Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction
Phase: NA
Conditions: Stroke Prevention, Blood Pressure, Telemedicine, Psychosocial Impairment
Sponsor: The University of Texas Health Science Center, Houston

1 
IRB APPROVAL DATE: 11/10/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Title Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction 
 
NCT03923790 
 
Version Date:11/10/2020 
 
 

2 
IRB APPROVAL DATE: 11/10/2020 
 
Protocol Title: Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction 
 
Protocol Version 1.6 
 
Principle Investigator: Anjail Sharrief MD MPH 
 
Co-Investigators: 
Sean Savitz MD 
Jon Tyson MD, MPH 
Munachi Okpala MSN, C-NP 
Nour Abdelhamid 
Teresa Allison 
Charles Green 
 
Research Associates 
Evelyn Hinojosa 
Sophie Samuel 
Thuy Nguyen 
Kim Vu 
Caitlynn Carter 
LaTonya Bryant 
Teresa Allison 
 
Research Coordinator 
Gabretta Cooksey 
Evelyn Hinojosa 
Audrey Sarah Cohen 
 
 
Population: 
Patients discharged home from Memorial Hermann Hospital 
 
Number of Sites: 
One – UT Houston 
Study Duration: 
30 months 
Subject Duration: 
6 months 
 
 
Background and Significance 
 
Improvements in stroke prevention, acute treatment, and organized systems of care for acute 
stroke are all contributing to declines in stroke mortality observed over the past decade.1 
However, with increasing survival after stroke and expected increases in stroke incidence related 
to population aging, the prevalence of stroke is projected to increase by 3.4 million in 2030.1, 14 
Despite these projections, there has been little research on post-acute care models for stroke 
survivors. 
IRB NUMBER: HSC-MS-18-0925 

IRB NUMBER: HSC-MS-18-0925 
IRB APPROVAL DATE: 11/10/2020 
2 
 
Stroke incidence, mortality, and recurrence vary by race.1, 15 African Americans, Hispanic 
Americans, and American Natives have higher risk of stroke than Caucasian Americans.8-11, 16 
Projected increases in stroke prevalence also vary by racial and ethnic category, with the largest 
rises expected in men and women of Hispanic ethnicity and African American race.14 Systems of 
care for stroke survivors must be developed with mechanisms to identify and address racial 
disparities in stroke outcomes. 
 
Hypertension is the most important risk factor for ischemic stroke and hemorrhagic stroke.1 
Small reductions in systolic BP after stroke (5 mmHg) are associated with greater than 20% 
reduction in recurrent stoke risk.3 However, available data suggests that hypertension remains 
poorly controlled after the incident stroke. A report from the Reasons for Geographic and Racial 
Differences in Stroke (REGARDS) observational study revealed that risk factor awareness and 
control were poor in participants who self-reported a history of stroke.5 Only 66.7% of stroke 
survivors had controlled BP, and African American stroke survivors were more likely to have 
undiagnosed hypertension and uncontrolled hypertension (among those treated) than White 
stroke survivors. Baseline visit data from the Secondary Prevention of Small Subcortical Strokes 
(SPS3) trial support REGARDs data. Among US participants, 44% of ischemic stroke survivors 
had controlled BP three months after stroke and African Americans were more likely to have 
uncontrolled BP.7 Investigators from The Differences in the Imaging of Primary Hemorrhage 
based on Ethnicity or Race (DECIPHER) project reported poor BP control 30 days and 1 year 
after hemorrhagic stroke.6 In this study, BP was controlled (less than 140/90) for 47.2% of 
participants at 30 days and for 41.7% one year after stroke, and BP control was poor in African 
Americans. 
 
