Utilizing a Mobile Health (mHealth) Application to Improve Hypertension Monitoring and Self-management in an Underserved Community: A Pilot Study
Phase: NA
Conditions: Hypertension
Sponsor: Rutgers, The State University of New Jersey

 
 
 
 
Utilizing a mobile health (mHealth) application to improve hypertension 
monitoring and self-management in an underserved community: A pilot 
study 
Research Protocol 
NCT02632838 
February 8, 2018 
 
 
Peijia Zha Ph.D. 
 
Division of Nursing Science 
School of Nursing 
Rutgers, the State University of New Jersey 
 
 

 
 
Abstract 
Monitoring and self-management are important components of effective chronic disease 
care and improved patient outcomes. With the rapid development of integration of mobile 
health technology (mHealth) into health care delivery services, mHealth intervention 
provides a great opportunity to improve the efficiency of chronic disease management. 
However, little is known about whether mHealth interventions can effectively impact the 
health and health care outcomes in underserved populations. This pilot study will assess 
the preliminary effectiveness of a mobile-based health intervention in an urban 
underserved community with a high incidence of hypertension. It is hypothesized that 
patients with hypertension will experience improved outcomes due to the use of a mHealth 
application compared with patients who are not using the application. The findings from 
this study will advance our understanding of the utility of mHealth interventions among 
underserved populations and generate evidence to support this new health care delivery 
approach in underserved urban communities.    
 
Key words:  mHealth, hypertension, monitoring, self-management, underserved 
community 
 
 
 
 
 
 
 
 
 
 
 
 

 
Specific Aims 
This study will examine the effectiveness of a mHealth application to enhance hypertension 
monitoring and self‐management at an urban nurse‐managed community health center. 
The specific aims are to determine 1) whether hypertensive patients who are randomized 
to receive either the standard care plus the mHealth intervention or standard care will 
show differences in blood pressure (BP) control, 2) whether hypertensive patients who 
receive the standard care plus the mHealth intervention will show differences in patient‐
centered outcomes as compared to those receiving existing standard care only. 
Accordingly, the follow hypotheses will be evaluated:  
 
1. Hypertension patients using the mHealth application exhibit a greater decrease in 
blood pressure and better maintenance over a 6-month period compared to those 
who receive standard care. 
2. Hypertension patients using the mHealth application will exhibit more effective self-
management as compared to those who receive standard care.  
 
Patients receiving the intervention are expected to show greater BP decrease over 6 
months, greater maintenance of BP at 6 months, reduced hospital utilization, greater BP 
monitoring adherence, and are expected to improve health behaviors associated with 
better patient‐centered outcomes such as better health-related quality of life, greater self‐
efficacy and optimism about BP control, as compared to those receiving standard care only.   
 
Background and Significance 
Hypertension is the leading risk factor for cardiovascular disease and stroke, impacting 
more than 348,000 Americans in 2009 (CDC, 2012) and causing nearly 1000 deaths each 
day (Go et al. 2013). Approximately 31% (75 million) of American adults have high blood 
pressure, but only about half of these individuals have their condition under effective 
control (CDC, 2012). In addition, significant ethnic/racial and socioeconomic disparities 
persist in hypertension patients. The prevalence of hypertension in African Americans is 
among the highest in the U.S.; African Americans also have the highest rates of uncontrolled 
essential hypertension in this country. It has also been reported that African-Americans 
from lower socioeconomic classes are more likely to develop hypertension than other 
groups (Cooper, et al. 2000). The New Jersey Department of Health and Senior Service 
(2010) estimated that 29% (53,286) of the Newark adult population has high blood 
pressure. Unlike acute diseases that may be amenable to short-term interventions, 
hypertension requires long-term monitoring, self-management, behavior changes, and 
adherence to a medication regimen. The ability to help high-risk populations to constantly 
monitor, self-manage, control, and improve their condition plays a crucial role in 
successfully managing and preventing this particular chronic disease. Mobile Health 
technology (mHealth) has the potential to contribute significantly to hypertension 
management by enhancing monitoring and self-management among hypertension patients.  
 

