4-minute co-designed digital media video created to supplement the standard consent process for the WHEAT International Trial.

Treatment groups

787 Participants
are divided into 2 treatment groups
Group A: Control (No-Video) ArmNo intervention 0 interventions
Group B: Intervention (Video) ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Opt-in Rate for the WHEAT International Trial

The proportion of families approached for participation in the WHEAT International Trial who provide consent (or do not opt out, depending on the site's consent model) for their infant to be enrolled.

Time frame
Baseline (When the family is approached for the Study Participation - Within first two weeks of life))

Secondary outcomes

1

Trial Withdrawal Rate (Post-Randomization)

The proportion of enrolled participants who withdraw from the WHEAT International Trial after randomization.

Time frame
Birth to 40 weeks Post Menstrual Age (From enrollment until study completion)
2

Parental Comprehension of Trial-Specific Details

Degree to which parents understand key elements of the WHEAT International Trial, assessed via a brief questionnaire co-designed with a parent-partner group.

Time frame
Baseline (Once family makes the consent decision - Within first two weeks of life)
3

Parental Experience with the Consent Process

Parents' perceptions of the clarity, helpfulness, and adequacy of the information provided during the consent process, collected via a brief, co-designed questionnaire.

Time frame
Baseline (Once family makes the consent decision - Within first two weeks of life)

Other outcomes

Sponsors and contacts

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