Factors associated with BP control in African Americans have been studied extensively. These 
include social and economic factors, condition and therapy-related factors, health care system 
and clinician factors, patient-related factors, and patient-physician relationship factors.17, 18 
Uncontrolled BP may be specifically related to medication cost, access to healthcare, access to 
providers, medication complexity, patient beliefs and perceptions, patient educational 
achievement and socioeconomic status, patient response to and side effects of medications, 
sodium intake, patient depression and demoralization, perceived racism and discrimination, 
social networks and support, physician prescribing practices, physician communication and 
empathy, neighborhood segregation, and others.18-25 
 
There are fewer studies of uncontrolled BP in stroke survivors overall, but among published 
studies, race, socioeconomic status, medication adherence, self-efficacy, marital status, and level 
of independence have been associated with BP control.5, 7, 26-28 Access to care, medication 
adherence, and medication prescribing patterns do not fully explain disparities in BP control in 
stroke survivors. Among 2972 insured stroke survivors followed in the Kaiser Quality 
Improvement in Stroke Prevention (QUISP) study, odds of BP control in African Americans was 
41% less than that observed in White Americans despite similar rates of medication adherence 
and attendance at outpatient visits and higher median number of medications.29 Disparities in 
control may be explained by physiologic factors such as duration of hypertension, differential 
response to medications according to race, and medical comorbidities such as sleep apnea and 
chronic kidney disease.30-33 The presence and differential impact of post-stroke depression, 
cognitive impairment, social isolation, and caregiver burden may add to the complexity of BP 
control in hypertensive stroke survivors. 

IRB NUMBER: HSC-MS-18-0925 
IRB APPROVAL DATE: 11/10/2020 
3 
 
The most effective interventions for BP control in the general population of African Americans 
target more than one barrier to control. Successful interventions include those that incorporate a 
team-based approach to care, that utilize a pharmacist or health professional other than the 
primary care provider, and those that utilize telehealth and home BP monitoring.21, 24, 34-39 
Among stroke patients, isolated behavioral and educational interventions have not been shown to 
impact BP control.12 Organizational interventions, such as those incorporating collaborations 
among multidisciplinary teams, integrated care services, revision of pharmacists’ roles, and/or 
knowledge and quality management protocols show evidence supporting mild improvements in 
BP control.13, 40 To our knowledge, no studies have shown benefit for reducing disparities in BP 
control among stroke survivors. 
 
We will implement a pilot trial of a telehealth intervention for BP control at the Memorial 
Hermann Hospital-TMC campus focusing on patients at highest risk for uncontrolled blood 
pressure. The intervention will address general and stroke-related factors associated with racial 
disparities in BP control. We will assess feasibility of implementation of the trial and will use the 
measures and outcomes assessed in the pilot to examine knowledge gaps. 
 
 
Specific Aims 
 
Aim 1 will focus on the identification of hospitalized ischemic and hemorrhagic stroke patients at 
risk for uncontrolled BP after hospital discharge. 
• 
We will develop a checklist to be completed by the discharge nurse navigator or social worker for 
early identification of stroke inpatients at risk for uncontrolled BP. The checklist will include 
existing information from the patient medical record (race and insurance) and clinical information 
including stroke type and etiology in order to document the presence of known risk factors for 
uncontrolled BP. Key known risk factors include uninsured status, Medicaid payer status, 
hypertensive intracerebral hemorrhage, small vessel ischemic stroke, and patients on ≥ 2 
hypertensive medications. The checklist will be used to determine which patients should be 
screened for study eligibility. 
 
Aim 2 will shift from the planning portion of the study to the pilot trial, which will simulate a larger 
trial and allow evaluation of intervention components and outcome measures and estimation of 
effect sizes and attrition rates. 
• 
Aim 2a: To examine the suitability of key study components and outcome measures intended for 
a future larger trial, we will randomize 50 patients to the intervention and 50 patients to usual 
care. We will determine the proportion of randomized patients who complete the intervention 
visits, the proportion of patients (by group) who complete the outcome assessments, and barriers 
to intervention and 6-month outcome assessment completion. 
• 
Aim 2b: To examine the suitability and ease of use of the telehealth tool and effectiveness of 
components of the intervention, we will develop a CRF to capture patient feedback to be 
integrated into the design of the future, larger trial. 
• 
Aim 2c: To estimate key parameters needed to adequately power a larger randomized trial, we 
will calculate the effect of the intervention on the ambulatory systolic blood pressure at 6 months 
relative to usual care; the probability using Bayesian methods that this effect size exists; the 
enrollment rate; and the attrition rate. 
 
