[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614802":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":32,"studyPopulation":25,"armGroups":33,"interventions":44,"overallOfficials":49,"centralContacts":54,"locations":63,"responsibleParty":189,"collaborators":25,"id":192,"slug":25,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":193,"sex":199,"minAge":25,"maxAge":200,"enrollmentInfo":201,"targetDuration":25,"studyType":204,"phases":205,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":66,"whyStopped":25,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"IWK Health Centre","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"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))",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Trial Withdrawal Rate (Post-Randomization)","The proportion of enrolled participants who withdraw from the WHEAT International Trial after randomization.","Birth to 40 weeks Post Menstrual Age (From enrollment until study completion)",{"measure":19,"description":20,"timeFrame":21},"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.","Baseline (Once family makes the consent decision - Within first two weeks of life)",{"measure":23,"description":24,"timeFrame":21},"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.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":6,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","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.",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE","WHEAT-Boost is a stepped-wedge cluster randomized SWAT embedded within the ongoing WHEAT International Trial (NCT05213806), which evaluates feeding practices around blood transfusion in preterm infants. The SWAT aims to examine whether the addition of a co-designed digital media intervention improves recruitment outcomes, parental comprehension, and satisfaction with the research consent process in the NICU setting.\n\nFifteen Canadian NICUs participating in the WHEAT International Trial will be randomized in a stepped-wedge design to transition from the control condition (usual recruitment approach) to the intervention condition (usual approach plus video). Each site will act as its own control, with transitions occurring at 29-day intervals. All sites will begin in the control arm, using standard informed or opt-out consent materials, and then sequentially implement the video intervention according to the randomized schedule.\n\nThe intervention consists of a 3.5- to 4-minute digital video co-developed with a parent-partner advisory group. The video uses accessible language, storytelling, and visual elements to highlight the role and value of neonatal research and to clarify key details of the WHEAT Trial. It is delivered via a QR code linked to a secure website, enabling families to view the content on personal or institutional devices. The co-design approach ensures the material is tailored to the needs and concerns of NICU families, many of whom may experience emotional distress and information overload during their infant's hospitalization.\n\nThis SWAT will evaluate several outcomes. The primary outcome is the WHEAT Trial opt-in rate, defined as the proportion of eligible families who consent to enroll their infant in the trial. Secondary outcomes include the post-randomization withdrawal rate, parental comprehension of trial-specific information, and overall experience with the consent process. These will be measured using a brief questionnaire co-designed with the parent group and administered to all approached families, regardless of group assignment.\n\nAnalysis of the primary and secondary outcomes will follow intention-to-treat principles and will use generalized linear mixed models appropriate for the stepped-wedge design. Models will include random intercepts for sites and fixed effects for time and intervention status. For qualitative data from open-ended survey responses, an inductive thematic analysis approach will be applied.\n\nThis SWAT addresses a critical need for evidence-based strategies to enhance trial recruitment in high-stress clinical environments like the NICU. By supplementing conventional consent procedures with engaging, accessible media, the study seeks to normalize research participation and support informed decision-making by parents of vulnerable infants. If effective, this low-cost, scalable intervention could be readily adapted to other trials and clinical settings, advancing broader efforts to improve inclusivity and transparency in neonatal research.",[34,38],{"label":35,"type":36,"description":37,"interventionNames":25},"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\u002Fprimary 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.",{"label":39,"type":40,"description":41,"interventionNames":42},"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.