RESUMEN
Background: High blood pressure (hypertension) disproportionately affects African American/Black (Black) women. Previous research suggests that self-managing hypertension may be challenging, yet mobile applications (apps) can help to empower patients and increase medication adherence. We developed questions to test the usability of evaluating the WHISE (Wellness, Hypertension, Information Sharing, Self-Management, Education) mobile app for Black women with hypertension. Methods: Fifteen participants completed usability testing; five were potential app users (Black women with hypertension); each invited two of their peers to participate. Each testing session (n=5) included a brief overview of the app, time for participants to complete surveys and have an active discussion about the app (concurrent and retrospective think-aloud, concurrent and retrospective probing, per usability.gov), and observation of participants' body language during the session. Testing sessions were designed to familiarize participants with the app's features and examine their navigating ability. Results: The app received overwhelmingly positive feedback, with 80% of participants finding it to be a valuable tool in hypertension management. Participants praised the app's user-friendliness and educational value, with one stating, 'It is a good educational piece for helping people manage hypertension, at least to understand its basics.' Another participant highlighted the potential for community support, saying, 'Having a community, having some people to be accountable, to check in with and see how things are going, could encourage and motivate people to be more diligent about managing their hypertension.' Some participants also provided constructive feedback, suggesting font size adjustments (73%) and color scheme changes (60%) for certain screens. Conclusions: Based on the feedback we received, we were able to mitigate the participants' concerns about font size and color and create tutorial videos to guide future users in using the app. We completed these changes prior to deploying the app in our randomized clinical controlled trial.
RESUMEN
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. Due to the pandemic, we had to revise our protocol for the 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 7 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 participate in the BRAINS study to undergo a functional magnetic resonance imaging 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 a web-based, interactive approach. Participants received a study kit that included an Omron automatic home blood pressure monitor and a hemoglobin A1c 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 finger stick to collect a blood sample for hemoglobin A1c testing. We examined cognitive function using the TestMyBrain Digital Neuropsychology Toolkit, as we were unable to access the functional magnetic resonance imaging laboratory to assess brain activity. The 7 steps in revising our protocol were as follows: conceptualizing the move from in-person to remote study activities (step 1); contacting the funders (step 2); submitting changes for Institutional Review Board approval (step 3); preparing to implement the revised protocol (step 4); implementing the study changes (step 5); mitigating challenges (step 6); and evaluating protocol implementation (step 7). RESULTS: Approximately 1700 individuals responded to web-based advertisements about the BRAINS study. A total of 131 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 3-month period. CONCLUSIONS: In this report, we discuss 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 create similar protocols to reach and conduct research remotely with diverse populations, such as individuals who are unable to participate in studies in person. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43849.
