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Original Paper

Exploring the Acceptability and Feasibility of Remote Blood
Pressure Measurements and Cognition Assessments Among
Participants Recruited From a Safety-Net Emergency Department(Reach Out Cognition): Nonrandomized Mobile Health Trial
Mackenzie Dinh1, MS; Chun Chieh Lin2, MBA, PhD; Candace Whitfield1, BS; Zahera Farhan1, MPH; William J
Meurer1, MS, MD; Sarah Bailey3, MA, PhD; Lesli E Skolarus4, MS, MD
1

Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, United States

2

Division of Health Services Research, Department of Neurology, The Ohio State University, Columbus, OH, United States

3

Bridges into the Future, Flint, MI, United States

4

Davee Department of Neurology, Northwestern University, Chicago, IL, United States

Corresponding Author:
Lesli E Skolarus, MS, MD
Davee Department of Neurology
Northwestern University
625 N Michigan Ave
Chicago, IL, 60611
United States
Phone: 1 312 503 0399
Email: lesli.skolarus@northwestern.edu

Abstract
Background: Hypertension is a prevalent cardiovascular risk factor disproportionately affecting Black Americans, who also
experience a higher incidence of Alzheimer disease and Alzheimer disease–related dementias. Monitoring blood pressure (BP)and cognition may be important strategies in reducing these disparities.
Objective: The objective of the Reach Out Cognition study was to explore the feasibility and acceptability of remote cognitive
and BP assessments in a predominantly Black, low-income population.
Methods: Reach Out was a randomized, controlled, mobile health–based clinical trial to reduce BP among patients withhypertension at an emergency department in a safety-net hospital (ie, a US hospital in which 25% of the patients are Medicaid
recipients). Upon conclusion of Reach Out, participants were given the option of continuing into an extension phase, Reach Out
Cognition, that included Bluetooth-enabled BP monitoring and digital cognitive assessments for 6 months. Digital cognitive
assessments were text message–linked online surveys of the Self-Administered Gerocognitive Exam and Quality of Life in
Neurological Disorders scale. BP assessments were measured with Bluetooth-enabled BP cuffs paired with an app and the data
were manually sent to the research team. Outcomes were feasibility (ie, enrollment and 3- and 6-month completion of digital
cognitive and BP assessments) and acceptability of assessments using a 4-item validated survey, ranging from 1 (not acceptable)
to 5 (completely acceptable).
Results: Of the 211 Reach Out participants, 107 (50.7%) consented and 71 (33.6%) completed enrollment in Reach Out
Cognition. Participants had a mean age of 49.9 years; 70.4% were female and 57.8% identified as Black. Among the 71 participants,
51 (72%) completed cognitive assessments at 3 months and 34 (48%) completed these assessments at 6 months. BP assessments
were completed by 37 (52%) and 20 (28%) of the 71 participants at 3 and 6 months, respectively. Participants were neutral on
the acceptability of the digital cognitive assessments (mean 3.7) and Bluetooth self-measured BP (SMBP) monitoring (mean 3.9).
Participants noted challenges syncing the BP cuff to the app, internet connection, and transmitting the data to the research team.
Conclusions: Enrollment and assessment completion were low, while acceptability was moderate. Technological advances will
eliminate some of the Bluetooth SMBP barriers and offer new strategies for cognitive assessments. Subsequent studies could
benefit from offering more comprehensive support to overcome Bluetooth-related hurdles, such as personalized training materials,
video conferencing, or in-person research team support. Alternatively, strategies that do not require pairing with an app andhttps://formative.jmir.org/2024/1/e54010

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Dinh et alpassive transmission of data could be considered. Overall, further research is warranted to optimize participant engagement andovercome technological challenges.
Trial Registration: ClinicalTrials.gov NCT03422718; https://clinicaltrials.gov/study/NCT03422718(JMIR Form Res 2024;8:e54010) doi: 10.2196/54010
KEYWORDS
hypertension; cognition; mobile health; Bluetooth; remote; monitoring; monitor; low income; mHealth; hypertensive; cardiology;
cardiovascular; feasibility; acceptability; satisfaction; RCT; randomized controlled trial; assessment; blood pressure; neurological;
mobile health

