Operating Under Resilience (OUR) Project: Stress and Emotion Management for Black/African American Women With Hypertension In a Covid--19 Social Distancing Society
Phase: NA
Conditions: Stress, Psychological
Sponsor: Ohio State University

 
Official Title: OUR Stress/ Emotion Management for 
Black/African American Women With 
Hypertension 
NCT Number: NCT04526145 
Document Name: Study Protocol and Statistical Analysis Plan  
Document Date: October 1, 2021 
 
 
 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
 
Operating Under Resilience (OUR) Project: Stress and emotion Management for Black/African 
American Women with Hypertension In a Covid-19 Social Distancing Society 
 
Covid-19 has brought to light the chronic stress of socioeconomic disadvantage experienced by African 
Americans. Thirty percent of Covid-19 patients are African Americans, despite the fact African Americans make 
up around 13% of the population in the United States. The body’s response to chronic stress results in systemic 
inflammation and adverse cardiovascular and cognitive health outcomes.1,2 Chronic stress is an important risk 
factor for poor blood pressure control1 and cognitive decline.3 African American (Black) women are at even 
greater risk of cognitive decline due to a high prevalence of hypertension, obesity, sleep disturbance, unhealthy 
eating, and exposure to adversity in the form of discrimination stress.4 Emotional dysregulation, as a result of 
chronic stress, also contributes to cardiovascular disease, anxiety, and depression.5-8 In previous work  
Co-Created Health Education InterventioN (Co-CHIN) study was created and implemented to promote resilience 
and healthy behaviors in Black women with hypertension. We collaborated with hypertensive black adults (age 
≥ 60) to develop Co-CHIN for hypertension self-care management.9-11 The Co-CHIN intervention was feasible 
and acceptable in several ways: We rapidly recruited participants (31 black adults in less than 30 days; 87% 
women), zero participants dropped out, and 86.7% of participants self-reported that Co-CHIN was applicable to 
their lifestyle.  Ninety-three percent of the women attended all four weekly Co-CHIN sessions. Knowing that lack 
of physical activity is a risk factor for poor health outcomes, we enhanced Co-CHIN to incorporate physical 
activity goals into daily routines.  
Covid-19 is an additional stressor Black women have to deal with that may interfere with hypertension 
self-care management. Social connectedness is a source of resilience for Black women to promote mental and 
physical health.  Unfortunately, in the face of the Covid-19 pandemic, social distancing is a challenge further 
isolating Black women from their networks. How do we promote social connectedness to manage stress and 
emotional well-being in a social-distancing society for Black women with hypertension? We proposed a 
synchronous web-based version of Enhanced Co-CHIN (eCo-CHIN) that build the success and best practices 
derived from the original intervention. A Covid-19 session will be included as a way of helping Black women to 
maintain resilience and self-care during stressful times. The eCo-CHIN intervention is innovative and timely 
because we are using a synchronous platform preparing Black women on how to deal with Covid-19 while taking 
care of self. The primary investigator for this pilot study (Dr. Wright) is a Black Early Stage Investigator and 
former KL2 awardee. Our interdisciplinary team has the expertise and resources to deliver this Enhanced Co-
CHIN intervention.9,12,13 
The purpose of this pilot study is to determine the feasibility, acceptability, and adherence to a nurse 
and dietitian-led, health education program (eCo-CHIN) via Zoom (synchronous web-based platform) to improve 
stress and emotional regulation in Black women with hypertension. The intervention consists of four weekly 1.5-
hour synchronous (synchronous web-based) group sessions focused on blood pressure (BP) knowledge and 
calibration of home BP monitors, managing Covid-19 stress and interpersonal relationships, mindful awareness, 
sleep hygiene,  physical activity, healthy eating, and patient communication of self-care goals to their healthcare 
provider. We will employ the Cardiovascular Risk Factors, Aging and Dementia scale (CAIDE) to obtain a 
dementia risk score. Our rationale is that the adherence to healthy self-care behaviors reduces poor nutrition, 
altered sleep, sedentary behavior, psychosocial stress, and emotional dysregulation, thereby reducing negative 
impacts on the brain, since all these factors contribute to neural inflammation and increased BP.14-17 Health-
promoting self-care behaviors have the known short-term effect of enhanced cognitive function (processing 
speed, attention, and executive function) through the use of The Repeatable Neuropsychiatric Battery 
(RBANS)18which is also an innovative component of eCo-CHIN. Thirty-two middle-aged Black women (45-65 
years old) with a self-reported diagnosis of hypertension will be enrolled. The development of this group-
delivered intervention will be an iterative process, and we will use this pilot data to submit a grant for a 12-week 
intervention through the National Institutes on Aging.  
 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
Impact: Our short-term goal is to pilot test a synchronous web-based intervention, eCo-CHIN (Covid-19 stress 
management and BP self-care) to promote resilience through stress management and emotional regulation. Our 
long-term goal is to establish the efficacy of the intervention to improve stress and emotional regulation in 
persons with hypertension to prevent cognitive decline and dementia. 
 
I. 
Objectives 
The purpose of this quasi-experimental pilot study is to determine the feasibility, acceptability, and 
adherence to a nurse and dietitian-led web-based health education program (eCo-CHIN) to improve 
stress and emotional regulation in Black women with hypertension.  Thirty-two women will be 
enrolled in 3 cohorts of 6-8.. The feedback from each cohort will be incorporated, in an iterative 
fashion, to improve delivery of the intervention to the following cohort.  
 
The study aims are to:  
 
Aim 1: Determine the feasibility, acceptability, and adherence to a synchronous web-based health 
education program, eCo-CHIN, to engage in Covid-19 stress management and BP self-care for 
Black women with hypertension.    
 
H.1. We hypothesize that the intervention will be feasible, acceptable, and that participants will 
adhere to eCo-CHIN. Weekly attendance will be recorded. We will use open-ended questions after 
the 4-week sessions and elicit feedback from participants regarding feasibility and acceptability of 
eCo-CHIN. A sleep diary, self-reported physical activity, Food Frequency Questionnaire Block, and 
anthropometric data (weight, BMI, waist circumference) will be collected at baseline, 1 month, and 6 
months. 
 
Aim 2: Determine the initial efficacy of eCo-CHIN to reduce stress and improve emotional 
regulation and BP self-care (BP knowledge, resilience, mindful awareness, diet, sleep hygiene) for 
Black women with hypertension. 
 