Study Procedures: 
 
Eligibility Criteria 

IRB NUMBER: HSC-MS-18-0925 
IRB APPROVAL DATE: 11/10/2020 
4 
 
Ischemic and hemorrhagic stroke patients (N=100) identified as potentially eligible by the 
checklist (at least one of the following high risk criteria: uninsured, Medicaid payer status, small 
vessel ischemic stroke, hypertensive ICH, planning on discharging on ≥2 hypertension 
medications) will be eligible if they also meet the following inclusion criteria: age ≥ 18; presence 
of hypertension (by clinical history or hospital BP ≥130/80 mmHg on two occasions); plan to 
discharge home after stroke; ability to provide consent (patient or caregiver); ability to 
communicate in English. Exclusion criteria will include modified Rankin scale > 4 at the time of 
enrollment (severe disability), life expectancy < 1 year or terminal illness, eGFR < 30 at time of 
discharge, pregnancy, symptomatic flow limiting carotid stenosis without plan for intervention; 
urine toxicology positive for cocaine or methamphetamine or history of use; long-term BP goal 
≥ 130/80 mmHg according to clinical team; and inability to comply with study procedures * ( 
severe expressive language impairment, deafness, blindness, or other physical; cognitive; 
or social issues limiting ability to adhere to procedures). 
 
 
 
 
Screening and Randomization 
Sequential eligible patients will be approached prior to discharge to assess their interest in 
participating in the trial. Informed consent will be obtained from patients. Caregivers will 
provide consent for patients with aphasia who are otherwise eligible. Baseline assessments of 
socioeconomic status (education and income), medication adherence, medication adherence self- 
efficacy, cognition, and social support will be completed prior to randomization. We will use an 
internet-based system to randomize patients (1:1) to intervention versus usual care using a block 
design with permuted blocks of 2 to 4. The randomization allocation sequence will be developed 
by a statistician not involved in enrollment procedures. We will stratify based on insurance 
status (insured vs uninsured) and race (African American vs other) to assure that groups are 
balanced with respect to baseline risk. Consort criteria for the design of parallel group 
randomized trials will be followed. 
 
Intervention 
Components of the telehealth intervention will target behaviors associated with racial disparities 
(African American focused) in BP control. At the time of discharge, intervention patients will 
receive a package containing an iPad (with a data plan) and a blue tooth enabled blood pressure 
monitor that allows automatic transmission of encrypted BP data to the study team 
(QardioARM). 39 Patients will be allowed to use their own smart device if it is compatible with 
the BP device). Patients and/or caregivers will be instructed in use of equipment and the first 
video telehealth visit will be arranged. They will complete questionnaires including a depression 
screen, a dietary assessment, a cognitive screen, and a sleep apnea screen prior to discharge. 
Patients will receive a phone call at 72 hours by the discharge nurse navigator or social worker 
(standard of care) to assure that they have received their medications and follow-up 
appointments. The first telehealth visit will occur 7 days after discharge. A stroke prevention- 
trained nurse practitioner (NP) or MD, social worker (SW), and pharmacist will attend this 
video telehealth visit. The NP will review the participant’s hospital records and depression, 
dietary, and sleep apnea screens, will reinforce the care plan based on patient-specific needs. The 
NP or MD will counsel patients on salt reduction, the Mediterranean diet, and the importance of 
diet and exercise for stroke prevention. The NP (or MD) and pharmacist will review the BP data 
to determine the need for medication adjustment. The pharmacist will discuss side effects and 

IRB NUMBER: HSC-MS-18-0925 
IRB APPROVAL DATE: 11/10/2020 
5 
 
interactions. Treatment of hypertension and selection of BP lowering medications will be in 
accordance with latest published guidelines for BP management.42. The SW will assess the need 
for medication assistance and other resources. The care plan will be shared with primary care 
providers (PCP) and patients will be referred to a PCP if they do not have one. The SW will 
assist uninsured patients in applying for Texas County Indigent Care programs. 
 