\n\nResearch staff provide parents\u002Fprimary 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.",[43],"Behavioral: Intervention (Video) Arm",[45],{"type":46,"name":39,"description":47,"armGroupLabels":48,"otherNames":25},"BEHAVIORAL","A 3.5-4-minute co-designed digital media video created to supplement the standard consent process for the WHEAT International Trial.",[39],[50],{"name":51,"affiliation":52,"role":53},"Balpreet Singh","IWK Health","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":25,"email":59},"Cari-Lee Carnell","CONTACT","902-219-2216","cari-lee.carnell@iwk.nshealth.ca",{"name":61,"role":57,"phone":58,"phoneExt":25,"email":62},"Tara Hatfield","tara.hatfield@iwk.nshealth.ca",[64,77,86,95,103,111,115,123,132,140,148,156,164,173,181],{"facility":65,"status":66,"city":67,"state":68,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":25},"Royal Alexandra Hospital","RECRUITING","Edmonton","Alberta","Canada","CA",{"type":72,"coordinates":73},"Point",[74,75],-113.46871,53.55014,{"lat":75,"lon":74},{"facility":78,"status":66,"city":79,"state":80,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":81,"geoPoint":85,"contacts":25},"BC Women's Hospital and Health Centre","Vancouver","British Columbia",{"type":72,"coordinates":82},[83,84],-123.11934,49.24966,{"lat":84,"lon":83},{"facility":87,"status":66,"city":88,"state":89,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":90,"geoPoint":94,"contacts":25},"Dr. Everett Chalmers","Fredericton","New Brunswick",{"type":72,"coordinates":91},[92,93],-66.66558,45.94541,{"lat":93,"lon":92},{"facility":96,"status":66,"city":97,"state":89,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":98,"geoPoint":102,"contacts":25},"Moncton Hospital","Moncton",{"type":72,"coordinates":99},[100,101],-64.7965,46.09454,{"lat":101,"lon":100},{"facility":104,"status":66,"city":105,"state":89,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":106,"geoPoint":110,"contacts":25},"Saint John Regional Hospital","Saint John",{"type":72,"coordinates":107},[108,109],-66.05616,45.27076,{"lat":109,"lon":108},{"facility":112,"status":66,"city":113,"state":114,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Janeway Children's Health and Rehabilitation Centre","Saint Johns","NFLD",{"facility":52,"status":66,"city":116,"state":117,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":118,"geoPoint":122,"contacts":25},"Halifax","Nova Scotia",{"type":72,"coordinates":119},[120,121],-63.57688,44.64269,{"lat":121,"lon":120},{"facility":124,"status":66,"city":125,"state":126,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":127,"geoPoint":131,"contacts":25},"Kingston Health Sciences Centre","Kingston","Ontario",{"type":72,"coordinates":128},[129,130],-76.48098,44.22976,{"lat":130,"lon":129},{"facility":133,"status":66,"city":134,"state":126,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":135,"geoPoint":139,"contacts":25},"London Health Sciences Centre","London",{"type":72,"coordinates":136},[137,138],-81.23304,42.98339,{"lat":138,"lon":137},{"facility":141,"status":66,"city":142,"state":126,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":143,"geoPoint":147,"contacts":25},"The Ottawa Hospital\u002FCHEO","Ottawa",{"type":72,"coordinates":144},[145,146],-75.69812,45.41117,{"lat":146,"lon":145},{"facility":149,"status":66,"city":150,"state":126,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":151,"geoPoint":155,"contacts":25},"Mount Sinai","Toronto",{"type":72,"coordinates":152},[153,154],-79.39864,43.70643,{"lat":154,"lon":153},{"facility":157,"status":66,"city":158,"state":126,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":159,"geoPoint":163,"contacts":25},"Windsor Regional Hospital","Windsor",{"type":72,"coordinates":160},[161,162],-83.01654,42.30008,{"lat":162,"lon":161},{"facility":165,"status":66,"city":166,"state":167,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":168,"geoPoint":172,"contacts":25},"Centre hospitalier de l'Université Laval","Laval","Quebec",{"type":72,"coordinates":169},[170,171],-73.692,45.56995,{"lat":171,"lon":170},{"facility":174,"status":66,"city":175,"state":167,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":176,"geoPoint":180,"contacts":25},"Montreal Children's Hospital","Montreal",{"type":72,"coordinates":177},[178,179],-73.58781,45.50884,{"lat":179,"lon":178},{"facility":182,"status":66,"city":183,"state":167,"zip":25,"country":69,"countryCode":70,"cosmosGeoPoint":184,"geoPoint":188,"contacts":25},"Centre hospitalier universitaire de Sherbrooke","Sherbrooke",{"type":72,"coordinates":185},[186,187],-71.89908,45.40008,{"lat":187,"lon":186},{"type":53,"investigatorFullName":190,"investigatorTitle":191,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Dr. Balpreet Singh","Associate Professor, Neonatologist","100614802",false,"NCT07284329","Examining the Efficacy of a Digital Media Intervention to Increase Recruitment Rates","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","WHEAT-Boost","Inclusion Criteria (applied to infants\u002Fparticipants in WHEAT Trial):\n\nInfant meets eligibility criteria for the WHEAT International Trial\n\nInfant is \\\u003C30 weeks gestational age at birth\n\nInfant is admitted to one of the participating Canadian NICU sites\n\nParent(s)\u002Fprimary caregiver(s) are approached for consent to participate in the WHEAT Trial during a time period when the SWAT is active at their site\n\nExclusion Criteria:\n\nInfant or family ineligible for participation in the WHEAT International Trial\n\nParent(s)\u002Fprimary 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)","ALL","30 Weeks",{"count":202,"type":203},787,"ESTIMATED","INTERVENTIONAL",[206],"NA","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).\n\nRecruiting 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.\n\nTo 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.\n\nNICU 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.\n\nThe 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.\n\nIf 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.",[209],"Consent Process",[211,212,213,214,215,216],"Consent","Neonatal research","Family questionnaires","Digital media","Co-design","Study video","2025-12-02",{"date":219,"type":220},"2025-12-16","ACTUAL",{"date":222,"type":220},"2025-01-06",{"date":224,"type":203},"2026-04-30",{"name":5,"class":6},15]