A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN)
Phase: NA
Conditions: Hypertension, Self-management, Technology, Community-based Participatory Research
Sponsor: Case Western Reserve University

1 
A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN) 
Protocol 1.0 
NCT03724487
Sept 12, 2018

2 
 
Introduction 
 Given the recently published criteria for hypertension (HTN), a blood pressure (BP) >130/80 
mmHg, more Americans are likely to face the challenge of managing this chronic condition.1 It is 
projected that HTN prevalence among U.S. adults will increase from 32% to 46%.2 African 
Americans (AAs) are disproportionately affected by HTN when compared to all other racial-ethnic 
groups,3 and they experience greater disease severity (heart attack, stroke) compared to other 
racial-ethnic groups.3,4 Factors associated with nonadherence to HTN self-management include 
low income, limited access to health care, and or the lack of HTN knowledge,.4-7 Substantial 
evidence has demonstrated the important role of community support in improving patients' 
management of chronic illnesses.8-11 However, such community support programs rarely offer 
technology-based intervention (TBI) as a delivery method to improve HTN self-management.10 
 
Therefore, this proposal constructs community partnerships with civic, health, and social 
organizations (Cleveland Council of Black Nurses and American Heart Association) to modify 
and evaluate TBI to promote medication adherence to antihypertensive therapy and improve BP 
control among AAs with HTN. We propose to adapt and evaluate the efficacy of a multicomponent 
program for HTN self-management referred to as COACHMAN. The proposed project has two 
phases: (1) a community engagement phase, and (2) a pilot evaluation phase. Consistent with the 
principles of community participatory action research,9,12 the project design will include having 
stakeholders provide feedback on the key feature of COACHMAN to enhance its feasibility and 
acceptability. In addition, we will generate data on the efficacy of the intervention that will inform 
stakeholders. We will gain information on how to allocate community resources to promote HTN 
self-management using technology, as well as provide data needed for future federal grant 
proposals. A series of informal sessions and qualitative interviews will be conducted with 
stakeholders and participants in phase one of the proposed project, and a pilot trial of 
COACHMAN will be conducted thereafter on AAs with HTN. 
 
COACHMAN innovatively integrates TBI with community resources and enables participants 
to monitor their blood pressure, access web-based education, mobile application medication 
management, and receive exposure to behavioral counseling from community health worker to 
support self-managing their HTN.12,13 Our central hypothesis is that COACHMAN (evidenced-
based strategies of HTN education, behavioral skills training, and social support) would be more 
effective than usual care at motivating AAs with HTN to improve BP control. A secondary 
hypothesis is that the COACHMAN intervention will result in improved BP control. Thus, the 
aims of this study are: 
 
Aim 1. Identify key content, design, and resources from a community of stakeholders, 
including determining facilitators and barriers of HTN management among AAs that 
will inform the development of COACHMAN using qualitative research methods.  
Aim 2. Evaluate the feasibility and acceptability of COACHMAN to improve BP control.  
Aim 3. Compare the difference in BP control between COACHMAN and EUC. 
 
Impact: The long-term goal of this project is to generate evidence that will inform interventional 
research that reduces the cardiovascular disease risks and suboptimal or poor HTN self-
management in this vulnerable AA population. Cleveland is ideal to conduct this research, as 
Ohio is ranked 15th nationally for prevalence of HTN, with even higher rates observed in AAs.14 

3 
 
A. RESEARCH STRATEGY  
Significance. African Americans (AAs) have higher rates of hypertension (HTN) incidence, as 
well as cardiovascular disease (CVD) morbidity and mortality compared to all other racial-ethnic 
cohorts.1-4 HTN is the most influential contributor to incidence of adverse CVD events.15,16 
COACHMAN targets barriers to hypertension (HTN) knowledge, medication adherence, problem- 
solving skills, patient-provider communication, and social support in an effort to improve blood 
pressure (BP) control. If demonstrated to be effective, COACHMAN will be practical, scalable, 
and highly generalizable to a wide variety of individuals and serve as a linkage from community 
to clinic in the Cleveland area.  
 
