Overcoming Pandemic-Related Challenges in Recruitment and Screening: Strategies and Representation of Older Women With Cardiovascular Disease for a Multidomain Lifestyle Trial to Prevent Cognitive Decline.

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.

Challenges in Recruitment and Processing Hospice Patients for Research (SA302A)

Outcomes: 1. Upon completion of the presentation, participants will know what the barriers are to recruiting and processing hospice patients for research 2. Upon completion of the presentation, participants will know what strategies were used to increase the number of hospice patient referrals To assist hospice caregivers in pain reporting and administration of analgesics in home hospice settings, we are conducting a randomized clinical trial to test the use of an enhanced digital application (e-PainSupport). Operational challenges experienced by hospice agencies as a result of the COVID-19 pandemic, including decreases in nursing staff and increases in nursing workload, have led to challenges with recruiting hospice patients, caregivers, and nurses during this clinical trial. To address these challenges, several changes to our study design and recruitment strategies have been implemented. We have added additional data collection sites, contracted hospice staff members to facilitate referrals, initiated radio and on-hold messaging advertisements, and introduced electronic health record searches to identify patients. Since introducing these new strategies, we have seen an increase in referrals from 65 in the first 6 months to 93 in the second 6 months.

Effects of the COVID-19 pandemic on recruitment for the working women walking program.

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.

Modifications in response to the COVID-19 pandemic in a multimodal intervention trial to prevent cognitive impairment in older women with cardiovascular disease

Background Cognitive impairment disproportionately affects women compared to men, and cardiovascular disease (CVD) increases risk. Physical activity and cognitive training may have synergistic effects on cognition when delivered together. However, no multimodal intervention has targeted older women (≥65) with CVD or has utilized a scalable lifestyle approach. Our study seeks to evaluate the efficacy of MindMoves, a 24-week multimodal intervention, on cognition and serum biomarkers in 254 older women with CVD. However, effects of the COVID-19 pandemic complicated implementation of our original in-person trial protocol. The purpose of this paper is to describe protocol modifications made by our interdisciplinary team in response to COVID-19, Method We employ a 2x2 factorial randomized controlled trial design to determine independent and combined efficacies of Mind (cognitive training with BrainHQ) and Move (lifestyle physical activity with goal self-monitoring and nurse-led group meetings) interventions. Outcome measures of cognition and serum biomarkers (brain-derived neurotrophic factor, vascular endothelial growth factor, insulin-like growth factor 1) are collected at baseline, 24, 48, and 72 weeks. Nurse scientists oversee interventions, cardiologists refer women ≥65 years with CVD and no cognitive impairment from clinics, and a cognitive neurologist and neuropsychologist oversee outcome measures. Pandemic-related protocol changes were implemented to maximize study integrity and participant/staff safety. Targeted mailings were added to in-person recruitment strategies. Screening activities shifted to phone. In-person data collection was modified for phone/virtual settings, including accelerometer mailing (device measure of physical activity), neurocognitive tests validated for phone use, and home-based participant-administered dried blood spot collection for serum biomarkers. Women are now provided and trained to use iPad tablets to complete intervention activities virtually (e.g., Move group meetings). Result The anticipated number of participants (19) in the first cohort was recruited without disruption, in the original timeline. Participants completed all phone-based questionnaires and mailed devices were returned. Randomization occurred as planned. Intervention activities are ongoing, including phone-based orientations and ≥90% attendance at virtual meetings. Conclusion The modified trial protocol is being successfully implemented during the COVID-19 pandemic. Results will demonstrate efficacy of pivoting from in-person to virtual delivery of a lifestyle-focused multimodal intervention in at-risk older women with CVD.