Participants will be prompted to transmit BP logs through the telemonitoring device every 2 
weeks until average BP is < 130/80, then monthly thereafter. Uncontrolled BP will prompt a call 
from the pharmacist to discuss medication adherence and the need for further titration. 
Subsequent video telehealth visits for intervention patients will be attended by the NP (or MD) 
and pharmacist 1 month, 3 months, and 5 months after enrollment. Care plans will be reviewed 
and medication and lifestyle adherence will be assessed. Medications will be adjusted as 
appropriate. Participants will complete electronic health care utilization and recurrent vascular 
CRFs using the iPad at 3 months and 6 months (final outcome) Participants will receive 
educational messaging once every other week throughout the study period. Messages will be sent 
to the participants’ cellular phones. The messages will contain one of the following: a reminder 
to monitor BP, information from about lifestyle and diet for BP reduction, or a message from the 
pharmacist about medication adherence. Final outcome assessments (detailed below) will occur 
at 6 months. 
 
Uninsured Patients (5/8/2019): 
An Internal Medicine Consultant will be utilized as an advisor when complex medical non- 
neurologic issues arise for patients who do not yet have a primary care provider. The consultant 
will join the telehealth visits as appropriate to provide recommendations for management of 
complex medical issues that can be managed in the ambulatory setting. 
 
 
Usual Care (Control) Group 
Participants randomized to usual care will complete questionnaires including a depression 
screen, a dietary assessment, a cognitive screen, and a sleep apnea screen prior to discharge. A 
summary of the assessments will be given to the patient and they will be instructed to follow-up 
with their PCP and to monitor their BP. They will be contacted by the discharge nurse navigator 
or social worker at 72 hours to as per usual care to determine if they have received their 
medication and made their appointments. They will be offered a standard of care hospital follow 
up appointment with a stroke neurologist or nurse practitioner at the clinic. The RC will contact 
participants at 30-days, 90-days, 150-days to encourage continued participation. The RC will 
complete a telephone CRFs to obtain information about readmissions, hospital visits, and 
recurrent vascular events at 30 days and 90 days. Final outcome assessments (detailed below) 
will occur at 6 months. 
 
Weekend and Holiday Discharges (Both Groups) 
Eligible patients may be consented during the week but subsequently discharged on a weekend 
or holiday when study staff are not available to deliver equipment or provide counseling. Patients 
will be randomized on the day of discharge, however, if they are randomized to the intervention 
group, the telemonitoring equipment will be sent to them (in person or via Fedex) on the first 
business day after discharge. The pharmacist will provide counseling about discharge 
medications on the first business day after discharge. The nurse navigator or social worker call 
will take place at 72 hours after discharge as per usual. 