Introduction
In the United States, Black people experience the highest
incidence of Alzheimer disease and Alzheimer disease–relateddementias, with a 2-fold greater incidence compared to that of
the non-Hispanic White population [1-5]. Numerous large
epidemiological studies have demonstrated an association
between elevated blood pressure (BP) and the development ofmild cognitive impairment and dementia [6,7]. Considering thedisproportionate burden of hypertension among Black people
and individuals with low income, interventions that specificallyprioritize these high-risk groups are needed.
Mobile health (mHealth) is defined by the World HealthOrganization as a medical or public health practice that is
supported by mobile devices such as smartphones or tablets [8].
Black Americans have higher smartphone usage than their White
counterparts [9]. Thus, mHealth may offer an approach toovercome racial disparities by providing a new way to promotehealth and complement health care [10]. Within mHealth, there
is growing interest in mHealth cognitive assessments, withongoing studies aiming to develop cognitive self-monitoring
apps and expand their implementation in clinical trials [11].
Bluetooth-enabled BP cuffs offer advantages such as automatictransfer of readings to smartphone apps, graphical displays, andgamification to increase engagement. While small-scale studies
have shown promise, the effectiveness of Bluetooth-enabled
BP cuffs in larger, more diverse populations still needs to betested [12].
In this context, we conducted Reach Out Cognition, a pilot
nonrandomized trial of Bluetooth-enabled BP monitoring anddigital cognitive assessments in patients with hypertension who
were recruited from a safety-net emergency department (ED),defined as hospitals in the United States where over 25% of
patients are Medicaid recipients [13], and elected to continue
in an extension study. Specifically, we sought to evaluate thefeasibility and acceptability of Bluetooth-enabled BP monitoringand digital cognitive assessments to inform the design of future
trials using these measures as part of the intervention oroutcomes.

Methods
Study Design
Reach Out Cognition was an extension of the Reach Out trial.
Briefly, the Reach Out trial was a randomized, controlled, 2×2×2
factorial-design mHealth clinical trial to reduce BP among
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safety-net ED patients with hypertension who were seeking carefor conditions with a high likelihood of discharge from the ED(ClinicalTrials.gov identifier NCT03422718) [14]. Specifically,
patients were eligible if (1) they had at least one documented
systolic BP reading ≥160 mm Hg or diastolic BP reading ≥100
mm Hg; (2) after achieving criterion 1, at least one repeat BP
measurement remained ≥140 mm Hg (systolic) or ≥90 mm Hg(diastolic); (3) they were likely to be discharged from the ED;
and (4) they possessed a cell phone with text messaging
capability. We excluded patients who were critically ill,otherwise
unableto
giveinformed
consent,
non-English–speaking, incarcerated, pregnant, had a preexisting
condition that made 1-year follow-up unlikely, currently used
3 or more antihypertensive agents (suggesting resistant
hypertension), or had dementia/cognitive impairment.
Enrollment occurred from March 2019 to March 2020.
Participants were randomized to the following groups: (1)prompted self-measured BP (SMBP) monitoring, (2) tailored
healthy behavior text messaging, and (3) facilitated primarycare provider scheduling and transportation. Overall, systolic
BP declined after 6 months (median mean difference −9.2 mm
Hg, 95% CI −12.2 to −6.3) and 12 months (−6.6 mm Hg, 95%
CI −9.3 to −3.8), without a difference across the 8 treatment
arms [15]. There was no difference in systolic BP among the 3
mHealth components. After completion of Reach Out,participants were given the opportunity to continue in Reach
Out Cognition, where they would continue to receive daily
healthy behavior text messages and weekly prompted BP
self-monitoring. Additional study details have been publishedelsewhere [16].