H.2. We hypothesize that there will be an improvement in perceived stress, emotional regulation, 
and BP self-care from baseline to post-intervention. We will collect psychosocial data using the All 
of Us Cope COVID-19 survey (which includes sleep, stress , and a resilience scale), Beck Anxiety 
and Depression measures and surveys of stress,  and emotion regulation, , at baseline 1 month, 
and 6 months.  
 
Aim 3: Explore the feasibility of collecting cognitive performance data (processing speed, attention, 
and executive function) via teleconference. The Repeatable Neuropsychiatric Battery (RBANS) will 
be collected at baseline and 6 months. The CAIDE will be assessed at baseline, 1 month and 6 
months.  
 
Aim 4: Explore a preliminary economic evaluation of the cost to deliver the intervention over the 
duration of the study. Research staff will track time and resources needed for implementing the 
study including personnel, training, facilities, materials, equipment, other inputs, and required client 
inputs monthly.  
 
II. 
Background and Rationale (one paragraph each)  
As the United States population ages, a new case of Alzheimer’s disease will develop every 33 
seconds by the year 2050 (Alzheimer’s Association, 2019).19 Nearly two-thirds of Americans living 
with Alzheimer’s disease are women. Presently, 5.7 million Americans have Alzheimer’s disease; 
African Americans, here after referred to as Blacks, are twice as likely to develop Alzheimer’s 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
disease than Whites. Reducing risk factors for Alzheimer’s disease and dementia related disorders 
(ADRD) can delay its onset ; even a 5-year delay in the average onset would decrease the prevalence 
of ADRD by 45%.16 Hypertension is a significant risk factor of ADRD.20-26 The prevalence of 
hypertension among U.S. Blacks is 40%, among the highest levels in the world (American Heart 
Association).27 Moreover, the lifetime risk of having a single BP reading of 130/80 mmHg is 85.7% 
for Black women and 69.3% for White women.28  Control of hypertension is attained in only 44.4% 
of Blacks with hypertension.29 The good news is that controlling BP, even by a 10 mmHg reduction 
in SBP, reduces the risk of developing cognitive decline.30     
 
The risk factors for Blacks to develop hypertension include genetics, age, sex (postmenopausal), 
obstructive sleep apnea, diabetes, smoking, alcohol use, and discrimination stress.20-25,27,28,31-35 
Management of hypertension in Blacks is complex given the multitude of risk factors.36,37 For Black 
women, obesity38 and neurocognitive symptoms (depression and anxiety)20,39-41 are significant 
challenges that contribute to uncontrolled hypertension. A multimodal approach to manage 
hypertension that is acceptable to Black women is essential to promote healthy lifestyle behaviors.42-
44 There is an urgency to develop and test culturally informed, rigorous, and reproducible 
nonpharmacologic interventions that reduce risk factors for developing ADRD by promoting stress 
management and emotional regulation in hypertensive Black women. Few studies of such 
interventions exist.  
 
Emotion Regulation 
(PA-19-095 Emotion Regulation, Aging and Mental Disorder https://grants.nih.gov/grants/guide/pa-
files/pa-19-095.html) to promote resilience and mental health in middle-age and older adults. Older 
adults are motivated towards goals of emotional well-being. According to socioemotional selectivity 
theory, older adults tend to reduce their rates of interaction with others likely to evoke negative 
emotional experiences in favor of mental well-being.45 This results in the use of disengagement-based 
strategies (e.g., distraction, avoidance) to cope with stressful interpersonal interactions to maintain a 
sense of “peace.”45 Unfortunately, operating in this mode increases the risk of mental disorders such 
as anxiety, depression, and substance abuse.46 There are also biological sex and racial differences 
in the use of disengagement-based strategies, in that these strategies are used more by women and 
Blacks as compared to White men.6,7 Co-CHIN, is a multi-component intervention that could help to 
normalize emotion dysregulation and or strengthen emotional resilience for Black women. The 
interpersonal communication and mindfulness training component of the intervention may help these 
women avoid the use of disengagement-based strategies. 
 
Preliminary work.  
Our team established a multi-strategy 6-step process to develop the Co-CHIN intervention and ensure 
rigor and reproducibility. First, we used a business management methodology, co-creation, to gather 
a small group of stakeholders (i.e., Blacks with hypertension) to solve a complex problem, that is, 
overcoming barriers to BP self-care management and work toward an acceptable solution.9-11 The 
participants prioritized the barriers to BP management and created solutions together with our 
research team. Second, we developed probing questions and held four audio-recorded focus groups 
of 10-16 participants each. Prior to each focus group session, we shared previously identified barriers 
and solutions to BP self-management as a validity check. During the final focus group session, we 
employed a graphic recorder who drew the co-created intervention on a large poster board10 as the 
facilitator (PI Wright) verified themes with participants. The third step towards rigor and reproducibility 
was to conduct a content analysis of the audio-recorded focus groups. Our team used inductive 
coding to complete three rounds of independent analysis by three members of our research team.10 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
Transcriptions were coded using Dedoose software (SocioCultural Research Consultants, LLC, 
2017), manual notes, and field notes. The three research team members mutually agreed upon the 
final themes, categories, and codes. Fourth, we tested a prototype of the co-created intervention with 
22 hypertensive Blacks over 4 weekly group meetings, lasting 2 hours each. These sessions 
consisted of a mix of didactic teaching by a Registered Nurse or Dietitian on topics of BP self-
monitoring, interpersonal communication (e.g., family, friends), sleep hygiene, stress management, 
and healthy eating in proper proportions, and small group practice (2-3 people) of the newly learned 
skills. Seventy-two percent of the participants attended all four sessions. Fifth, using guidelines for 
developing feasibility studies, we surveyed participants to determine the acceptability of the 
intervention. On a 10-point scale, one being ‘very poor’ to ten being ‘excellent’, the participants rated 
the following: (1) satisfaction with the intervention, (2) intent to continue using the intervention, (3) 
perceived appropriateness of the intervention, and (4) the fit of the intervention within their routine 
and culture (Cronbach’s alpha 0.77). The majority of participants rated these items ≥ 8 (Table 1). 
Based on participant feedback, we increased the number of weekly sessions in the planned 
intervention from 4 to 6. A standardized manual for the delivery of the Co-CHIN intervention to middle-
aged and older Black adults with hypertension was the sixth and final step towards rigor and 
reproducibility. Because physical activity is an integral part of brain health and BP management we 
added setting goals for physical activity to each weekly module. The manual’s content covers the 
following nonpharmacologic interventions: BP information and calibration of home BP monitors, 
stress and interpersonal relationship management, sleep management, physical activity, and healthy 
eating. 
 