IRB NUMBER: HSC-MS-18-0925 
IRB APPROVAL DATE: 11/10/2020 
6 
 
Variables and Outcome Assessment 
Baseline demographic and clinical characteristics will be abstracted from inpatient charts, 
supplemented by a study CRF collected prior to randomization. Demographic variables will 
include age, sex, self-reported race, self-reported ethnicity, level of education, household 
income, insurance status, and marital status. Clinical variables will include stroke subtype, stroke 
etiology, prior stroke or TIA, treatment with IV tPA, endovascular therapy, admission National 
Institutes of Health Stroke Score, pre-stroke modified Rankin scale, presence of stroke risk 
factors (hypertension, diabetes mellitus, tobacco use, hyperlipidemia, obstructive sleep apnea, 
atrial fibrillation, coronary artery disease, systolic heart failure, substance abuse) other medical 
co-morbidities (obesity, chronic kidney disease), Barthel Index at baseline, Body Mass Index 
(BMI) at discharge, and the number of BP medications at discharge. Psychological, cognitive, 
and behavioral variables will include depression (Patient Health Questionaire-9); anxiety 
(Generalized Anxiety Disorder-7); cognitive impairment (Montreal Cognitive Assessment), self- 
efficacy (Medication Adherence Self-Efficacy Scale - MASES); medication adherence (Morisky 
Medication Adherence Scale - MMAS); and social support (Stroke Social Network Scale).43-47 
 
Primary Clinical Outcomes 
The primary clinical outcome will be the daytime ambulatory systolic blood pressure at 6 
months. Secondary clinical outcomes will include the following: daytime ambulatory diastolic 
blood pressure, nighttime ambulatory systolic and diastolic blood pressure; BMI at 6 months; 
recurrent vascular event rate (stroke, myocardial infarction, acute cardiac death); and acute 
healthcare utilization rate (hospital readmission and acute care visits to emergency room and/or 
urgent care).42 The 6- month behavioral outcomes will include change in self-efficacy for taking 
medication as prescribed, medication adherence, and caregiver burden. Patient satisfaction will 
be assessed using scores obtained from the Patient Telemedicine Satisfaction Survey.48 
 
Outcome Assessments 
All enrolled patients will have final 6-month outcomes either in-clinic or by home visit with the 
research coordinator. Final BP will be assessed using a validated ambulatory blood pressure 
monitor (ABPM). The patient will be fitted with the ABPM at the final visit and will receive a 
Fedex envelope in which to return the ABPM after 24 hours. Weight and height will be assessed 
for BMI. Final healthcare utilization and recurrent vascular event CRFs will be completed and 
behavioral outcomes will be assessed using MASES, MMAS, and the Zarit Caregiver Burden 
Questionnaire.44, 45, 50 Satisfaction with telehealth visits will be assessed using the Telemedicine 
Satisfaction Survey (intervention arm). Patients will be compensated for final study visits ($50). 
 
Sample Size Estimation and Statistical Approach 
 
Sample size estimates are based on feasibility of recruitment in a 1 year study period and 
anticipated attrition rates, based on our experience recruiting similar patient populations. 
Estimates derived from the current pilot trial in the form of posterior distribution will form the 
basis for simulations in planning the subsequent, larger, confirmatory trial. 
 
Descriptive statistics will characterize the proportion of randomized patients completing 
assessments at baseline, 7 days (intervention), 1 month (intervention), 3 months (intervention), 
5-months (intervention) and 6 months (all). Tabulation of obstacles to the intervention and 
completion of the outcome assessments will permit appropriate revision of the intervention for 
the subsequent, larger confirmatory trial. Descriptive statistics will characterize scores on the 
Telemedicine Satisfaction Questionnaire. Inspection of patterns of patient responses to specific 

IRB NUMBER: HSC-MS-18-0925 
IRB APPROVAL DATE: 11/10/2020 
7 
 
items will permit modification of the telemedicine approach for the subsequent, larger, 
confirmatory trial. Generalized linear modeling will evaluate the primary clinical outcome 
difference in ambulatory daytime systolic BP between the two groups 6 months post-discharge 
as a function of treatment, race, the interaction of treatment and race, the interaction of insurance 
status and race. Secondary analyses will evaluate nighttime systolic, and daytime and nighttime 
diastolic ambulatory BP, BMI, recurrent vascular event rate, acute healthcare utilization rate, 
self-efficacy, medication adherence, and caregiver burden. 
 