Reach Out Cognition Study Population
The study was conducted from September 2020 to February
2022. Adults were eligible if they were no more than 6 months
from completion of their 12-month Reach Out outcomes. Reach
Out Cognition was designed with the goal of inclusivity andgeneralizability, thus allowing for inclusion of all cell phones
with the capability to send picture text messages. We excluded
participants with baseline mild cognitive impairment according
to a score <8 on the telephone-Montreal Cognitive Assessment(T-MoCA-Short) [17].

Enrollment Procedures
Eligible Reach Out participants were contacted by the study
team and invited to participate in Reach Out Cognition. The
study design is described in Figure 1. Those interested wereconsented and then mailed a wireless, Bluetooth-enabled
OMRON 7 series upper-arm BP monitor (BP7350) or an
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JMIR FORMATIVE RESEARCHOMRON 7 series wrist BP monitor (BP6350) for those needinga larger cuff. Participants were also mailed written instructions
for taking their BP and using the Bluetooth BP monitor, alongwith instructions for completing cognitive outcomes based on
their phone’s capability, an individualized MoCA feedback
form, and a checklist of enrollment elements. Due to COVID-19,
all aspects of training were done remotely through phone, video,
written materials, or online trainings [18]. Participants withsmartphone capability were assisted in downloading the
OMRON app associated with the Bluetooth-compatible BP
monitor. Participants received optional assistance from the study
team for training on their specific OMRON cuff, OMRON app,and web-based surveys.
During enrollment, participants were texted a link to an online
Qualtrics survey that contained baseline cognitive assessments,
including a modified Self-Administered Gerocognitive Exam
(SAGE) and Quality of Life in Neurological Disorders(Neuro-QoL)–Cognition scale [19,20]. Participants who opted
not to take the cognitive assessments through Qualtrics were

Dinh et al
sent paper copies. Each week, participants were texted apersonalized message with instructions specifying what
remained incomplete (ie, BP, cognitive assessment) for
enrollment. To facilitate enrollment, multiple steps were
undertaken. First, participants were called and texted once
weekly for 1 month for assistance (maximum of 4 follow-up
texts and 4 follow-up calls). Phone or video calls with a study
coordinator, dependent on the participant’s preference, were
offered to help go through the Bluetooth connection step bystep and to address any other barriers. Second, text messages
included a link to the Reach Out website [18] to offer visual
examples and training for completing enrollment elements.
Third, each week, participants were texted a personalized
message with instructions. Fourth, participants were also mailed
phone-specific instructions, which included Bluetoothtroubleshooting advice. If participants did not complete BP andcognitive assessments and had no contact with the study teamfor 1 month post enrollment, they were withdrawn from thestudy.

Figure 1. Study flow and outcomes. BP: blood pressure; Neuro-QoL: Quality of Life in Neurological Disorders; SAGE: Self-Administered Gerocognitive
Exam; T-MoCA: telephone-Montreal Cognitive Assessment.

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mHealth Assessments
Data Collection
Outcome assessments were specific to whether the participant
had a smartphone or feature phone (ie, a phone without thecapability of downloading apps). Participants with smartphones
were asked to email/text their BP data downloaded from theirOMRON app to the study team. There was no connection
between the OMRON app and the study team. Participants withfeature phones were asked to send a photograph of their arm
with the BP cuff on and 3 self-reported BP readings. The
photograph was used to ensure the BP cuff was being worn
appropriately. Cognitive assessments were completed throughtext message–linked online surveys administered throughQualtrics. Outcome assessments were conducted at 3 and 6
months (±6 weeks) to allow participants the opportunity tocomplete the assessments. BP assessment completion was
defined as receipt of at least 3 BP measurements at 3 and 6
months. Cognitive assessment completion was defined ascompletion of the online assessment. Participants were contacted
at least five times, with three text messages and two calls
throughout the daytime, evening, and weekend hours toencourage assessment completion. If the participant expressed
difficulty with self-measured digital cognitive assessments or
BP measurements, they were contacted by the study team toprovide assistance.