 
Barriers to BP control and HTN self-management are multifactorial. Poor adherence to anti-
hypertensive therapy (AHT) is estimated to occur in 43-78% of patients prescribed AHT, with 
50% discontinuation after a year, and notably worse and sooner in AAs.3 Recent research now 
recommends lower BP goals.17,18 Evidence suggests that inability to achieve BP control likely 
arises from a complex interaction of patient, provider, and system-level barriers.6,19 For this 
patient-focused project, the key barriers for BP control and HTN self-management are competing 
health priorities, lack of awareness of HTN knowledge, lack of confidence to self-manage HTN, 
depression, and lack of social support.20 
 
 
The use of technology for self-management of chronic disease is evolving.21 Contrary to the 
popular belief that AAs use less technology,22 AA smartphone use is 81% compared to 74% of the 
total population, and AAs spend close to 56 hours a month using apps or mobile Internet browsers 
on their smartphones.22,23 The proposed COACHMAN intervention represents a conceptual 
progression of the digital age and leverages technology for education and training, including the 
benefits of convenience, cost, and the ability to remotely deliver a highly focused, short-duration, 
HTN self-management intervention. Preliminary Work. In one study, our research team conducted 
a 90-minute focus group session to explore AAs’ (N=21) experiences with using technology 
(mobile devices and apps) for HTN self-management,24,25 The majority of the participants owned 
smartphones and used this technology to communicate; seek, acquire, and share information; 
engage in entertainment; and organize and manage time. Participants expressed concerns about 
not being informed or trained to integrate technology for HTN self-management.26  
 
 
Community engagement in HTN self-management. Substantial evidence has demonstrated the 
importance of community support in improving patients’ management of chronic illnesses.11 
Programs that incorporate multiple strategies such as involving prominent community members 
as well as trustworthy health educators and providing convenient, low cost, and culturally tailored 
interventions are more likely to engage AAs.11,27 Unfortunately, such programs rarely offer 
technology-based intervention (TBI) as a delivery method. We propose to evaluate the feasibility 
and acceptability of a TBI among AAs with HTN. PI Dr. Carolyn Still has already begun informal 
sessions with community partners (National Black Nurses Association and American Heart 
Association) as well as hypertension experts to develop this grant proposal and to obtain input to 
begin the initial design of the TBI for HTN self-management for AAs.  
 
B. INNOVATION. Many communities have begun HTN screening or provider/system initiatives 
to improve BP control. However, such programs have not focused on effective patient engagement 
strategies with TBIs for self-managing HTN. This proposal addresses those gaps by leveraging 

4 
 
successful and replicable community programs with the addition of TBIs to advance the science 
of HTN self-management.    
 
C. 
APPROACH. 
A 
convenience sample of 
AAs with uncontrolled 
HTN will be conducted to 
obtain data on study 
variables and outcomes at 
baseline, 8 weeks, and 12 
weeks. The primary      
outcome is change in BP 
from baseline to three 
months. 
A 
secondary 
outcome 
will 
be 
the 
proportion of participants 
achieving BP < 130/80 
mm Hg at three months. 
Ryan 
and 
Swain’s 
Individual and Family 
Self-Management 
Theory,28 (Figure 1) guides the major constructs of this study. Community stakeholders will be 
engaged throughout the project for continual input to refine and implement study intervention (see 
Statement of Work). The initial phase of this inquiry will begin by conducting informal sessions 
and focus groups to assess motivators as well as barriers to HTN management (Aim 1) followed 
by implementation of COACHMAN. Dr. Cheryl Killion (Nursing Professor at Case Western 
Reserve University) has extensive expertise in community participatory research and will provide 
qualitative method support. 
 
 
Study Intervention. The COACHMAN intervention is comprised of four components: 1) self-
monitoring blood pressure (SMBP), 2) web-based education (adapted from the American Heart 
Association’s Check, Change, Control),12 3) training/support for Medisafe application, and 4) 
nurse counseling. Study investigators will also use forged and ongoing relationships with the 
Cleveland Council of Black Nurses (CCBN) and other community partners to engage in all aspects 
of this study and serve as Community Health Workers (CHWs).10 The Enhanced Usual Care 
(EUC) group will receive one education session on SMBP and printed materials from the 
American Heart Association on “The Facts About High Blood Pressure” and the DASH Diet. All 
participants will receive study-provided automated home BP monitors (Omron 10 Series). 
 
 
Setting and Sample. Given that this is a pilot study, a sample size of 40 is considered adequate. 
Participant inclusion criteria are as follows: (1) self-identifying as AA; (2) aged 30 years or older; 
(3) diagnosed with HTN (BP > 140/90 mm Hg) and taking at least one antihypertensive 
medication; (4) able to read/understand English; and (5) own a smartphone with a data plan, with 
the capability to download the Medisafe app and view videos. Exclusion criteria are: (1) history of 
cognitive impairment, and (2) currently using medication management app. 
 