Risks and Benefits: 
 
Usual care participants may be at higher risk for complications associated with elevate blood 
pressure, especially if they do not establish care with a primary provider. However, this is not 
more risk than what occurs typically. In fact, they will be offered a standard of care hospital 
follow up visit with the clinic and with 6 month study blood pressure assessments, usual care 
patients may have more MD contact, and opportunities for referral to primary care, than typical. 
 
There is potential for adverse effects associated with aggressive blood pressure reduction. We 
have chosen a conservative and currently AHA recommended BP goal and will monitor for 
hypotension, syncope, and falls that may result from hypotension. These are included these as 
safety outcomes. 
 
Participants may be burdened by numbers of surveys and telephone calls. We will give breaks 
and minimize number of forms requested to obtain necessary data. Telephone calls will be brief. 
 
Another potential risk of this study is breach of confidentiality. This risk will be minimized with 
confidentiality measures described below. 
 
All patients, including usual care group, may benefit from ambulatory blood pressure 
assessments and communication with primary care providers about risk factor goals. 
More patients will be given access to specialty care (uninsured and underinsured) than would be 
typically. 
 
Costs, Reimbursement, and Compensation: 
Participants will receive 50 dollars for time and travel associated with the 6-month visit. They 
will also receive a parking voucher at for their 6 month visit. 
 
Human Subject Issues: 
Consent will be obtained from patients and authorized representatives. 
 
Patient Confidentiality and Data Safety: 
Patients will be assigned a code which will be kept in a password protected excel spreadsheet 
with patient name, date of initial hospital visit, and medical record number. Clinical data will be 
entered into RedCAP using patient code. Only the Principle investigator and data abstractors will 
have access to the codebook with patient identifiers. 
 
The file containing PHI will be deleted 5 years after completion of the study. 

IRB NUMBER: HSC-MS-18-0925 
IRB APPROVAL DATE: 11/10/2020 
8 
 
1. 
Mozaffarian, D., E.J. Benjamin, A.S. Go, et al., Heart disease and stroke statistics-2015 
update: a report from the american heart association. Circulation, 2015. 131(4): p. e29- 
e322. 
2. 
Ovbiagele, B., L.B. Goldstein, R.T. Higashida, et al., Forecasting the future of stroke in 
the United States: a policy statement from the American Heart Association and American 
Stroke Association. Stroke, 2013. 44(8): p. 2361-75. 
3. 
Cruz-Flores, S., A. Rabinstein, J. Biller, et al., Racial-ethnic disparities in stroke care: 
the American experience: a statement for healthcare professionals from the American 
