PMID- 24216218 OWN - NLM STAT- MEDLINE DCOM- 20141204 LR - 20240321 IS - 1740-7753 (Electronic) IS - 1740-7745 (Print) IS - 1740-7745 (Linking) VI - 11 IP - 2 DP - 2014 Apr TI - Recruitment and retention of participants for an international type 1 diabetes prevention trial: a coordinators' perspective. PG - 150-8 LID - 10.1177/1740774513510070 [doi] AB - BACKGROUND: The Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken. A unique feature of TRIGR has been recruitment of eligible pregnant women and enrollment of newborns for long-term follow-up assessments. PURPOSE: Our purpose is to summarize the recruitment and retention strategies used to conduct TRIGR from the perspective of the study coordinators. METHODS: TRIGR was designed to test whether weaning to formula containing hydrolyzed versus intact cow's milk protein would be efficacious in decreasing risk for development of T1D-associated autoantibodies and T1D among infants identified to be at increased risk for T1D based on their human leukocyte antigen (HLA) profile and family history. Multiple strategies tailored to local issues were required to enroll and follow the target number of infants. RESULTS: This study was conducted in the United States, Canada, Australia, and 12 countries in Europe. Of the 5606 mothers registered worldwide, 5000 of their infants were randomized. Of these, 2159 were HLA eligible and enrolled in the 8-month intervention and 10-year follow-up phases of this study. The TRIGR study met the accrual goal after 4.7 years of recruitment, 2.7 years longer than projected initially. Challenges included difficulty in finding fathers with T1D, a higher than expected rate of premature delivery among T1D mothers, and implementation of new privacy regulations mid-trial. The majority of participants were recruited from primary care antenatal clinics located near the study centers and from a general hospital or pediatric center that was affiliated with a TRIGR Study center. Internet and magazine advertisements were found to be useful for recruitment of families. Alternative follow-up strategies are offered to families who wish to reduce or discontinue participation. LIMITATIONS: Our experience is limited to a single international multicenter trial. CONCLUSIONS: TRIGR coordinators played key roles in the recruitment and intervention periods and continue to be instrumental in retaining families and children during the 10-year follow-up period for each child. FAU - Franciscus, Margaret AU - Franciscus M AD - aDepartment of Pediatric Medicine, University of Pittsburgh, Pittsburgh, PA, USA. FAU - Nucci, Anita AU - Nucci A FAU - Bradley, Brenda AU - Bradley B FAU - Suomalainen, Heli AU - Suomalainen H FAU - Greenberg, Ellen AU - Greenberg E FAU - Laforte, Diane AU - Laforte D FAU - Kleemola, Paivi AU - Kleemola P FAU - Hyytinen, Mila AU - Hyytinen M FAU - Salonen, Marja AU - Salonen M FAU - Martin, Mary Jean AU - Martin MJ FAU - Catte, Daniel AU - Catte D FAU - Catteau, Jacki AU - Catteau J CN - TRIGR Investigators LA - eng SI - ClinicalTrials.gov/NCT00179777 GR - U01 HD042444/HD/NICHD NIH HHS/United States GR - HD051997/HD/NICHD NIH HHS/United States GR - U01 HD051997/HD/NICHD NIH HHS/United States GR - U01 HD040364/HD/NICHD NIH HHS/United States GR - R01 HD051997/HD/NICHD NIH HHS/United States GR - HD040364/HD/NICHD NIH HHS/United States GR - HD042444/HD/NICHD NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20131111 PL - England TA - Clin Trials JT - Clinical trials (London, England) JID - 101197451 RN - 0 (HLA Antigens) SB - IM MH - Adult MH - Australia MH - Canada MH - Diabetes Mellitus, Type 1/genetics/*prevention & control MH - Diet Therapy/*methods MH - Double-Blind Method MH - Europe MH - Female MH - HLA Antigens/genetics MH - Humans MH - Infant, Newborn MH - *International Cooperation MH - Male MH - Multicenter Studies as Topic/*methods MH - *Patient Selection MH - Pregnancy MH - Randomized Controlled Trials as Topic/*methods MH - *Research Personnel MH - United States PMC - PMC3972359 MID - NIHMS529299 FIR - Mandrup-Poulsen, T IR - Mandrup-Poulsen T FIR - Arjas, E IR - Arjas E FIR - Laara, E IR - Laara E FIR - Lernmark, A IR - Lernmark A FIR - Schmidt, B IR - Schmidt B FIR - Krischer, J P IR - Krischer JP FIR - Akerblom, H K IR - Akerblom HK FIR - Hyytinen, M IR - Hyytinen M FIR - Knip, M IR - Knip M FIR - Koski, K IR - Koski K FIR - Koski, M IR - Koski M FIR - Pajakkala, E IR - Pajakkala E FIR - Salonen, M IR - Salonen M FIR - Cuthbertson, D IR - Cuthbertson D FIR - 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Huopio, H IR - Huopio H FIR - Pensola, J IR - Pensola J FIR - Veijola, R IR - Veijola R FIR - Tapanainen, P IR - Tapanainen P FIR - Alar, A IR - Alar A FIR - Korpela, P IR - Korpela P FIR - Kaar, M-L IR - Kaar ML FIR - Mustila, T IR - Mustila T FIR - Virransalo, R IR - Virransalo R FIR - Nykanen, P IR - Nykanen P FIR - Aschemeier, B IR - Aschemeier B FIR - Danne, T IR - Danne T FIR - Kordonouri, O IR - Kordonouri O FIR - Krikovszky, D IR - Krikovszky D FIR - Madacsy, L IR - Madacsy L FIR - Khazrai, Ym IR - Khazrai Y FIR - Maddaloni, E IR - Maddaloni E FIR - Pozzilli, P IR - Pozzilli P FIR - Mannu, C IR - Mannu C FIR - Songini, M IR - Songini M FIR - de Beaufort, C IR - de Beaufort C FIR - Schierloh, U IR - Schierloh U FIR - Bruining, J IR - Bruining J FIR - Bisschoff, M IR - Bisschoff M FIR - Basiak, A IR - Basiak A FIR - Wasikowa, R IR - Wasikowa R FIR - Ciechanowska, M IR - Ciechanowska M FIR - Deja, G IR - Deja G FIR - Jarosz-Chobot, P IR - Jarosz-Chobot P FIR - Szadkowska, A IR - Szadkowska A FIR - 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White, N IR - White N FIR - Devaskar, U IR - Devaskar U FIR - Horowitz, H IR - Horowitz H FIR - Rogers, L IR - Rogers L FIR - Colon, R IR - Colon R FIR - Frazer, T IR - Frazer T FIR - Torres, J IR - Torres J FIR - Goland, R IR - Goland R FIR - Greenberg, E IR - Greenberg E FIR - Nelson, M IR - Nelson M FIR - Schachner, H IR - Schachner H FIR - Softness, B IR - Softness B FIR - Ilonen, J IR - Ilonen J FIR - Trucco, M IR - Trucco M FIR - Nichol, L IR - Nichol L FIR - Savilahti, E IR - Savilahti E FIR - Harkonen, T IR - Harkonen T FIR - Vaarala, O IR - Vaarala O FIR - Luopajarvi, K IR - Luopajarvi K EDAT- 2013/11/13 06:00 MHDA- 2014/12/15 06:00 PMCR- 2015/04/01 CRDT- 2013/11/13 06:00 PHST- 2013/11/13 06:00 [entrez] PHST- 2013/11/13 06:00 [pubmed] PHST- 2014/12/15 06:00 [medline] PHST- 2015/04/01 00:00 [pmc-release] AID - 1740774513510070 [pii] AID - 10.1177/1740774513510070 [doi] PST - ppublish SO - Clin Trials. 2014 Apr;11(2):150-8. doi: 10.1177/1740774513510070. Epub 2013 Nov 11.