Our preliminary work supports our ability to successfully recruit Blacks and traditionally unheard 
groups.9,10,47 Co-CHIN was created with participants who resided in low-income neighborhoods in 
Cleveland, Ohio; this makes the Co-CHIN a good candidate for generalizability in low-income areas. 
Our targeted neighborhoods in Columbus are also low-income neighborhoods. The scientific premise 
is that the practice of health-promoting self-care behaviors reduces poor nutrition, altered sleep, 
sedentary behavior, and psychosocial stress and, thereby, reduces negative impacts on the brain, 
since all these factors contribute to neural inflammation and increased BP.14,15 Physiologically, 
increasing physical activity, managing stress, and eating a healthy diet improve BP and improve 
cognitive function by decreasing glycemic spikes, triglycerides, cholesterol, and neuroinflammation.15 
Additionally, a lack of social support and a lack of social participation are among the most powerful 
predictors of morbidity and mortality, even after controlling for relevant lifestyle (e.g., eating, smoking, 
drinking, exercise) and physical (e.g., increased serum cholesterol and BP) variables. The sharing of 
BP health information between Black women is associated with greater use of the BP information.48 
Co-CHIN also uses social interaction, support and mindfulness awareness to promote health 
behavior change.  
 
Innovation  
Through stress management and emotion regulation, our study addresses a recent National Institute 
on Aging call to action for controlling hypertension in order to prevent sequelae, including mild 
cognitive impairment, a precursor to ADRD. The proposed study is innovative because we use a 
culturally informed intervention to impact two of the greatest threats to the health and well-being of 
Black women: ADRD and hypertension. The eCo-CHIN addresses multiple lifestyle risk factors and 
harnesses the strength of social support to promote engagement in healthy self-care behaviors during 
Covid-19. Our study’s innovations include: 
 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
• 
Maximizing social interaction in a social distancing environment (Covid-19) with peers and 
health professionals (nurses and dietitians) via a synchronous web-based platform. 
 
• 
Cultural tailoring by use of culturally familiar terms in the educational materials, connecting 
mindful awareness to spiritualty, and delivery of sessions in a familiar setting (home).  
 
• 
The use RBANS via a web-based platform to explore the use of eCo-CHIN to enhance 
cognitive function (processing speed, attention, and executive function). 
 
III. 
Procedures/Approach 
Introduction. The theoretical framework for our intervention is adapted from the Information-
Motivation-Behavioral Skills model.49,50 The intervention has three components that include 
knowledge of basic information regarding an illness/disease (hypertension), motivation though 
learning in a socially supportive environment (eCo-CHIN), and behavioral skills acquired to manage 
a chronic illness through improving self-efficacy (confidence in managing hypertension) to cope with 
stress and support emotional regulation. Demographic, clinical, and lifestyle factors and 
neurocognitive factors are proposed to influence the adoption of eCo-CHIN, stress management and 
emotion regulation strategies. Cognitive function is an exploratory feasibility aim to administer testing 
via teleconference.  
 
A. Research Design  
Quasi-experiment pre/post design to test the eCo-CHIN intervention in Black women with 
hypertension.  
The intervention consists of four web-based weekly group sessions, lasing 90 minutes each that 
are delivered by a Registered Nurse (RN) and a Licensed Dietitian (LD).  
  
B. Sample 
Thirty-two Black women age 45-65 (middle-age as defined by the U.S. Census) will be enrolled 
in 3 cohorts (6-8 participants), with one new cohort beginning every 4-6 weeks. Inclusion criteria 
are English speaking, self-identification as Black/African American, diagnosis of hypertension 
(treated with medications and or lifestyle management), female sex, and access to a smart phone 
or a computer capable of connecting to the Internet (80% of Blacks have a smartphone).51 
Exclusion criteria are no access to computer with internet or Smartphone or diagnosis of resistant 
hypertension defined as blood pressure that remains above goal despite concurrent use of three 
antihypertensive agents of different classes, one of which should be a diuretic/water pill. 
 
Measurement/Instrumentation 
Table 1 displays all study measures. We have carefully chosen measures based on their 
appropriateness for this population, validity, reliability, and level of burden. The study team has 
experience with all measures. Instruments either have been used by the study team in prior work 
or have been pilot tested for the purpose of the proposed application. Most of the questionnaires 
use Likert-type scales and consist of 1-30 items averaging 10 items or less. Burden of the study 
procedures on participants was a major consideration in the selection of the study measures and 
thus, we chose measures that are short and easy to administer. Study staff will offer breaks to 
participants to use facilities as needed. In our previous experiences, it takes no longer than 90 
minutes to complete the visit. To minimize the risk of Covid-19 transmission, all data will be 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
collected remotely and will not require in-person contact. Participants will be provided with 
instructions and phone support to self-collect blood pressure and anthropometric data (weight 
and waist circumference).   
Participants will receive the links to YouTube Videos- How to take their own BP and waist 
measurements via email.  The Weight/Waist/BP Measurement document in REDCap will be used 
by the research staff to record information. 
 
 
 
 
 
 
 
TABLE 1 
MEASUREMENT 
DATA COLLECTION 
RELIABILITY/VALIDITY 
Enrollment 
 
Base   1-month 6 months 
All of Us Covid 
Cope 
Demographics, 
exposure, and 
preventative practices 
Demographics will not 
be repeated at 1 month 
and 6 months 
X 
 
 
 
Education and 
age  
Years 
X 
 
 
 
Income 
All of Us Covid Cope 
X 
 
 
 
Alcohol use 
All of Us Covid Cope 
X 
 
 
 
Smoking  
All of Us Covid Cope 
X 
 
 
 
Comorbidities  
Self-report list of 
chronic conditions 
X 
 
 
 
Anthropometric 
measures 
Waist and weight 
X 
X 
X 
 
Risk factor for 
dementia  
CAIDE 
X 
X 
X 
Sensitivity = .77, 
specificity= .63 and 
negative predictive value= 
.98. 
Co-CHIN (4 
weekly sessions) 
 
 
 
 
 
Information, 
Motivation and 
Behavioral Skills 
Attendance and weekly 
check-in for adherence 
to eCo-CHIN 
homework, sleep diary, 
and physical activity 
and blood pressure 
logs.  
 