 
mHealth is defined by the World Health Organization (WHO) as “medical and public health 
practices supported by mobile devices, such as mobile phones, patient monitoring devices, 
personal digital assistants (PDA), and other wireless devices” (WHO, 2011, p.6). Naturally, 
people use mobile devices to communicate, but technologies like this have powerful 
unintended outcomes (Morten, 1936). In the case of mobile devices, health monitoring 
practices can be recorded in real-time and then self-reported. Depending on when, where, 
why and how people use their mobile devices, self-reported, real-time health data can 
become a valuable unintended outcome of mobile device. Through this technology, 
individuals within geographically-specified target groups may voluntarily reveal 
information that is otherwise incredibly challenging to gather. For example, in a 2012 
Harvard study, cell phone data from 15 million cell phone users was gathered and used to 
identify and predict new patterns of malaria spread in Kenya. With the mHealth platform, 
patients can provide close to real-time feedback to their health providers. Based on such 
self-reported data, health providers could proactively predict patterns of the disease, and 
provide improved and timely educational programs to the targeted populations, thereby 
promoting more efficacious prevention and treatment strategies. Other research evidence 
also suggests that mHealth may be beneficial in weight loss treatment (Duncan et al, 2011; 
Spring et al. 2013), physical activity involvement (Hurling et al, 2007; Consolve et al, 2006), 
asthma control (Anhoj et al, 2004; Britto et al, 2012; Massoudi & Rothemich 2012) and 
diabetes management (Faridi et al, 2008; Vahatalo et al, 2004).  
 
Furthermore, Smith (2014) reports that more African Americans in this country use mobile 
phones than do Caucasians: 92% of African Americans own a cell phone, of which 56% own 
a smartphone. Additionally, text message use is common among people of varying health 
insurance statuses (PricewaterhouseCooper’s Health Research Institute, 2010). Together, 
these facts provide enough evidence to suggest that the mHealth platform may be able to 
penetrate the urban underserved community in which this study will be conducted. 
 
Existing Gaps between mHealth Applications and Underserved Populations 
Contextual gap: underuse of mHealth in underserved populations 
According to the NIH’s Seventh Report of the Joint National Committee on Prevention, 
Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7, 2004), life style 
modification and monitoring for blood pressure are among the necessary steps in 
hypertension therapy. At that time, electronically based support systems, such as 
computer‐based and PDA based technologies, were believed to be potential tools for 
hypertension treatment. The prevalence of mHealth in the past decade has realized some of 
this potential. Even though mHealth has been promoted by many for its utility in increasing 
wellness and changing life styles, the study of mHealth in clinical contexts targeting 
underserved populations has not been widely reported. To begin addressing this gap, the 
Robert Wood Johnson Foundation funded a $500,000 project in November of 2013 to 
educate entrepreneurs in bridging technical aspects of this gap. The proposed study is an 
attempt to bridge the gap in a clinical setting. 
 
Measurement gap: AMBP vs. self-measurement in hypertension treatment 

 
The JNC 7 specifically pointed out that two types of measurement, the Ambulatory Blood 
Pressure (AMBP), and self‐measurement, are important components for accurately 
measuring blood pressure. The characteristics of mHealth provide meaningful clinical 
measurement to address both a 24‐hour automatic measurement for AMBP and an easy 
access measurement by patients. The effectiveness of mHealth to fulfill these 
measurements is yet to be determined. 
 
Behavioral gap: mHealth and patients’ motivation in hypertension treatment 
Hypertension treatment is effective only when the patient is motivated (JCN7, 2004). A 
motived patient is willing to monitor his or her blood pressure, change his or her life style, 
and take necessary medications. How the use of mHealth motivates patients’ active 
participation remains unknown and needs to be explored. The provision of accessible 
feedback to patients coupled with support for behavioral change should, in theory, both 
motivate and support improved patient outcomes. 
 
Possible outcomes and implications for future research 
The integration of mobile technology and self-management of chronic diseases such as 
hypertension and diabetes presents the perfect opportunity for innovations in health care 
delivery.  However, it has proved challenging to integrate underserved populations into 
emerging healthcare strategies. This study will demonstrate that the mHealth intervention 
can provide a fast, reliable and inexpensive communication mechanism between health 
care providers and their underserved patients, which will help to integrate them into 
emerging innovations in health care delivery and reduce health and health care disparities. 
Specifically, this mHealth application study will not only make real-time patient monitoring 
feasible in underserved communities, but it can also help optimize the use of limited 
medical resources in these settings, adding to the promise of the nurse-managed 
community healthcare model by allowing nurses to proactively identify patients with 
worsening disease conditions in order to offer timely medical intervention. The results of 
this study will provide the initial data required to apply for future research funds from the 
National Institutes of Health (NIH), which has announced funding opportunities in 
developing and using mobile technologies to improve the health of underserved 
populations.  
 