Outcomes
Acceptability and feasibility are key drivers for establishingclinical trial readiness and attaining desired clinical outcomes[21-24]. Feasibility was defined as the extent to which digital
cognitive and BP assessments were completed [22]. Reach Out
Cognition feasibility was defined as the proportion of eligible
Reach Out participants who enrolled in Reach Out Cognition
and the proportion of participants who completed the digital
cognitive and BP assessments. Acceptability and satisfaction
were measured with a survey texted to all participants.
Acceptability of SMBP monitoring with the OMRON app anddigital cognitive assessments was measured using a validated
4-item scale [22]. Questions related to the overall satisfaction
with Reach Out Cognition and training, SMBP Bluetooth
monitoring using an app, and self-administered and digital
cognitive assessments. In addition, participants provided
feedback on interactions with the study team, technology
barriers, and overall experiences through Reach Out Cognition.

Exploratory Outcomes
Neuro-QoL and modified SAGE scores were compared atbaseline, 3 months, and 6 months. Neuro-QoL–Cognitive
short-form scores ranged from 1 to 40, with 40 indicating highcognitive function [20]. Modified SAGE scores ranged from 0

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to 22, with a score of 17 and above considered normal cognition[19].

Ethical Considerations
This study was approved by the University of Michigan
Institutional Review Board (HUM00138470) and ED site
Institutional Review Board (1199877). All participants provided
informed consent at the time of enrollment. The original
informed consent allowed primary data collection and fordeidentified use in additional analyses and research studies.
Participants of Reach Out Cognition were given an automatedBP cuff at enrollment, US $20 after completion of the 3-monthfollow-up visit, and US $30 after completion of the 6-monthfollow-up visit.

Statistical Analysis
Descriptive statistics were used to describe the study population
and assess feasibility and acceptability. The self-reported
measures were also assessed with descriptive statistics ascontinuous measures and dichotomized into agree (agree andcompletely agree vs neither agree nor disagree, disagree, andcompletely disagree). Cognitive measures were compared ascontinuous measures. Changes in these scores over the courseof the study were assessed by comparing the mean scores atbaseline, 3 months, and 6 months. The mean values of patientcharacteristics were compared with Student t tests. Estimatedsystolic BP was compared over time between groups using SAS
Proc Mixed Procedures with the LSMEANS function to comparemeans with the Tukey honestly significant difference test.

Results
Participant Characteristics
A total of 211 participants completed Reach Out and wereapproached for Reach Out Cognition. Of those, 107 (50.7%)
consented to Reach Out Cognition and 71 (33.6%) completed
enrollment and were participants in Reach Out Cognition (Figure2). The baseline characteristics of participants are shown in
Table 1. Participants had a mean age of 49.9 (SD 11.3) years,
70.4% were female, and 57.8% identified as Black. Among the
71 participants, 27 (38%) reported having completed some highschool, high school graduation, or trade school, while a larger
proportion (62%) had achieved some college education or
higher. Most participants reported having a primary care
physician (94.4%), and 9.9% were uninsured. Overall, 83.1%of the participants had a previous diagnosis of hypertension and66.2% were taking BP medications. Lack of transportation wascited as a barrier to health care access by 21.1% of theparticipants. The mean T-MoCA-Short total score was 9.62 (SD
1.5).

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Figure 2. CONSORT (Consolidated Standards of Reporting Trials) diagram. BP: blood pressure.

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Table 1. Baseline participant characteristics (N=71).
Characteristics

Participants, n (%)

Female sex

50 (70.4)

Hispanic ethnicity

2 (2.8)

Black race

41 (57.8)

Education
Some HSa, HS graduate, or trade school

27 (38.0)

Some college or higher

44 (62.0)

Married/living with someone

21 (29.6)

Not employed37 (52.1)

Currently have a PCPb

67 (94.4)

Uninsured

7 (9.9)Previous diagnosis of hypertension

59 (83.1)

Comorbidities
Diabetes

22 (31.0)

Heart attack

6 (8.5)CHFc

7 (9.9)Kidney disease

5 (7.0)High cholesterol

27 (38.0)

Cancer5 (7.0)Stroke/TIAd

11 (15.5)

Sleep apnea

28 (39.4)

Dementia

1 (1.4)Lung disease

22 (31.0)