 
X 
 
 
Outcomes  
 
 
 
 
 
Feasibility 
Investigator generated 
open-ended questions 
 
X 
 
 
Stress 
All of Us Covid Cope 
Which contains the 
perceived stress scale 
Daily Inventory of 
Stressful Events  
X 
 
 
 
X 
X 
 
 
 
 
X 
 
 
 
X 
Cronbach α = 0.83 
 
Cronbach α .71 
 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
Folkman Stress 
Questions-Investigator 
generated 
 
Emotion 
regulation 
 
 
Difficulties in Emotion 
Regulation Scale  
Beck Depression 
Inventory-II (BDI-II) 
Beck Anxiety Inventory 
(BAI) 
 
 
X 
 
X 
 
X 
 
 
 
X 
 
X 
 
X 
 
 
X 
 
X 
 
X 
 
 
Cronbach α = 0.94 
 
Cronbach α = 0.90 
 
Cronbach α = .94 
 
 
BP knowledge 
Form E WHO Covid 
X 
X 
X 
 
 
 
 
 
 
 
Diet 
The Block Food 
Frequency 
Questionnaire 
X 
X 
X 
Test-retest reliability, 
r=0.59 
 
 
 
 
 
 
 
 
 
 
 
 
Cognitive function 
Detailed in text.  
(RBANDS) 
Oral Trail Making Test 
SAGE 
X 
 
X 
test-retest or inter-rater 
reliability r=.70 
SAGE-Spearman rank 
correlation between SAGE 
and neuropsychiatric 
battery =.84 
 
 
C. Detailed study procedures 
Enrollment 
World 
Health 
Organization 
(WHO) 
Covid-19 
survey 
http://www.euro.who.int/__data/assets/pdf_file/0007/436705/COVID-19-survey-tool-and-
guidance.pdf?ua=1 ( Form E WHO Covid) adapted for persons with hypertension This survey 
takes approximately 20 minutes to complete. The survey is designed to help improve actions 
taken in response to the coronavirus pandemic (Covid-19) and to inform researcher about the 
response to similar future outbreaks. The questions cover items relating to the coronavirus about 
knowledge, attitudes, and concerns about Covid-19 and how it has impacted the participant’s 
health, including self-managing hypertension and stress. Age and Education will be self-reported 
in years. Income will be reported in US dollars, monthly. The All of Us Covid Cope form includes 
questions regarding tobacco and alcohol use. The All of Us Covid Cope survey that include the 
participant’s ID will be mailed to the participant to complete. They will received a postage paid 
envelope to return the survey to the PI at the College of Nursing. The participants’ name will not 
be on the survey. The study staff will enter survey responses in REDCap. Comorbidity data will 
be gathered using a self-report check-list of the 21 Medicare/Medicaid chronic conditions which 
includes diabetes. The CAIDE instrument is a 8 item instrument that measures cardiovascular 
risk factors that can contribute to dementia at an older age.52 The risk factors include age (>53), 
education (0-6 years), male gender, SBP (>130mmHg), total cholesterol (>200mg/dL), and 30 
minutes of physical activity for at least 30 minutes four days per week. The total score ranges 
from 0-15 with a score of 9 or above indicating intermediate to high risk profile.52  
 
eCo-CHIN 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
In our use of the Information-Motivation-Behavioral Skills model, Information will be measured by 
means of a weekly check-in for homework completeness (none, partial, complete).  Motivation 
will be measured by weekly attendance (range 1-4).   
 
Outcomes 
Primary outcome. Feasibility, whether or not the intervention is manageable for the participants 
and investigators, will be measured by recording weekly attendance.  Acceptability will be 
assessed using open-ended questions are focused on the participant’s satisfaction with the 
intervention, intent to continue using the intervention, perceived appropriateness of the 
intervention and the fit of the intervention within their routine and culture. In a future study, we will 
determine the sustainability of health behaviors. Audio tapes of recorded, using a hand held 
recorder, sessions will be reviewed to identify participant’s perception of the usefulness of eCo-
CHIN and potential challenges. We will also ask questions regarding the ease/challenges of using 
Smartphone, self-collection of data (weight, BP, waist circumference), and the frequency of use 
of the self-care supplies (pill box, BP monitor, weight scale, kick stand for phone). Adherence to 
eCo-CHIN health self-care behaviors will be assessed by reviewing homework, sleep diary, and 
physical activity and blood pressure logs.  Since we will have a wide age range (45-65) we will 
query participants’ opinions regarding the mix of ages. This will inform our larger study and 
whether we will need to stratify randomization by age in the future.  
 