Research Design and Methods 
Study Design 
This study will have two phases. In Phase 1, a pilot version of a randomized controlled trial 
(RCT) will be utilized to examine BP decline and BP maintenance with 30 participants 
assigned either to standard care and treatment (a control group) or to the standard care 
plus mHealth (the intervention group). In Phase 2, improved quality of life, patient self‐
efficacy, greater treatment adherence, reduced hospital utilization.   
 
 

 
Setting and Sample 
 
The proposed study will take place at the Jordan and Harris Community Health Center 
(J&HCHC) in Newark, NJ. The J&HCHC is a nurse-managed, community-directed health 
center providing health services for a vulnerable, underserved population in the city of 
Newark. This center is utilized by the residents of three public housing developments in the 
East Ward of Newark.  The great majority of these residents are low-income African 
Americans.   
 
The proposed pilot study sample of 30 patients (15 in the standard care group and 15 in 
the standard care plus mHealth intervention group) is approximately 10% of the 
approximate sample size we hope to incorporate into future mHealth studies (TCD 
Guidelines, 2010).   
 
Eligible study participants will be defined as 1)18-64 year-old residents of one of the three 
housing developments, and 2) subjects who have been documented with uncontrolled 
ambulatory blood pressure (BP), and whose 24-hour ambulatory BP measures 140/90 mm 
Hg or higher for either of the two numbers. Eligible nurses will be defined as nurses who 
are currently working at J&HCHC. Patients will be recruited from J&HCHC via Community 
Health Workers (CHWs). Children (under age 18) and pregnant woman are excluded in this 
study.  
 
Study Procedures 
Based on the J&HCHC’s current practices, all hypertensive patients are required to visit the 
nurse for their regular hypertension monitoring every week. Therefore, all participants in 
this study will be asked to visit J&HCHC once a week for the 6-month period as usual. The 
standard follow-up group will receive the typical regular hypertension care, which 
consisted of nursing assessment, medication management, patient education, follow up and 
continuing care. While the mHealth group will be askto use iHealth BP7-Wireless Blood 
Pressure Wrist Monitor on a daily basis at home, while also visiting the J&HCHC once a 
week to receive regular hypertension care for the 6-month period. Furthermore, all study 
participants will be asked to complete the Medical Outcomes Study 36-Item Short- Form 
Health Survey (SF-36) and Medication Adherence Self-Efficacy Scale (MASES) in-person at 
the beginning and the end of the study.  
 
In this study, a FDA 510K approved device, iHealth BP7-Wireless Blood Pressure Wrist 
Monitor (iHealth Lab Inc.) will be utilized for the mHealth group. This is a fully automatic 
wrist-cuff blood pressure monitor that uses the oscillometric principle to measure blood 
pressure and pulse rate. The monitor works with a mobile app to test, track, and share vital 
blood pressure data. There are no physical risks associated with using the device to 
monitor blood pressure at home. Besides the FDA 510K approval, iHealth BP7-Wireless 
Blood Pressure Wrist Monitor has also CE medical certification (Europe) and ESH 
Certification (European Society of Hypertension). iHealth BP7-Wireless Blood Pressure 
Wrist Monitor works with both Apple and Android devices. IHealth MyVitals is an 

 
application that is downloadable for free at both the Apple Store and Google Play. It 
automatically tracks and analyzes key health vitals all in one place. The measurements 
taken by iHealth BP7-Wireless Blood Pressure Wrist Monitor are automatically stored in an 
easy to read format. It also provides instant access to patient measurements and allows 
patients to see how they are doing and even set optimal goals. 
 
Each iHealth BP7-Wireless Blood Pressure Wrist Monitor user receives a free cloud service 
account.  When patients measure their BP, the BP vital data is then stored and backed up 
securely into the iHealth cloud through their account. The patient and/or healthcare 
provider can log into the cloud account from any device and access the data, regardless of 
where the measurement was taken. Healthcare providers can also create master accounts 
through which they can access all users’ data held under their care. This allows healthcare 
providers to monitor their patients’ blood pressure remotely and intervene in a timely 
fashion.  
 
The research team will hold three training sections prior to the start of the study in order 
to train all the mHealth group participants how to appropriately use the device and 
monitor their BP. Two nurses and six CHWs will also receive training on how to access the 
mHealth group participants’ data in the iHealth cloud account. In addition, the research 
team will do home visits or telephone calls for both group participants each week during 
the study period to assure the study participants followed the study protocol. 
 
 

 
 
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