Development of a decentralized cohort for studying post-acute sequelae of COVID-19 in India in the Data4life Study

Abstract

Background Decentralized, digital health studies can provide real-world evidence of the lasting effects of COVID-19 on physical, socioeconomic, psychological, and social determinant factors of health in India. Existing research cohorts, however, are small and were not designed for longitudinal collection of comprehensive data from India’s diverse population. Data4Life is a nationwide, digitally enabled, health research initiative to examine the post-acute sequelae of COVID-19 across individuals, communities, and regions. Data4Life seeks to build an ethnically and geographically diverse population of at least 100,000 participants in India. Methods Here we discuss the feasibility of developing a completely decentralized COVID-19 cohort in India through qualitative analysis of data collection procedures, participant characteristics, participant perspectives on recruitment and reported study motivation. Results As of June 13th, 2022, more than 6,000 participants from 17 Indian states completed baseline surveys. Friend and family referral were identified as the most common recruitment method (64.8%) across all demographic groups. Helping family and friends was the primary reason reported for joining the study (61.5%). Conclusions Preliminary findings support the use of digital technology for rapid enrollment and data collection to develop large health research cohorts in India. This demonstrates the potential for expansion of digitally enabled health research in India. These findings also outline the value of person-to-person recruitment strategies when conducting digital health research in modern-day India. Qualitative analysis reveals opportunities to increase diversity and retention in real time. It also informs strategies for improving participant experiences in the current Data4Life initiative and future studies.

Barriers and facilitators for recruiting and retaining male participants into longitudinal health research: a systematic review

“…A total of 24 articles remained and the data was extracted and included in this review. The oldest of these studies was published from 1976 [ 36 ] and the most recent, 2023 [ 37 , 38 ]. All of the included studies were conducted in Western countries except Cheraghi et al, which was based in the Middle East [ 39 ] and Schilling et al, which was based in India [ 37 ]; two were located in United Kingdom [ 40 , 41 ], two in France [ 42 , 43 ], one in Finland [ 44 ], one in Sweden [ 45 ], one in The Netherlands [ 46 ], one study across combined European nations [ 29 ], one in Germany [ 47 ] ten in North America [ 36 , 48 – 56 ] and three in Australia [ 38 , 57 , 58 ] and are described in Table 1 .…”

“…All of the included studies were conducted in Western countries except Cheraghi et al, which was based in the Middle East [ 39 ] and Schilling et al, which was based in India [ 37 ]; two were located in United Kingdom [ 40 , 41 ], two in France [ 42 , 43 ], one in Finland [ 44 ], one in Sweden [ 45 ], one in The Netherlands [ 46 ], one study across combined European nations [ 29 ], one in Germany [ 47 ] ten in North America [ 36 , 48 – 56 ] and three in Australia [ 38 , 57 , 58 ] and are described in Table 1 . Participant characteristics varied with study focus including participants with specific health conditions, such as overweight [ 41 , 57 ], having an occupational injury [ 40 , 41 ], having visited a sexually transmitted infection clinic [ 46 ], or being treated for a psychological disorder [ 44 , 50 , 53 ], COVID related issues [ 37 , 54 ], or habits such as alcohol abuse and smoking [ 56 ]. Some studies recruited participants from specific subgroups, including veterans [ 36 ], workers of an electricity company [ 42 ] and people that had attended a spouse abuse abatement program [ 50 ].…”

“…Of the included studies, 20 had male and female participants [ 37 – 40 , 42 – 49 , 51 – 58 ], with a number of these studies having a predominantly male sample [ 42 , 52 , 53 , 58 ]. Four studies recruited only male participants [ 36 , 41 , 50 , 61 ] (Table 2 ).…”

“…Overall, all studies provided information on recruitment rates and 19 provided information on retention rates [ 36 , 38 – 41 , 43 – 47 , 49 – 52 , 55 – 58 , 61 ] (Table 2 ). A variety of methods for male participant recruitment included advertising [ 36 , 43 , 54 , 57 ], letters of invitation [ 39 – 43 , 47 , 52 , 56 – 58 , 61 ], selection of participants from larger cohorts [ 42 , 43 , 50 , 53 ], or recruitment from hospitals or registers [ 37 , 44 , 48 , 51 , 54 , 57 ] (Table 3 ). The most common method was sending letters of invitation, used in 11 out of the 24 studies, and yielded recruitment rates between 4.4% and 79.3% [ 47 , 52 ].…”

“…Another 1.6% were recruited through study referral at site ( n = 15/920), of which 53.2% identified as male ( n = 8/15) Reported above Schilling et al . 2023 [ 37 ] 99.2% of eligible individuals consented ( n = 6,375/6,426). 92.63% ( n = 5,905/6,375) of these individuals completed baseline surveys and of these participants, 74.02% identified as male ( n = 4,371/5,905) 1.4% attrition rate from completion of baseline survey to COVID-19 analysis ( n = 5,823/5,905).…”