Secondary outcome. Covid-19 World Health Organization contains a series of questions 
regarding self-protection, management of health, stress, resilience, and sleep.53 
”The Block FFQ is a validated measure with a food and beverage list that includes 127 
items, plus supplementary questions to allow for the adjustment of fat, protein, 
carbohydrate, sugar, and whole grain content. The questionnaire ascertains the frequency 
with which each food or beverage was usually consumed, and offered nine continuous 
responses ranging from “never” to “every day” for most foods. In addition, portion size is 
asked for each food/beverage item, with pictures provided to improve accuracy of 
estimation. The FFQs were self-administered and took approximately 30 min to complete. 
The participant will have a copy of the food portion handout to reference portion sizes. The 
analyzed food and nutrient intake data from the FFQ were then used to calculate diet 
quality based on the Healthy Eating Index 2010 (HEI) scores. The HEI is a validated diet 
quality measure that assesses how closely an individual’s dietary pattern conforms to the 
recommendations of the Dietary Guidelines for Americans.54 It includes 12 components, 
nine of which (total fruit, whole fruit, total vegetables, greens and beans, whole grains, 
dairy, total protein foods, seafood and plant proteins, fatty acids) are recommended to be 
consumed in adequate amounts, and three of which (refined grains, sodium and empty 
calories) are to be consumed in moderation.55. For all components, higher scores 
demonstrate compliance with dietary guidelines, i.e., higher scores of the “adequacy” 
components correspond to higher intake of theses dietary components, while higher 
scores on “moderation” components are indicative of lower intake of these components.55 
The standards for determining adequacy and moderation scoring standards are described 
in details elsewhere.55. Briefly, it includes: (1) identifying the group of foods under 
consideration (e.g., the total amount of foods consumed in a day), (2) linking these foods 
to relevant databases to determine the amounts of each relevant dietary constituents in 
these foods, and (3) deriving pertinent ratios to compare to relevant standards for 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
scoring.56 A total HEI score (range 0–100) is calculated from the 12 component scores 
with higher HEI scores indicative of a better diet quality and greater adherence to dietary 
guidelines.54 In the current study, both total HEI score and subcomponents were 
examined. It should be noted that national average derived from the National Health and 
Nutrition Survey also used the HEI 2010 and Block FFQ-2005 (Adams et al., pp. 4)57,58” 
2.2. Perceived Stress Scale is a 10-item Likert scale questionnaire regarding stress over the past 
month with higher scores indicating higher levels of stress (Included in the All of Use Covid 
Cope).59 We have also included two investigator generated questions based upon the work of 
Folkman and Lazarus as follows: Describe the event or situation that you have been most 
concerned about during the past month and how concerned are you about the situation?60 “We 
will use the Daily Inventory of Stressful Events61 Stress is a multidimensional construct with 
different areas of stress potentially having differential relationships with short-term and long-term 
outcomes. The Daily Inventory of Stressful Events (DISE) is a semi-structured survey in which 
participants report whether any of a series of stressful events had occurred within the past 24 
hours. This end-of-day measure consists of a brief set of stem and conditional questions that can 
be can be administered via smartphones. An example stem question is “Did you have an 
argument or disagreement with anyone in the past 24 hours?” An example follow-up questions is 
“How stressful was this?” “How much control did you have over the situation?” This instrument 
yields several variables for each reported stressor including: (a) content classification of the 
stressor (e.g., work overload, argument over housework, traffic problem); (b) subjective severity 
of stressors; (c) primary appraisals (i.e., areas of life that were at risk because of the stressor); 
and (d) perceived control of the situation.”61 (cite)Participants will be administered the Difficulties 
in Emotion Regulation Scale  to examine changes in degree of self-reported emotion 
dysregulation following mind-body interventions.62This measure has 18 items, each measured on 
a 5-point rating scale. One total score will 62be calculated by summing the individual item 
responses. Higher scores represent greater perceived difficulties in emotion regulation 
capabilities. To further examine the components of emotion regulation, will be evaluate by 
functional outcomes major domains of cognitive and affective functioning (e.g., anxiety and 
depression), with standardized, norm-referenced measurements (allowing quantification of 
whether there has been a significant differences of: (a) neuropsychological functioning; (b) 
emotional functioning; (c) and quality of life. For example, for every 10mm Hg increase in systolic 
BP (also known as the “ top number”) there was an increase in risk for poor cognitive function of 
(9%).21 We will use the following questionnaires to characterize mood and quality of life variables: 
(1) Beck Depression Inventory-II (BDI-II)63: The BDI-II24 is a 21-item, self-report mood measure 
of depressive symptomatology; (2) Beck Anxiety Inventory (BAI)64:  The BAI25 is a 21-item 
measure of primarily physiological symptoms of anxiety; and (3) Quality of Life Inventory is a 32-
item questionnaire where participants rate the importance of, and satisfaction with, 16 life 
domains, such as health, community, and friends.65  
 
Behavioral Skills will be assessed by the Form E COVID-19 Coachman questionnaire that has 8 
questions regarding self-efficacy to manage hypertension. Responses range from 1 (not confident 
at all) to 10 (totally confident) for each question. Higher scores are indicative of greater self-
efficacy. We will ask investigator generated questions regarding their medication adherence as 
follows: Have you missed taking your blood pressure mediation over the past 4 weeks? If yes, 
how many days did you miss taking your medication? Was cost of the medication a barrier to 
taking your blood pressure medication?    

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
 
Exploratory outcome. Each participant will be administered a brief neuropsychological battery of 
tests taking approximately 1 hour to administer and consisting of standardized clinical instruments 
designed to assess a broad range of cognitive skills and emotional functioning. The Repeatable 
Battery for the Assessment of Neuropsychological Status (RBANS) is a widely used screening 
instrument in neuropsychological assessment. The RBANS consists of 12 subtests that assess 
cognitive domains such as Immediate and Delayed Memory, Language, Attention, and 
Visuospatial/Construction and takes about 30 minutes to administer. Different aspects of 
processing speed, complex attention, and executive functioning will be measured with the Trail 
Making Test Part A and B, a measure of processing speed, mental flexibility, and set-shifting; the 
COWAT, a measure of phonemic verbal fluency; and the Stroop Color Word Test. The exam will 
be tailored to deliver via teleconference.18 To facilitate assessment virtually, we are removing the 
complex figure drawing and coding tasks. They are being replaced with the Self-Administered 
Gerocognitive Examination (SAGE)66 that includes a clock drawing and the oral trail making 
test.67,68 SAGE covers cognitive domains of orientation, language, memory, executive function, 
calculations, abstraction, and visuospatial abilities. 
 
We established a BUSINESS ASSOCIATE AGREEMENT with BrainTest, INC SEZC to obtain 
access to the Self-Administered Gerocognitive Screen online.  Participants shall only be able to 
access their BrainTest on submission of a unique Identification number to be created by OSU 
(the “ID”). BrainTest shall not accept any personally identifiable information from any of the 
Participants. BrainTest will provide the following:  
1. BrainTest shall provide OSU with a unique internet URL where only the Participants shall have 
access to take the BrainTests from OSU’s or the Participants’ own touch screen tablets or touch 
screen computers.  
2. BrainTest shall develop a web based portal for the recording of all Participants BrainTests 
scores (the “Portal”). The Portal shall be password protected and shall be for the sole use of OSU. 
OSU shall be able to download all data in the Portal in .xls format, at any time prior to the 
termination of this Agreement.  
3. BrainTest shall use its Core Scoring Lab to score all the BrainTests submitted by the 
Participants. All the scoring of the Participants’ BrainTests shall be completed within 48 hours of 
the BrainTests being submitted by the Participants. All Participants’ scores shall be uploaded to 
the Portal by BrainTest using each Participants’ ID as the identifier. 
 
