Recruitment and retention of participants for an international type 1 diabetes prevention trial: A coordinators’ perspective

Abstract

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 vs. 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 The study was conducted in the United States, Canada, Australia and 12 countries in Europe. Of the 5,606 mothers registered world-wide, 5,000 of their infants were randomized. Of these, 2,159 were HLA eligible and enrolled in the 8-month intervention and 10-year follow-up phases of the 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 amongst 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.

Ethical issues in using the internet to engage participants in family and child research: A scoping review

“…For the retention of participants in longitudinal research, five studies used email to keep in contact ( n = 5/7, 71%), one used a study website and one became ‘friends’ with participants on Facebook. Four studies ( n = 4/7, 57%) employed both offline (e.g., mail, phone, SMS) and online retention methods [ 34 , 41 – 43 ]. Again, the success of online versus offline methods for retaining participants was poorly reported.…”

“…Only one study provided details on retention rates using email reminders and a subsequent mail-out to non-responders [ 34 ] and concluded that multiple reminders using online and offline modes of contact improved overall response rates. Two studies reported retention rates of the cohort overall, rather than by the method used to maintain contact [ 41 , 42 ] and one study did not report retention rates, yet remarked that Facebook was a more effective retention tool than email [ 43 ].…”

Recruiting young pre-symptomatic children for a clinical trial in type 1 diabetes: Insights from the Fr1da insulin intervention study

“…Taken together participation in the Fr1da Insulin Intervention study might result in an improved medical care [ [20] , [21] , [22] ]. Also, the intervention with high-dose oral insulin was shown to be safe in the Pre-POINT study [ 12 ], in the Pre-POINT Early study ( clinicaltrials.gov NCT02547519 ) and in the TrialNet TN20 trial ( clinicaltrials.gov NCT02580877 ) using an even higher dose (ADA oral presentation 2017). Thus it seems surprising that almost half of the parents of eligible children who were informed of the study did not enroll their children.…”

“…Recruitment strategies [ 10 ] and participant characteristics that predict recruitment are rarely reported [ 11 ]. For preventive trials in asymptomatic children the problem of slow recruitment seems to be even more evident [ 12 ] but not much information is available on this topic.…”

Sugarsquare, a Web-Based Patient Portal for Parents of a Child With Type 1 Diabetes: Multicenter Randomized Controlled Feasibility Trial

“…It could be that the questionnaires, which had to be filled in by the parents on several occasions, discouraged potential participants [ 54 ]. It is also possible that, due to the research context, parents perceived this study as an externally driven project, which conflicted with their preference for a center-driven intervention [ 8 ] and might have negatively influenced their willingness to cooperate [ 55 ]. Our study was further confronted with an average postrandomization attrition rate during follow-up (26% vs 0-54%, mean 20% in Karlson and Rapoff) [ 34 , 53 ].…”