Prior medication for hypertension within the last 6 months

47 (66.2)

Lack of transportation

15 (21.1)

Downloaded OMRON app

71 (100.0)

Phone model
Android

31 (43.7)

iPhone32 (45.1)

Google2 (2.8)Other

6 (8.5)Phone use
Text

71 (100.0)

Picture messages

63 (88.7)

Email

59 (83.1)

Health/physical activity apps

31 (43.7)

Social media apps

60 (84.5)

Maps

57 (80.3)

Other apps

17 (23.9)

Access to the internet

69 (97.2)

Phone

52 (73.2)

Personal computer

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CharacteristicsaParticipants, n (%)

Personal tablet/iPad

5 (7.0)Completion of T-MoCA-Shorte

69 (97.2)

HS: high school.

b

PCP: primary care physician.

c

CHF: chronic heart failure.

d

TIA: transient ischemic attack.

e

Telephone-Montreal Cognitive Assessment short form.

Technological Capability
Only 2.8% of participants had a nonsmartphone (feature phone).
Most participants had an Android or iPhone smartphone.
Participants used their phones for texting, picture messages,
and email. Additionally, 43.7% of participants used health orphysical activity apps on their phones, while social media apps
were used by 84.5% of the participants (Table 1). Among theparticipants who reported health and physical activity app use,these apps were primarily reported in the use of fitness tracking,provider connection, and general health tracking (see Table S1
in Multimedia Appendix 1). Other apps were generally forentertainment, communication, or personalized use. Regarding
internet access, 97.2% of participants reported having internet
access. Among those with internet access, the majority usedtheir phones to access the internet, followed by a personal
computer, and a smaller proportion used a personal tablet/iPad(Table 1).

Outcome Feasibility and Acceptability
Among the 71 participants, the digital cognitive assessments
were completed by 51 participants (72%) at 3 months and by
34 participants (48%) at 6 months. At least one cognitive
assessment was completed by 56 (79%) participants between
the 3- and 6-month outcomes. The BP assessments (either
through BP data downloaded or screenshot from their OMRON
app, or a picture with self-reported BPs) were completed by 37
participants (52%) at 3 months and by 17 participants (28%) at
6 months. Among the 17 participants who completed 6-monthoutcomes, 71% (n=12) self-reported using the OMRON app,with 19% of these participants reporting that they manuallyentered their BPs into the app. Participants noted challenges
syncing the BP cuff to the app, internet connection, andtransmitting the data to the research team (eg, the research team
did not have access to OMRON data). One participant noted,“just easier to look at the [BP] machine.”
Participants’ overall satisfaction with the study was assessed at
6 months. Among the 34 respondents, 79% (n=27) indicatedbeing satisfied or very satisfied with the study. Participants were
neutral regarding the acceptability of cognitive assessments andBluetooth SMBP monitoring. The median scores of most items
were in the neither agree nor disagree (3) to slightly agree (4)range (see Table S2 in Multimedia Appendix 1).

Exploratory OutcomesAt baseline, the mean Neuro-QoL score was 31.5 (SD 6.5) andthe mean modified SAGE score was 15.6 (SD 4.3). The
Neuro-QoL scores were stable at 3 months (mean 31.5, SD 5.8)
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were stable from baseline after 3 months (mean 17.4, SD 4.7)
and 6 months (mean 16.5, SD 3.0).