Advisory Board  
 
We will rely on the Advisory Board to assist us with accessing the community by making 
introductions of study staff to key community leaders and members and identifying community 
assets (e.g., resources, organizations) to support the project. The Advisory Board will have a role 
in tailoring of the intervention and recommendations to promote sustainability of the project, 
dissemination, and problem-solving with the research team.  The Community Advisory Board will 
meet monthly via Zoom, more if needed. We will work closely with the Community Advisory Board 
to ensure that our de-identified summary of findings are fair and accurate and provide input on 
how best to disseminate the results back to the community. The Study PI is in charge of the 
meetings and no participant information will not be shared with the Advisory Board. 
 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
Detailed study procedures 
 
Recruitment. Participant recruitment will be through advertisement at local primary care clinics, 
Family Medicine’s Research Network, ResearchMatch, churches, and community organizations 
with flyers and online social networks (e.g. websites, Facebook, LinkedIN). Participants may self-
refer or be referred by a provider. All recruitment efforts will begin once approval from the IRB is 
received. The primary recruitment in the proposed study is ResearchMatch (attached Guidance 
and Message Template for IRB Submission for Use of ResearchMatch.org). I am requesting the 
use of ResearchMatch.org for participant recruitment on this protocol. In addition, we will use 
other social media because as many as 68% of adults in the US use Facebook regularly. 
Permission from the appropriate party (e.g, moderator of Facebook page) will be gained prior to 
the posting of any recruitment materials. Once approval is received, the study team will post a 
flyer (see attachment) in each respective online location. The flyer contains general information 
about the study including university affiliation, time commitment, confidentiality, compensation 
availability, and contact information for eligibility and screening procedures. We will also provide 
recruitment information to the Women’s Place at The Ohio State University. We will also use 
snowball recruiting where participants inform their contacts about the study to enable their 
contacts to potentially be enrolled in the study. 
 
Participant ID: Participants will be assigned a REDCap auto-generated ID number which will 
identify them at all data collection points. 
 
Retention Plans.  
In studies longitudinal studies, a threat to internal validity is selection bias or selection threat. 
This can occur due to study drop out. To decrease the risk of participants dropping out of the 
study, we have employed several strategies. 
 
1. Data collection and intervention delivery option for weekends and evenings.   
2. Reminder calls to participants for data collection and sessions.  
3. Participants will be remunerated for their assessment time according to the following 
schedule: 
After completion of the COVID ALL OF US COPE survey at baseline, you will receive a $10.00 
Amazon gift card.  
 
 
 
After completion of the 1-month data collection, participants will receive items donated by the  
Alcohol Drug and Mental Health (ADAMH) of Franklin County system that includes a resource 
directory, grocery bag that includes an ink pen, stress ball, bag clip, and hand sanitizer, 
Additionally, The Ohio State University James Cancer Center has donated a scarf, insulated 
cup, and lip gloss.  
 
After completion of the study, at 6 months, the participant will have the option of either receiving 
a $75.00 Amazon gift card or retain their self-care monitoring equipment (Home BP monitor and 
weight scale). If the participant selects the Amazon card, then we will provide them with a 
postage paid package to return the self-care equipment.  
 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
After completion of the COVID ALL OF US COPE survey at 6 months, you will receive a $10.00 
Amazon gift card. 
 
Participants will also waist tape measurer, pill box, and kick stand for their smartphone.  
 
The reason for any participant’s discontinuation and the date of withdrawal will be recorded in 
the participant’s case file. The participant’s case file, which will be completed up to the point of 
withdrawal, will be retained for five years. The study report will include reasons for participants’ 
withdrawals as well as details relevant to the withdrawal. Each participant will be encouraged to 
complete the full course of the intervention assignment and study assessments.  However, it is 
made clear to participants that they may discontinue study participation at any time for any 
reason. The reason for early withdrawal must be documented in the participant’s case file and in 
the participant tracking document.     
 
Handling of withdrawal. If a participant is withdrawn from participation in the study at any time at 
his or her request, or at the IRB or Principal Investigator’s discretion, the reason(s) for 
discontinuation shall be documented thoroughly in the source documents and participant’s case 
file. All participants who are withdrawn prematurely will undergo the procedures outlined in the 
discharge visit. 
 
Procedures overview. Using an IRB approved script, we will recruit, screen and enroll 
participants until we have 32 qualified participants. An initial visit will be scheduled to obtain 
baseline survey data (approximately 90 minutes), and complete the baseline cognitive function 
testing (60 minutes). Per participant’s preference, the survey data and cognitive function testing 
may be done on two separate days.  
Procedures.  
 
Informed consent. Interested participants will be given access to the self-initiating process to 
provide information (email and phone) and to contact a member of the study team with questions, 
prior to consent. This will also serve as pre-screening to review inclusion/exclusion criteria for the 
eligibility of the participants. The eligible participants will be consented using a REDCap-based 
electronic consent form. The consent form has been developed in REDCap, a secure, web-based, 
HIPAA-compliant, data collection platform with a user management system allowing project 
owners to grant and control varying levels of access to data collection instruments or data (e.g. 
read only, de-identified-only data views).  Self-initiating process can be done on personal portable 
electronic devices using posted QR codes or web-links on study fliers, social media, or websites.  
 
The steps to consenting are as follows: 
1. 
Potential participants would access the Verbal Script for Obtaining Informed Consent The 
Ohio State University Consent to Participate in Research via REDCap link provided on the 
study recruitment materials. 
 
2. 
The consent link will have a prescreen feature. 
a. 
 If a person says no to one of the inclusion criteria (black/African American, female, 
diagnosis of hypertension, age 45-65) questions, they would be thanked and told that they 
do not qualify.  

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
b. 
This would also be yes for any of the exclusion criteria (no access to computer with 
internet or Smartphone, diagnosis of resistant hypertension defined as blood pressure that 
remains above goal despite concurrent use of three antihypertensive agents of different 
classes, one of which should be a diuretic/water pill). 
c. 
If the person meets the eligibility criteria, then the verbal script for obtaining 
informed consent will appear.  
 
3. 
At the end of the consent form, the person would click a checkbox to be enrolled in the 
study.  
 
 
If the person says no, then they will be thanked for their time.  
  
 
4. 
If the person checks yes, another box would open to request their contact information 
(phone, email, mailing address) and query as to whether or not they want documentation 
linking them to the research.  
 
5. 
We will contact the participant to confirm eligibility for the study, answer any questions 
they may have about the consent form, verify verbal consent (logged in REDCap), and 
schedule the first study visit.  We will mail a copy of the consent form to the participant for 
their records.  
 
