Examining the Efficacy of a Parent-targeted Co-designed Digital Media Intervention to Increase Recruitment Rates Across a Multi-site Randomized Clinical Trial in Canadian NICU's

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Maximum Age: 7 months
Healthy Volunteers: f
View:

• Infant meets eligibility criteria for the WHEAT International Trial

• Infant is \<30 weeks gestational age at birth

• Infant is admitted to one of the participating Canadian NICU sites

• Parent(s)/primary caregiver(s) are approached for consent to participate in the WHEAT Trial during a time period when the SWAT is active at their site

Locations
Other Locations
Canada
Royal Alexandra Hospital
RECRUITING
Edmonton
Dr. Everett Chalmers
RECRUITING
Fredericton
IWK Health
RECRUITING
Halifax
Kingston Health Sciences Centre
RECRUITING
Kingston
Centre hospitalier de l'Université Laval
RECRUITING
Laval
London Health Sciences Centre
RECRUITING
London
Moncton Hospital
RECRUITING
Moncton
Montreal Children's Hospital
RECRUITING
Montreal
The Ottawa Hospital/CHEO
RECRUITING
Ottawa
Saint John Regional Hospital
RECRUITING
Saint John
Janeway Children's Health and Rehabilitation Centre
RECRUITING
Saint Johns
Centre hospitalier universitaire de Sherbrooke
RECRUITING
Sherbrooke
Mount Sinai
RECRUITING
Toronto
BC Women's Hospital and Health Centre
RECRUITING
Vancouver
Windsor Regional Hospital
RECRUITING
Windsor
Contact Information
Primary
Cari-Lee Carnell
cari-lee.carnell@iwk.nshealth.ca
902-219-2216
Backup
Tara Hatfield
tara.hatfield@iwk.nshealth.ca
902-219-2216
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 787
Treatments
No_intervention: Control (No-Video) Arm
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.
Experimental: Intervention (Video) Arm
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.
Related Therapeutic Areas
Sponsors
Leads: IWK Health Centre

This content was sourced from clinicaltrials.gov