PMID- 37104029
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230515
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 12
DP  - 2023 Apr 27
TI  - Blood Pressure and Self-management in Black Women With Hypertension: Protocol 
      Revisions to the Brain Relationships Among Information, Neuroprocessing, and 
      Self-Management Study Due to the COVID-19 Pandemic.
PG  - e43849
LID - 10.2196/43849 [doi]
LID - e43849
AB  - 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 A(1c) 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 A(1c) 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.
CI  - (c)Lenette M Jones, Kayla de Marco, Katharine Keener, Korrey E Monroe. Originally 
      published in JMIR Research Protocols (https://www.researchprotocols.org), 
      27.04.2023.
FAU - Jones, Lenette M
AU  - Jones LM
AUID- ORCID: 0000-0003-0994-5687
AD  - Health Behavior and Biological Sciences, School of Nursing, University of 
      Michigan, Ann Arbor, MI, United States.
FAU - de Marco, Kayla
AU  - de Marco K
AUID- ORCID: 0000-0001-6591-977X
AD  - School of Nursing, University of Michigan, Ann Arbor, MI, United States.
FAU - Keener, Katharine
AU  - Keener K
AUID- ORCID: 0000-0003-2219-4275
AD  - School of Nursing, University of Michigan, Ann Arbor, MI, United States.
FAU - Monroe, Korrey E
AU  - Monroe KE
AUID- ORCID: 0000-0001-5788-0086
AD  - School of Nursing, University of Michigan, Ann Arbor, MI, United States.
LA  - eng
PT  - Journal Article
DEP - 20230427
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC10176141
OTO - NOTNLM
OT  - BRAINS
OT  - Black
OT  - COVID-19 pandemic
OT  - Facebook
OT  - eHealth
OT  - hypertension
OT  - protocol
OT  - videoconferencing
OT  - web-based
OT  - women
COIS- Conflicts of Interest: None declared.
EDAT- 2023/04/27 12:42
MHDA- 2023/04/27 12:43
PMCR- 2023/04/27
CRDT- 2023/04/27 11:54
PHST- 2022/11/20 00:00 [received]
PHST- 2023/03/01 00:00 [accepted]
PHST- 2023/03/01 00:00 [revised]
PHST- 2023/04/27 12:43 [medline]
PHST- 2023/04/27 12:42 [pubmed]
PHST- 2023/04/27 11:54 [entrez]
PHST- 2023/04/27 00:00 [pmc-release]
AID - v12i1e43849 [pii]
AID - 10.2196/43849 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2023 Apr 27;12:e43849. doi: 10.2196/43849.