Baseline survey data will be collected as listed in Table 1. Data will be collected using a private 
room via phone or Zoom secure video conference. The participant can enter by invitation only. If 
the participant does not have access to a touch screen tablet or computer, they may be able to 
borrow one of our two IPads from the College of Nursing. This would be mailed to the participant 
with return postage paid.  
.  
1. 
Meetings will require a password by default. These passwords will be embedded in the 
meeting URL (link) by default. 
2. 
Annotations will not be available to participants by default. 
3. 
The ability to join a meeting before the host or alternate host joins will be disabled by default. 
4. 
Participants will not be able to change their names by default. 
5. 
The questions to surveys will be read to the participant and answers recorded on survey 
forms and entered into REDCap under the participant’s study ID number. Response cards 
will be given to participants to follow along with the interviewer.  
In the future, we may have similar research studies. The consent form will also include the 
opportunity for participants to partner with us for potential future studies that are related to 
hypertension and health in Black and African Americans. The scope of the request for the 
participant’s contact information will be access to the following by the study team/PI: 
The contact information will not be provided to other investigators for similar research projects 
without further informed consent (e.g., recruitment registry).  
a. First and last name. 
b. Address 
c. Phone number (cell/home) 

I R B Pr ot o c ol N u m b er: 
2 0 2 0 B 0 1 8 2  
I R B A p pr o v al d at e:  
0 6 -2 8 -2 0 2 0  
V er si o n:  
1 1 -1 3 -2 0 2 0   
2- 2 3 -2 0 2 1  
5- 2 6 -2 0 2 1   
1 0 -0 1 -2 0 2 1  
 
d.  E m ail  
T h e c o n s e nt f or m will al s o pr o vi d e a n o p p ort u nit y t o p arti ci p at e i n f ut ur e r e s e ar c h.  W e will o bt ai n 
t h e p arti ci p a nt’ s p er mi s si o n t o c o nt a ct t h e m i n t h e f ut ur e ( y e s/ n o). T h e y ar e n ot r e q uir e d or 
o bli g at e d t o pr o vi d e t h eir c o nt a ct i nf or m ati o n f or f ut ur e r e s e ar c h o p p ort u niti e s.  
T h e c o nt a ct i nf or m ati o n of p arti ci p a nt s, w h o a gr e e t o b e c o nt a ct e d i n t h e f ut ur e, will b e st or e d i n 
t h e s e c ur e R: dri v e at t h e C oll e g e of N ur si n g.  
I nt er v e nti o n Pr ot o c ol. T h e e C o -C hi n a n d gr o u p s e s si o n s will b e r e c or d e d, u si n g a h a n d h el d 
r e c or d er, t o m o nit or fi d elit y a n d t o r etr ai n t h e R N, L D, a n d A C gr o u p l e a d er a s n e e d e d. B ef or e 
e a c h e C o -C HI N s e s si o n, t h e R A will c o n d u ct a c h e c k -i n t o m e a s ur e B P a n d r e vi e w t h e sl e e p a n d 
p h y si c al a cti vit y l o g s ( s e e b el o w). At t h e e n d of e a c h s e s si o n, t h e p arti ci p a nt s will i d e ntif y o n e 
g o al t h at i s s p e cifi c, m e a s ur a bl e, a c c e pt a bl e , r el e v a nt, a n d ti m e-b o u n d ( S M A R T ). T h e y  will al s o 
r e c ei v e,  vi a  U. S.  m ail,  t h e  D ail y  F o o d  a n d  P h y si c al  A cti vit y  Di ar y  a n d  t h e  N ati o n al  Sl e e p  
F o u n d ati o n Sl e e p Di ar y t o c o m pl et e a s h o m e w or k. T h e di ari e s will b e c oll e ct e d w e e kl y a s a 
m e a s ur e of tr e at m e nt e n a ct m e nt.  
 
I nt era cti v e P o w er P oi nt pr e s e nt ati o n s of e d u c ati o n al c o nt e nt will b e d eli v er e d vi a Z o o m.  
 
P arti ci p a nt pr ot e cti o n a n d Z o o m . U si n g t h e O nl y a ut h e nti c at e d  u s er s c a n j oi n s etti n g will pr e v e nt 
g u e st s w h o d o n ot h a v e a n O hi o St at e Z o o m a c c o u nt fr o m e nt eri n g t h e s e s si o n . Si n c e t h e m e eti n g 
i n cl u d e s n o n-u ni v er sit y p arti ci p a nt s,  t h e PI will u s e t h e f oll o wi n g str at e gi e s t o c o ntr ol w h o c a n 
att e n d.   
 
P arti ci p a nt s o nl y wit h a c c e s s c a n j oi n  
 
T ur n off t h e o pti o n t o J oi n b ef or e H o st  
 
T ur n o n t h e W aiti n g R o o m  
 
M e eti n g will b e p a s s w or d pr ot e ct e d  
 
P arti ci p a nt s will b e i nf or m e d t h at t h e Z o o m gr o u p s e s si o n s will b e r e c or d e d  u si n g a h a n d h el d 
r e c or d er. A d diti o n all y,  w e will o bt ai n t h e p arti ci p a nt’ s p er mi s si o n i n a d v a n c e. P arti ci p a nt s will b e 
e n c o ur a g e d t o u s e t h eir c a m er a t o f a cilit at e i nt er a cti o n. H o w e v er, p arti ci p a nt s  will b e a gi v e n t h e 
c h oi c e t o  t ur n off t h eir c a m er a a n d mi cr o p h o n e a n d u s e t h e Z o o m C h at if t h e y pr ef e r.  P arti ci p a nt s 
m a y u s e a n a v at ar i m a g e of t h e m s el v e s i n t h e Z o o m r o o m. E a c h c o h ort will c h o s e a p s e u d o n y m 
f or t h eir c o h ort. P arti ci p a nt s m a y s h ar e t h eir c o nt a ct i nf or m ati o n, n ot r e q uir e d, if t h e y w o ul d li k e 
t o s u p p ort o n e a n ot h er i n t h eir h e alt h g o al s. T h e st u d y st aff will n ot pr o vi d e p arti ci p a nt s wit h e a c h 
ot h er’ s’ c o nt a ct i nf or m ati o n . T h e f o ur w e e kl y gr o u p cl a s s e s will b e a u di o r e c or d e d u si n g a h a n d 
h el d r e c or d er. T h e r e c or d e d s e s si o n s will b e c o n v ert e d a n d st or e d el e ctr o ni c all y i n a s e c ur e 
s y st e m c all e d R E D C a p. T h e a u di o r e c or di n g of t h e gr o u p cl a s s e s will b e t h e n d e str o y e d.   
 