Heart Association/American Stroke Association. Stroke, 2011. 42(7): p. 2091-116. 
4. 
Rosamond, W.D., A.R. Folsom, L.E. Chambless, et al., Stroke incidence and survival 
among middle-aged adults: 9-year follow-up of the Atherosclerosis Risk in Communities 
(ARIC) cohort. Stroke, 1999. 30(4): p. 736-43. 
5. 
Sacco, R.L., B. Boden-Albala, R. Gan, et al., Stroke incidence among white, black, and 
Hispanic residents of an urban community: the Northern Manhattan Stroke Study. Am J 
Epidemiol, 1998. 147(3): p. 259-68. 
6. 
Kissela, B., A. Schneider, D. Kleindorfer, et al., Stroke in a biracial population: the 
excess burden of stroke among blacks. Stroke, 2004. 35(2): p. 426-31. 
7. 
Schieb, L.J., C. Ayala, A.L. Valderrama, and M.A. Veazie, Trends and disparities in 
stroke mortality by region for American Indians and Alaska Natives. Am J Public Health, 
2014. 104 Suppl 3: p. S368-76. 
8. 
Morgenstern, L.B., M.A. Smith, L.D. Lisabeth, et al., Excess stroke in Mexican 
Americans compared with non-Hispanic Whites: the Brain Attack Surveillance in Corpus 
Christi Project. Am J Epidemiol, 2004. 160(4): p. 376-83. 
9. 
Petty, G.W., R.D. Brown, Jr., J.P. Whisnant, et al., Ischemic stroke subtypes : a 
population-based study of functional outcome, survival, and recurrence. Stroke, 2000. 
31(5): p. 1062-8. 
10. 
Hackam, D.G. and J.D. Spence, Combining multiple approaches for the secondary 
prevention of vascular events after stroke: a quantitative modeling study. Stroke, 2007. 
38(6): p. 1881-5. 
11. 
Group, P.C., Post-stroke antihypertensive treatment study. A preliminary result. Chin 
Med J (Engl), 1995. 108(9): p. 710-7. 
12. 
Liu, L., Z. Wang, L. Gong, et al., Blood pressure reduction for the secondary prevention 
of stroke: a Chinese trial and a systematic review of the literature. Hypertens Res, 2009. 
32(11): p. 1032-40. 
13. 
Group, P.C., Randomised trial of a perindopril-based blood-pressure-lowering regimen 
among 6,105 individuals with previous stroke or transient ischaemic attack. Lancet, 
2001. 358(9287): p. 1033-41. 
14. 
Brenner, D.A., R.M. Zweifler, C.R. Gomez, et al., Awareness, treatment, and control of 
vascular risk factors among stroke survivors. J Stroke Cerebrovasc Dis, 2010. 19(4): p. 
311-20. 
15. 
White, C.L., P.E. Pergola, J.M. Szychowski, et al., Blood pressure after recent stroke: 
baseline findings from the secondary prevention of small subcortical strokes trial. Am J 
Hypertens, 2013. 26(9): p. 1114-22. 
16. 
Zahuranec, D.B., J.J. Wing, D.F. Edwards, et al., Poor long-term blood pressure control 
after intracerebral hemorrhage. Stroke, 2012. 43(10): p. 2580-5. 
17. 
Zakopoulos, N., K. Spengos, G. Tsivgoulis, et al., Assessment of blood pressure control 
in hypertensive stroke survivors: an ambulatory blood pressure monitoring study. Blood 
Press Monit, 2006. 11(5): p. 235-41. 

