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. 2019 May 21:15:100382.
doi: 10.1016/j.conctc.2019.100382. eCollection 2019 Sep.

Participant recruitment into a community-based diabetes prevention trial in India: Learnings from the Kerala Diabetes Prevention Program

Thirunavukkarasu Sathish  1 , Zahra Aziz  1 , Pilvikki Absetz  2 , Kavumpurathu Raman Thankappan  3 , Robyn Jennifer Tapp  4 , Sajitha Balachandran  3 , Suman Surendra Shetty  1 , Brian Oldenburg  1   5
Affiliations

Participant recruitment into a community-based diabetes prevention trial in India: Learnings from the Kerala Diabetes Prevention Program

Thirunavukkarasu Sathish et al. Contemp Clin Trials Commun. .

Abstract

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.

Keywords: Challenges; Costs; Diabetes; India; Recruitment; Staff time.

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Figures

Fig. 1
Fig. 1
K-DPP screening and recruitment flow chart.
Fig. 2
Fig. 2
K-DPP recruitment progress.
See this image and copyright information in PMC

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