TY - JOUR
T1 - Participant recruitment into a community-based diabetes prevention trial in India
T2 - Learnings from the Kerala Diabetes Prevention Program
AU - Sathish, Thirunavukkarasu
AU - Aziz, Zahra
AU - Absetz, Pilvikki
AU - Thankappan, Kavumpurathu Raman
AU - Tapp, Robyn Jennifer
AU - Balachandran, Sajitha
AU - Shetty, Suman Surendra
AU - Oldenburg, Brian
PY - 2019/9
Y1 - 2019/9
N2 - Background: Data on participant recruitment into diabetes prevention trials are limited in low- and middle-income countries (LMICs). We aimed to provide a detailed analysis of participant recruitment into a community-based diabetes prevention trial in India.Methods: The Kerala Diabetes Prevention Program was conducted in 60 polling areas (electoral divisions) of the Neyyatinkara taluk (subdistrict) in Trivandrum district, Kerala state. Individuals (age 30-60 years) were screened with the Indian Diabetes Risk Score (IDRS) at their homes followed by an oral glucose tolerance test (OGTT) at community-based clinics. Individuals at high-risk of developing diabetes (IDRS score ≥60 and without diabetes on the OGTT) were recruited.Results: A total of 1007 participants (47.2% women) were recruited over nine months. Pilot testing, personal contact and telephone reminders from community volunteers, and gender matching of staff were effective recruitment strategies. The major recruitment challenges were: (1) during home visits, one-third of potential participants could not be contacted, as they were away for work; and (2) men participated less frequently in the OGTT screening than women (75.2% vs. 84.2%). For non-participation, lack of time (42.0%) was most commonly cited followed by 'I am already feeling healthy' (30.0%), personal reasons (24.0%) and 'no benefit to me or my family' (4.0%). An average of 17 h were spent to recruit one participant with a cost of US$23. The initial stage of screening and recruitment demanded higher time and costs.Conclusions: This study provides valuable information for future researchers planning to implement community-based diabetes prevention trials in India or other LMICs.Trial registration: Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909.
AB - Background: Data on participant recruitment into diabetes prevention trials are limited in low- and middle-income countries (LMICs). We aimed to provide a detailed analysis of participant recruitment into a community-based diabetes prevention trial in India.Methods: The Kerala Diabetes Prevention Program was conducted in 60 polling areas (electoral divisions) of the Neyyatinkara taluk (subdistrict) in Trivandrum district, Kerala state. Individuals (age 30-60 years) were screened with the Indian Diabetes Risk Score (IDRS) at their homes followed by an oral glucose tolerance test (OGTT) at community-based clinics. Individuals at high-risk of developing diabetes (IDRS score ≥60 and without diabetes on the OGTT) were recruited.Results: A total of 1007 participants (47.2% women) were recruited over nine months. Pilot testing, personal contact and telephone reminders from community volunteers, and gender matching of staff were effective recruitment strategies. The major recruitment challenges were: (1) during home visits, one-third of potential participants could not be contacted, as they were away for work; and (2) men participated less frequently in the OGTT screening than women (75.2% vs. 84.2%). For non-participation, lack of time (42.0%) was most commonly cited followed by 'I am already feeling healthy' (30.0%), personal reasons (24.0%) and 'no benefit to me or my family' (4.0%). An average of 17 h were spent to recruit one participant with a cost of US$23. The initial stage of screening and recruitment demanded higher time and costs.Conclusions: This study provides valuable information for future researchers planning to implement community-based diabetes prevention trials in India or other LMICs.Trial registration: Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909.
U2 - 10.1016/j.conctc.2019.100382
DO - 10.1016/j.conctc.2019.100382
M3 - Article
C2 - 31193921
SN - 2451-8654
VL - 15
JO - Contemporary clinical trials communications
JF - Contemporary clinical trials communications
M1 - 100382
ER -