IRB NUMBER: HSC-MS-18-0925 
IRB APPROVAL DATE: 11/10/2020 
9 
 
18. 
Kernan, W.N., B. Ovbiagele, H.R. Black, et al., Guidelines for the prevention of stroke in 
patients with stroke and transient ischemic attack: a guideline for healthcare 
professionals from the American Heart Association/American Stroke Association. Stroke, 
2014. 45(7): p. 2160-236. 
19. 
Ireland, S.E., H.M. Arthur, E.A. Gunn, and W. Oczkowski, Stroke prevention care 
delivery: predictors of risk factor management outcomes. Int J Nurs Stud, 2011. 48(2): p. 
156-64. 
20. 
Dave, G.J., D.L. Bibeau, M.R. Schulz, et al., Predictors of uncontrolled hypertension in 
the Stroke Belt. J Clin Hypertens (Greenwich), 2013. 15(8): p. 562-9. 
21. 
Aronow, W.S., J.L. Fleg, C.J. Pepine, et al., ACCF/AHA 2011 expert consensus document 
on hypertension in the elderly: a report of the American College of Cardiology 
Foundation Task Force on Clinical Expert Consensus Documents developed in 
collaboration with the American Academy of Neurology, American Geriatrics Society, 
American Society for Preventive Cardiology, American Society of Hypertension, 
American Society of Nephrology, Association of Black Cardiologists, and European 
Society of Hypertension. J Am Soc Hypertens, 2011. 5(4): p. 259-352. 
22. 
Park, I.U. and A.L. Taylor, Race and ethnicity in trials of antihypertensive therapy to 
prevent cardiovascular outcomes: a systematic review. Ann Fam Med, 2007. 5(5): p. 
444-52. 
23. 
Wright, J.T., Jr., J.K. Dunn, J.A. Cutler, et al., Outcomes in hypertensive black and 
nonblack patients treated with chlorthalidone, amlodipine, and lisinopril. JAMA, 2005. 
293(13): p. 1595-608. 
24. 
Bradley, T.D. and J.S. Floras, Obstructive sleep apnoea and its cardiovascular 
consequences. Lancet, 2009. 373(9657): p. 82-93. 
25. 
Diminic-Lisica, I., B. Popovic, J. Rebic, M. Klaric, and T. Franciskovic, Outcome of 
treatment with antidepressants in patients with hypertension and undetected depression. 
Int J Psychiatry Med, 2014. 47(2): p. 115-29. 
26. 
Lager, K.E., A.K. Mistri, K. Khunti, et al., Interventions for improving modifiable risk 
factor control in the secondary prevention of stroke. Cochrane Database Syst Rev, 2014. 
5: p. CD009103. 
27. 
Baylor, C., K.M. Yorkston, M.P. Jensen, A.R. Truitt, and I.R. Molton, Scoping review of 
common secondary conditions after stroke and their associations with age and time post 
stroke. Top Stroke Rehabil, 2014. 21(5): p. 371-82. 
28. 
Hackett, M.L., S. Kohler, J.T. O'Brien, and G.E. Mead, Neuropsychiatric outcomes of 
stroke. Lancet Neurol, 2014. 13(5): p. 525-34. 
29. 
Lisabeth, L.D., B.N. Sanchez, J. Baek, et al., Neurological, functional, and cognitive 
stroke outcomes in Mexican Americans. Stroke, 2014. 45(4): p. 1096-101. 
30. 
Ayerbe, L., S. Ayis, C.D. Wolfe, and A.G. Rudd, Natural history, predictors and 
outcomes of depression after stroke: systematic review and meta-analysis. Br J 
Psychiatry, 2013. 202(1): p. 14-21. 
31. 
Morgenstern, L.B., B.N. Sanchez, L.E. Skolarus, et al., Fatalism, optimism, spirituality, 
depressive symptoms, and stroke outcome: a population-based analysis. Stroke, 2011. 
42(12): p. 3518-23. 
32. 
Chollet, F., J. Tardy, J.F. Albucher, et al., Fluoxetine for motor recovery after acute 
ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol, 2011. 
10(2): p. 123-30. 
33. 
Morisky, D.E., A. Ang, M. Krousel-Wood, and H.J. Ward, Predictive validity of a 
medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich), 
2008. 10(5): p. 348-54. 

IRB NUMBER: HSC-MS-18-0925 
IRB APPROVAL DATE: 11/10/2020 
10 
 
34. 
Williams, L.S., E.J. Brizendine, L. Plue, et al., Performance of the PHQ-9 as a screening 
tool for depression after stroke. Stroke, 2005. 36(3): p. 635-8. 
35. 
Gershon, R.C., J.S. Lai, R. Bode, et al., Neuro-QOL: quality of life item banks for adults 
with neurological disorders: item development and calibrations based upon clinical and 
general population testing. Qual Life Res, 2012. 21(3): p. 475-86. 
36. 
Weinick, R.M., D.D. Quigley, L.A. Mayer, and C.D. Sellers, Use of CAHPS patient 
experience surveys to assess the impact of health care innovations. Jt Comm J Qual 
Patient Saf, 2014. 40(9): p. 418-27. 
37. 
Lorig KR, S.A., Ritter P, Gonzalez V, Laurent DD, Lynch J. , Outcome measures for 
health education and other health care interventions. . 1996, Thousand Oaks, CA: SAGE 
Publications. 
38. 
Warren-Findlow, J., R.B. Seymour, and L.R. Brunner Huber, The association between 
self-efficacy and hypertension self-care activities among African American adults. J 
Community Health, 2012. 37(1): p. 15-24. 
39. 
Boston, R.C. and A.E. Sumner, STATA: a statistical analysis system for examining 
biomedical data. Adv Exp Med Biol, 2003. 537: p. 353-69.