Leveraging Telehealth to Overcome Research Implementation and Data Collection Challenges in the Era of COVID-19

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Project Summary In the era of the COVID-19 pandemic there has been an unprecedented scale of disruption in implementation of health research around the world. Health systems, health providers and patients alike have been negatively impacted by the lockdowns, restrictions to travel, the need for social distancing, the lack of personal protective equipment among others. Compliance to new requirements has resulted in protocol adjustments and unexpected expenses in the field research operations. The administrative supplemental funding request is motivated by our team’s commitment to complete data collection to achieve a sample size with adequate power for statistical significance. The parent study protocol required close in-person interactions between research staff and patients during the baseline enrollment and follow up visits. The baseline enrollment visit involves face-to-face screening for study eligibility, obtaining written informed consent, clinical assessment, a baseline questionnaire and training patients in the VDOT intervention arm to use of a smartphone app as part of the trial. The follow-up involves 3 in-person visits follow up visits at the clinics. To-date, the parent study timeline expires April 30th 2021, yet only 30.6% of the study participants have completed the study. The goal of the supplement is to modify study implementation protocols to increase use of telehealth to enhance efficiency, safety and completion of follow up visits. The goal of this project will be accomplished through the following specific aims.