ABSTRACT
BACKGROUND: Recruiting participants with cardiovascular disease into research during the COVID-19 pandemic was challenging, particularly those at risk of health disparities. OBJECTIVE: During the pandemic, 12 cohorts of older women with cardiovascular disease were recruited from cardiology clinics into a lifestyle intervention trial to prevent cognitive decline. Objectives were to (a) describe the results of modified recruitment/screening strategies to overcome pandemic-related challenges and (b) evaluate differences in age, race, and ethnicity between patients recruited/randomized, recruited/not randomized (entered recruitment but not randomized because of being ineligible or not interested), and not recruited (clinic patients who met preliminary criteria but did not enter recruitment). METHODS: This was a cross-sectional descriptive analysis. In-person study strategies proposed before the COVID-19 pandemic were modified before study onset (September 2020). Women 65 years or older with cardiovascular disease were recruited from cardiology clinics by clinicians, posted flyers, and letters mailed to patients randomly selected from electronic health record data extractions. Patients were classified as recruited/randomized, recruited/not randomized, and not recruited. RESULTS: Of 5719 patients potentially eligible, 1689 patients entered recruitment via referral (49.1%), posted flyers (0.5%), or mailed letters (50.3%), and 253 patients were successfully recruited/randomized. Recruited/randomized participants were, on average, 72.4 years old (range, 65-90 years old), non-Hispanic White (54.2%), non-Hispanic Black (38.3%), Hispanic/Latinx (1.6%), and other/not reported (5.1%). The recruited/randomized group was significantly younger with fewer patients of Hispanic/Latinx ethnicity compared with those not recruited. CONCLUSIONS: During the pandemic, all recruitment/screening goals were met using modified strategies. Differences in sociodemographic representation indicate a need for tailored strategies.
ABSTRACT
The global pandemic of coronavirus disease 2019 (COVID-19) affected many aspects of randomized controlled trials, including recruiting and screening participants. The purpose of this paper is to (a) describe adjustments to recruitment and screening due to COVID-19, (b) compare the proportional recruitment outcomes (not completed, ineligible, and eligible) at three screening stages (telephone, health assessment, and physical activity assessment) pre- and post-COVID-19 onset, and (c) compare baseline demographic characteristics pre- and post-COVID-19 onset in the Working Women Walking program. The design is a cross-sectional descriptive analysis of recruitment and screening data from a 52-week sequential multiple assignment randomized trial (SMART). Participants were women 18-70 years employed at a large urban medical center. Recruitment strategies shifted from in-person and electronic to electronic only post-COVID-19 onset. In-person eligibility screening for health and physical activity assessments continued post-COVID-19 onset with Centers for Disease Control and Prevention precautions. Of those who expressed interest in the study pre- and post-COVID-19 onset (n = 485 & n = 269 respectively), 40% (n = 194) met all eligibility criteria pre-COVID-19 onset, and 45.7% (n = 123) post-COVID-19 onset. Although there were differences in the proportions of participants who completed or were eligible for some of the screening stages, the final eligibility rates did not differ significantly pre-COVID-19 versus post-COVID-19 onset. Examination of differences in participant demographics between pre- and post-COVID-19 onset revealed a significant decrease in the percentage of Black women recruited into the study from pre- to post-COVID-19 onset. Studies recruiting participants into physical activity studies should explore the impact of historical factors on recruitment.