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

NCT07284329 | Recruiting

• 2 other identifiers: 1027137 (SWAT)CTR-184893/ CT1-184892
• Study Type: interventional
• Target: 787
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Consent Process

Keywords

Consent; Neonatal research; Family questionnaires; Digital media; Co-design; Study video

Outcome Measures

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.

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

Secondary Outcomes (3)

• Trial Withdrawal Rate (Post-Randomization)

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

• Parental Comprehension of Trial-Specific Details

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

• Parental Experience with the Consent Process

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

Study Arms (2)

Control (No-Video) Arm

NO INTERVENTION

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.

Intervention (Video) Arm

EXPERIMENTAL

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.

Behavioral: Intervention (Video) Arm

Interventions

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.

Intervention (Video) Arm

Eligibility Criteria

• Age: Up to 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Infant or family ineligible for participation in the WHEAT International Trial
• Parent(s)/primary caregiver(s) not approached for WHEAT Trial participation (e.g., missed recruitment window, language barriers not addressed by materials, medical instability of infant or family)

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (15)

Royal Alexandra Hospital

Edmonton, Alberta, Canada

RECRUITING

BC Women's Hospital and Health Centre

Vancouver, British Columbia, Canada

RECRUITING

Dr. Everett Chalmers

Fredericton, New Brunswick, Canada

RECRUITING

Moncton Hospital

Moncton, New Brunswick, Canada

RECRUITING

Saint John Regional Hospital

Saint John, New Brunswick, Canada

RECRUITING

Janeway Children's Health and Rehabilitation Centre

Saint Johns, NFLD, Canada

RECRUITING

IWK Health

Halifax, Nova Scotia, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, Canada

RECRUITING

The Ottawa Hospital/CHEO

Ottawa, Ontario, Canada

RECRUITING

Mount Sinai

Toronto, Ontario, Canada

RECRUITING

Windsor Regional Hospital

Windsor, Ontario, Canada

RECRUITING

Centre hospitalier de l'Université Laval

Laval, Quebec, Canada

RECRUITING

Montreal Children's Hospital

Montreal, Quebec, Canada

RECRUITING

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

RECRUITING

Related Publications (11)

• Lawrence LM, Bishop A, Curran J. Integrated Knowledge Translation with Public Health Policy Makers: A Scoping Review. Healthc Policy. 2019 Feb;14(3):55-77. doi: 10.12927/hcpol.2019.25792.

  PMID: 31017866 BACKGROUND

• Korstjens I, Moser A. Series: Practical guidance to qualitative research. Part 4: Trustworthiness and publishing. Eur J Gen Pract. 2018 Dec;24(1):120-124. doi: 10.1080/13814788.2017.1375092. Epub 2017 Dec 5.

  PMID: 29202616 BACKGROUND

• Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.

  PMID: 18352969 BACKGROUND

• Ouyang Y, Karim ME, Gustafson P, Field TS, Wong H. Explaining the variation in the attained power of a stepped-wedge trial with unequal cluster sizes. BMC Med Res Methodol. 2020 Jun 24;20(1):166. doi: 10.1186/s12874-020-01036-5.

  PMID: 32580698 BACKGROUND

• Voldal EC, Hakhu NR, Xia F, Heagerty PJ, Hughes JP. swCRTdesign: An RPackage for Stepped Wedge Trial Design and Analysis. Comput Methods Programs Biomed. 2020 Nov;196:105514. doi: 10.1016/j.cmpb.2020.105514. Epub 2020 May 21.

  PMID: 32554025 BACKGROUND

• Synnot A, Ryan R, Prictor M, Fetherstonhaugh D, Parker B. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database Syst Rev. 2014 May 9;2014(5):CD003717. doi: 10.1002/14651858.CD003717.pub3.

  PMID: 24809816 BACKGROUND

• Ballard HO, Shook LA, Desai NS, Anand KJ. Neonatal research and the validity of informed consent obtained in the perinatal period. J Perinatol. 2004 Jul;24(7):409-15. doi: 10.1038/sj.jp.7211142.

  PMID: 15152271 BACKGROUND

• Wilman E, Megone C, Oliver S, Duley L, Gyte G, Wright JM. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research. Trials. 2015 Nov 4;16:502. doi: 10.1186/s13063-015-0957-x.

  PMID: 26537492 BACKGROUND

• Dahav P, Sjostrom-Strand A. Parents' experiences of their child being admitted to a paediatric intensive care unit: a qualitative study-like being in another world. Scand J Caring Sci. 2018 Mar;32(1):363-370. doi: 10.1111/scs.12470. Epub 2017 Aug 22.

  PMID: 28833379 BACKGROUND

• Obeidat HM, Bond EA, Callister LC. The parental experience of having an infant in the newborn intensive care unit. J Perinat Educ. 2009 Summer;18(3):23-9. doi: 10.1624/105812409X461199.

  PMID: 20514124 BACKGROUND

• Al Maghaireh DF, Abdullah KL, Chan CM, Piaw CY, Al Kawafha MM. Systematic review of qualitative studies exploring parental experiences in the Neonatal Intensive Care Unit. J Clin Nurs. 2016 Oct;25(19-20):2745-56. doi: 10.1111/jocn.13259. Epub 2016 Jun 3.

  PMID: 27256250 BACKGROUND

MeSH Terms

Interventions

Methods; Videotape Recording

Intervention Hierarchy (Ancestors)

Investigative Techniques; Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Balpreet Singh

  IWK Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cari-Lee Carnell

CONTACT

902-219-2216; cari-lee.carnell@iwk.nshealth.ca

Tara Hatfield

CONTACT

902-219-2216; tara.hatfield@iwk.nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Neonatologist

Model Details: This study uses a stepped-wedge cluster randomized design, where participating NICU sites transition sequentially from the control (usual consent process) to the intervention (usual process plus digital media video) at randomized time points. Individual participants are exposed to only one condition based on the timing of their enrollment, making the study function as a parallel assignment design at the participant level.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 16, 2025
• Study Start: January 6, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 30, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CA (15)