Discussion
Reach Out Cognition evaluated the feasibility and acceptabilityof Bluetooth SMBP monitoring and digital cognitive
assessments in a diverse population of adults with hypertension
recruited from a safety-net ED who elected to enroll in an
extended follow-up study. Overall, enrollment and outcome
completion were low, whereas acceptability was moderate,suggesting that additional strategies are needed to encourage
engagement of this population with Bluetooth SMBP monitoringand digital cognitive assessments.
The feasibility of remote assessments varied between cognitive
and BP measurements. We found that more participants
completed cognitive assessments than BP assessments. The
cognitive assessments were completed via web-based surveys
accessed from a text message link. While this is a preliminary
strategy of assessment, as cognitive assessments are moving toapps, this may be a feasible approach that could complementapps.
In addition, the BP assessments required more steps than the
cognitive assessments. This included pairing theBluetooth-enabled BP cuff with the app and sending data fromthe app to the study team. These were noted as challenges by
the participants. Some participants chose to manually enter BP
readings into the app rather than through Bluetooth transmission.
This may imply that the participants engaged in a way that aligns
with their current routine and technological familiarity.
Transmitting BP data from the app to the research or clinicalteam is now more readily available than when this pilot study
was conducted [25]. Thus, technological advances will eliminate
at least one of these barriers. Subsequent studies could benefit
from offering more comprehensive support to overcome
Bluetooth-related hurdles, such as personalized training
materials, video conferencing, or in-person research teamsupport. Alternatively, strategies that do not require pairing with
an app and passive transmission of data could be considered.
This study has some limitations. First, Reach Out Cognition
enrolled a selected population, given that it was an extensionof a prior trial that used text messaging for BP monitoring for
12 months. This limits the generalizability of our findings.
Because participants had already engaged in BP monitoring for
1 year through a different technique, feasibility may differ
among people initiating BP measurements. Second, although
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participants used a BP cuff that synced to a mobile app, theresearchers did not have direct access to the data within themobile app. Instead, participants had to send their BP
measurements to the research team via text message or othermethods, creating an extra hurdle for participants in the study.
Third, we did not perform a qualitative analysis after the study.
Thus, little is known about the participants’ motivation toparticipate in the study. Finally, we cannot exclude thepossibility that participants may have completed the BP
measurements but did not transfer the data to the research teamDinh et alor that someone other than the participant completed the BP or
cognitive assessments. However, this was advised against at
the enrollment visit.
Overall, enrollment and digital cognitive and SMBP monitoring
completion were low, while acceptability was moderate. As
future interventions aim to harness the potential of mHealth forcognition, a mixed remote and in-person approach that allows
personalization for participants based on their needs may be
key for maximizing the feasibility and acceptability of thesetools.

Acknowledgments
This study was funded by the National Institutes of Health, National Institutes of Minority Health and Disparities (R01 MD011516).

Data Availability
The data sets generated during and/or analyzed during this study are available from the corresponding author on reasonable
request.

Conflicts of Interest
None declared.

Multimedia Appendix 1
Participant app use (Table S1) and mobile health (mHealth) acceptability measures at 6-month follow-up (Table S2).
[DOCX File , 18 KB-Multimedia Appendix 1]

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Abbreviations
BP: blood pressure
ED: emergency department
mHealth: mobile health
Neuro-QoL: Quality of Life in Neurological Disorders
SAGE: Self-Administered Gerocognitive Exam
SMBP: self-measured blood pressure
T-MoCA-Short: telephone Montreal Cognitive Assessment short form

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Dinh et al

Edited by A Mavragani; submitted 31.10.23; peer-reviewed by P Zhang, M Wilkes; comments to author 04.03.24; revised version
received 23.03.24; accepted 08.04.24; published 28.05.24
Please cite as:
Dinh M, Lin CC, Whitfield C, Farhan Z, Meurer WJ, Bailey S, Skolarus LE
Exploring the Acceptability and Feasibility of Remote Blood Pressure Measurements and Cognition Assessments Among Participants
Recruited From a Safety-Net Emergency Department (Reach Out Cognition): Nonrandomized Mobile Health Trial
JMIR Form Res 2024;8:e54010
URL: https://formative.jmir.org/2024/1/e54010
doi: 10.2196/54010
PMID: 38805251©Mackenzie Dinh, Chun Chieh Lin, Candace Whitfield, Zahera Farhan, William J Meurer, Sarah Bailey, Lesli E Skolarus.
Originally published in JMIR Formative Research (https://formative.jmir.org), 28.05.2024. This is an open-access article distributed
under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits
unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Formative
Research, is properly cited. The complete bibliographic information, a link to the original publication on https://formative.jmir.org,
as well as this copyright and license information must be included.

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