IMPORTANCERacial and ethnic diversity among study participants is associated with improved generalizability of clinical trial results and may address inequities in evidence that informs public health strategies. Novel strategies are needed for equitable access and recruitment of diverse clinical trial populations. OBJECTIVE To investigate demographic and geographical location data for participants in 2 remote COVID-19 clinical trials with online recruitment and compare with those of a contemporaneous clinic-based COVID-19 study. DESIGN, SETTING, AND PARTICIPANTS This cohort study was conducted using data from 3 completed, prospective randomized clinical trials conducted at the same time: 2 remotely conducted studies (the Early Treatment Study and Hydroxychloroquine COVID-19 Postexposure Prophylaxis [PEP] Study) and 1 clinic-based study of convalescent plasma (the Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19 study). Data were collected from March to August 2020 with 1 to 28 days of participant follow-up. All studies had clinical sites in Seattle, Washington; the 2 remote trials also had collaborating sites in New

No abstract

Background The coronavirus disease 2019 (COVID-19) pandemic has challenged researchers performing clinical trials to develop innovative approaches to mitigate infectious risk while maintaining rigorous safety monitoring. Methods In this report we describe the implementation of a novel exclusively remote randomized clinical trial (ClinicalTrials.gov NCT04354428) of hydroxychloroquine and azithromycin for the treatment of the SARS-CoV-2–mediated COVID-19 disease which included cardiovascular safety monitoring. All study activities were conducted remotely. Self-collected vital signs (temperature, respiratory rate, heart rate, and oxygen saturation) and electrocardiographic (ECG) measurements were transmitted digitally to investigators while mid-nasal swabs for SARS-CoV-2 testing were shipped. ECG collection relied on a consumer device (KardiaMobile 6L, AliveCor Inc.) that recorded and transmitted six-lead ECGs via participants’ internet-enabled devices to a central core laboratory, which measured and reported QTc intervals that were then used to monitor safety. Results Two hundred and thirty-one participants uploaded 3245 ECGs. Mean daily adherence to the ECG protocol was 85.2% and was similar to the survey and mid-nasal swab elements of the study. Adherence rates did not differ by age or sex assigned at birth and were high across all reported race and ethnicities. QTc prolongation meeting criteria for an adverse event occurred in 28 (12.1%) participants, with 2 occurring in the placebo group, 19 in the hydroxychloroquine group, and 7 in the hydroxychloroquine + azithromycin group. Conclusions Our report demonstrates that digital health technologies can be leveraged to conduct rigorous, safe, and entirely remote clinical trials.

No abstract

Background Existing research has documented higher levels of cognitive impairment among marginalized populations, including among LGBT (lesbian, gay, bisexual, and transgender) older adults. Research has also found LGBT older adults living with cognitive impairment experience a unique and challenging context compared to their heterosexual and cisgender peers. However, there remains a paucity of research regarding culturally appropriate dementia interventions and services that are responsive to the needs, risks, and protective factors of such underserved populations. Method Aging with Pride: IDEA (Innovations in Dementia Empowerment and Action) is the first federally funded study to test an intervention designed to address the distinct needs of LGBT older adults with cognitive impairment and their caregivers. The study design compares a specialized LGBT enhanced program to a pre‐existing standard dementia program (RDAD), which provided the foundation for the project. This presentation will examine the ways in which the demographic profile and the recruitment and retention findings differ for this population compared to most existing dementia intervention research. Result Among the LGBT older adults living with cognitive impairment in this study, 74.8% identified as gay or lesbian and 7% as bisexual; 6.3% as transgender. Among caregivers, this was 69.9%, 15.4%, and 7%, respectively. People of color accounted for 16.8% of care recipients and 23.1% of caregivers. Care recipients were significantly more likely to initiate contact to enlist in the randomized controlled trial (RCT) compared to caregivers. One‐third of care recipients had a non‐partner/spouse caregiver supporting them in this dyadic intervention; 15.4% had a friend in the care partner role. The most common reason for study ineligibility was not having a care partner to participate and about 12% terminated from the program because of difficulty within the care partner/care recipient dyad. Conclusion The current study built a strong research‐community partnership necessary for the development and implementation of the intervention. The information gained in this study regarding recruitment, retention, and implementation is valuable for developing interventions that can be tailored to the distinct needs of communities that have traditionally been underserved in dementia research.