JMIR Publications

ABSTRACT

Background:

The COVID-19 pandemic and the halt to in-person research activities beginning in March 2020 brought new challenges to protocol development and implementation. It necessitated changes to our original protocol for our Brain Relationships Among Information, Neuroprocessing, and Self-Management (BRAINS) study, which was designed to examine health information behavior, brain activity, diabetes status, and self-management behavior among Black women with hypertension.

Objective:

This report outlines seven steps describing how our research team 1) revised the BRAINS study protocol, 2) implemented a remote method of data collection, and 3) mitigated the challenges we faced.

Methods:

Prior to March 2020, Black women with hypertension were invited to undergo a functional Magnetic Resonance Image (fMRI) scan, complete surveys, have their blood pressure measured, and have their blood drawn. After these measures were collected, participants would receive phone calls from a dietician to complete two 24-hour dietary recalls using the Nutrition Data System for Research. Our revised protocol relied on an online, interactive approach. Participants received a study kit with an Omron automatic blood pressure cuff and a hemoglobin A1C (HbA1c) kit from the DTIL laboratory. In a Zoom meeting with each participant, our team played an introductory video, administered surveys (via Qualtrics), and guided participants through measuring their blood pressure and performing a fingerstick to collect a blood sample for HbA1c testing. We examined cognitive function using the Test My Brain Digital Neuropsychology Toolkit, as we were unable to access the fMRI laboratory to assess brain activity. The seven steps in revising our protocol included: Step 1 - Conceptualize moving from in-person to remote study activities; Step 2 - Contact the funders; Step 3-Submit changes for Institutional Review Board (IRB) approval; Step 4 - Prepare to implement the revised protocol; Step 5 - Implement the study changes; Step 6 - Mitigate challenges; and Step 7 - Evaluate protocol implementation.

Results:

Approximately 1700 individuals responded to online advertisements about the BRAINS study. One hundred thirty-one individuals completed our eligibility screener. We conducted our first Zoom appointment in July 2020 and our last Zoom appointment in September 2020. Using our revised strategies, a total of 99 participants completed all study measures within a three-month period.

Conclusions:

This article concludes with a discussion of successes and challenges in revising our protocol and reaching our population of interest remotely, safely, and effectively. The information we have outlined can help researchers to create similar protocols to reach and conduct research remotely with diverse populations, such as Black women. Clinical Trial: n/a