 
Figure 1: Conceptual Framework 

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Recruitment and Retention. Various recruitment strategies such as fliers, brochures, and target 
ads through social media platforms (Facebook, ResearchMatch.org), as well as advertisements at 
community events and clinics,29 will be used simultaneously. In addition, our community partners 
will assist recruitment. Our study population will be recruited from University Hospitals and from 
community outreach engagement. We anticipate limited difficulty in recruiting participants due to 
the Dr. Still’s experience in clinical research and long-term working relationship with the 
participants and providers, as well as continued work with other cardiovascular trials. We will 
recruit three participants per week over a 4-month (December-April) period. While Dr.  Still has 
experience with recruiting and managing clinical trials, she is an Early Stage Investigator (without 
NIH grant awards) in her second year as an Assistant Professor (tenure track) in the School of 
Nursing at Case Western Reserve University.  
 
Variable 
Measure 
Time of Measure 
 
 
Baseline 
8 
Weeks 
12 
Weeks 
Health Outcomes  
 
 
 
 
BP Change 
BP <140/90 mmHg 
X 
X 
X 
Health-related QOL 
PROMIS Global Health-10,30 
X 
 
X 
Secondary 
Health 
Outcomes 
 
 
 
 
BP Control 
At least 65% of participants with 
BP control<140/90 mmHg 
 
 
X 
Behavior Outcomes 
 
 
 
 
Medication Adherence  
Hill-Bone Compliance Scale,31 
X 
X 
X 
Patient Activation 
Patient Activation Measure Short 
Form-PAM-13,32 
X 
X 
X 
Self-Management 
Outcomes 
 
 
 
 
HTN 
knowledge 
and 
Awareness 
Hypertension 
Knowledge-Level 
Scale-HK-LS,33 
X 
 
X 
Self-efficacy 
Self-efficacy for Managing Chronic 
Disease,34 
X 
 
X 
Technology Use  
System Usability Scale-SUS,35 
 
X 
X 
Technology Adoption 
Mobile Application Rating Scale-
MARS,36 
 
X 
X 
Contextual Factors 
 
 
 
 
Demographics 
Demographic Questionnaire 
X 
 
 
Hypertension History 
Charleston Morbidity Index,37 
X 
 
 
Biometric 
Health 
Screening 
Height and Weight, BMI, Kidney 
function, proteinuria 
X 
 
X 
Social Support  
Duke Subjective and Instrument 
Support,38 
X 
X 
X 
Spirituality 
The Daily Spiritual Experience 
Scale,39 
X 
X 
X 
Depression 
PROMIS Depression Scale-Short 
Form,40 
X 
X 
X 
 

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Data Collection and Procedures. Study variables, measures, and data collection points are shown 
in Table 1 (page 5). After consent is obtained, participants will be randomized to COACHMAN or 
EUC with a 1:1 ratio. At baseline and 12 week visits, we will conduct biometric health screening 
test (height, weight, and blood samples). A trained RA will provide subjects assigned to 
COACHMAN a structured 30-minute training session on how to use study website and Medisafe 
on smartphone. For those subjects assigned to EUC, the RA will provide education materials. 
Follow-up phone sessions on medication adherence and additional training will be provided by the 
CCBN trained as CHWs.  
Fidelity of the intervention “dose” (delivered, received, enacted) will be monitored regularly 
throughout the study by obtaining measures of subject responses to medication reminders, receipt 
of behavior change, and attendance to follow-up visits.  
Statistical Analysis. For Aims 1 and 2, focus group sessions and key informant interviews will be 
transcribed verbatim and analyzed with NVivo 10 or a similar software package using principles 
of inductive content analysis. For Aim 3, the primary analysis compares BP levels between the 
COACHMAN intervention and the EUC group across three time points (baseline, 8, and 12 
weeks). We will use a repeated measures analysis of variance (RMANOVA) built around a two 
group by three time points to assess mean differences across time, group differences, and the 
interaction of time X group.42  
 Study Timeline. Months 1-2: Project start-up, finalize online web-based system, begin 
recruitment. Months 2-5: Recruitment, randomization, enrollment; begin intervention delivery; 
Months 3-9: Continue intervention delivery; data collection and system monitoring and retention; 
Months 9-12: Data cleaning, analysis, dissemination.  
Potential Problems and Alternative Strategies. Due to the pilot nature of this study, each 
participant will be required to use their own data plan. As noted in preliminary studies, a majority 
of participants own or have cell phones in our qualitative study. Thus, we expect few exclusions 
related to cell phone ownership.  Participants will receive a total of $215, which is intended to 
cover any costs incurred from cell phone usage, and overall study participation. This pilot trial is 
intended to inform the design of a larger clinical trial, including its scalability, especially in terms 
of costs that are not more than we anticipate, or pose a problem for participant or retention. Future 
trials will provide study phones with prepaid data plans for those individuals with limited 
resources. 

7 
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