Pr e s e nt e d at t h e N ati o n al Mi n orit y Q u alit y F or u m  A pril 2 0 2 0, t h e C or o n a vir u s A n xi et y W or k b o o k 
(htt p s://t h e w ell n e s s s o ci et y. or g/fr e e -c or o n a vir u s -a n xi et y -w or k b o o k/ ) u s e s  e vi d e n c e b a s e d str e s s 
r e d u cti o n t e c h ni q u e s t o pr o m ot e m e nt al w ell-b ei n g d uri n g a p a n d e mi c. T h e f oll o wi n g t o pi c s ar e 
li st e d  i n  t h e w or k b o o k:  Pl a n ni n g  Y o ur  I nf or m ati o n  Di et; M y  S p h er e s  of I nfl u e n c e W or k s h e et ; 
Pr a cti c al  Wi s d o m  f or  T ol er ati n g  U n c ert ai nt y ; R e d u ci n g  A n xi et y  Wit h  T h o u g ht  C h all e n gi n g ; 
R e d u ci n g A n xi et y T hr o u g h Di str a cti o n A cti viti e s ; St arti n g a Pl a n ni n g Pr a cti c e ; St arti n g a D ail y 
Gr atit u d e  Pr a cti c e ; St arti n g  a  D ail y  Br e at hi n g  Pr a cti c e ; I m pr o vi n g  t h e  Q u alit y  of  Y o ur  S o ci al  
C o n n e cti o n s ; D e v el o pi n g  a  R e g ul ar  E x er ci s e  R o uti n e ;  a n d Cr e ati n g  Y o ur  Str e s s -R e sili e n c e 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
Action Plan. Each session will begin with a 15-30 minute check in on what went well, challenges, 
and Coronavirus Anxiety workbook. The Coronavirus Anxiety Workbook topics are 
complementary and the sessions will tie together the themes of comprehensive stress and 
emotional management through blood pressure knowledge/self-monitoring, diet, interpersonal 
communication skills building, and sleep hygiene.  
 
Session 1 (LD Dietitian Interventionist). “DASHing Through Life provide an overview of the DASH 
eating plan and why it is important for African Americans. The goal is to help these women to 
make daily life changes. The content was developed by a Registered Dietitian Nutritionist using 
evidence based materials from Academy of Nutritional dietetics and the American Heart 
Association. Critical Thinking Strategies were used to engage participants to think about barriers 
and solutions to the incorporation of the Coronavirus Anxiety Workbook skills to reduce emotional 
eating. Part of the Critical Thinking Strategies is goal setting and review. We will review 
modifications to healthy eating of traditional “soul food/southern” meals. At the end of the session, 
participants can use Critical Thinking Strategies to have their food diary reviewed by the dietitian 
and the group. For homework, participants will complete Coronavirus Anxiety Workbook on 
Developing a Regular Exercise Routine; and Creating Your Stress-Resilience Action Plan. 
Session 2 (RN Interventionist). The session will begin with a review of foods that promote stress 
reduction followed by monitoring Your Blood Pressure covers diagnosis, causes, risk factors, 
symptoms, interventions, and how to self-monitor BP. This includes an interactive didactic lecture 
and slide presentation and distribution of personal arm-automatic BP monitors. Research 
assistants will work with participants to demonstrate use of the home BP monitor. The participants 
will watch a video and practice measuring their BP. Reviewing stress related factors that may 
increase blood pressure. Building resilience and managing emotions in stressful times. 
Participants will receive the Coronavirus Anxiety Workbook-A tool to help build resilience during 
difficult times. For homework, participants will identify strategies to reduce information overload 
and complete the Spheres of Influence worksheet.  
 
 
Session 3 (RN Interventionist). The session will begin with a review of blood pressure monitoring 
followed by stress and emotion regulation management through interpersonal communication 
skills training. We cover effective communication (verbal and nonverbal), thinking, listening, and 
speaking. Participants learn about communication and the effects of stressful communication on 
the body’s physiological responses. They are encouraged to talk about their positive and negative 
experiences communicating with family and friends in the context of the Black culture. Participants 
learn problem solving skills to address communication breakdown and practice what they have 
learned. For homework, review Improving the Quality of Your Social Connections from the 
Coronavirus Anxiety workbook; Practical Wisdom for Tolerating Uncertainty; and Reducing 
Anxiety With Thought Challenging. Participants will also complete a sleep diary.  
 
Session 4. (RN Interventionist). Sleep lifestyle. The session will begin with emotion regulation 
review followed by the RN review of  barriers and facilitators to good sleep, sleep management 
practices, and relaxation before bedtime. This will include a review of foods that help with sleep. 
Participants practice a 10-minute mindfulness body scan. Identification of preferred physical 
activities is introduced by the RN as a tool to improve sleep. Throughout the session, the RN 
reinforces collaboration with their health providers to seek treatment for sleep problems. The 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
group will review the sleep diaries that they completed the previous week and share strategies. 
For homework, participants will review Reducing Anxiety Through Distraction Activities and 
Starting a Planning Practice and Starting a Daily Gratitude Practice from the Coronavirus Anxiety 
workbook. They will be contacted by study staff via phone to review their final homework 
assignment.  
 
The sessions will be recorded using Zoom so that those who miss a session can access and 
listen to the lesson.  
 
Using an investigator-generated form, trained research staff will provide a self-care coaching call 
to participants (approximately 10-20 minutes) to review questions and provide ongoing support of 
self-care. The calls will be made twice a month for four months. The data will be entered into the 
REDCap Coaching call form.  
 
Field Notes 
 
Research staff may describe their thoughts about factors they observed that contributed to the 
quality of each encounter by writing a brief field note. The field notes will be documented in 
REDCap. A descriptive qualitative analysis will be conducted to categorize themes. 
 
Incidental findings. Blood pressure. The following guidelines will be used to triage unanticipated 
blood pressure findings; if average systolic BP is >150 or diastolic BP is >110, we will instruct the 
participant to follow up with health provider or an urgent care center if the participant does not 
have a health provider. 
 
Data Validity/Integrity   
It is the responsibility of the Principal Investigator to ensure that all team members handle data 
and related documentation appropriately. All participant information, including source 
documents must be reviewed by the PI and clinical team and entered into the REDCap 
database.  There will be ongoing processing of data and quality checks by the study statistician 
and or PI.  
 
 
Recruitment:  
Participant recruitment will be tracked and reviewed in the weekly meetings of the 
research team. In order to maintain confidentiality, the list, which includes the names of 
all potential participants, will be kept separately from the documentation and tracking 
spreadsheet in the College of Nursing R: Drive (duo authentication).  Tracking will be 
carried out to determine which and how many individuals are interested in study 
participation, are eligible for study participation, enroll in the study, and complete the first 
assessments.  Enrolled participants will be given code numbers and their study 
participation will continue to be tracked via spreadsheet in the College or Nursing 
R:Drive using and Excel spreadsheet. This will include documenting the occurrence and 
date of completion of data collection at each time point and their participation in the 
intervention.   
 
Quality Assurance:  

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
To minimize data-entry error and data-management miscoding, data will be entered into 
REDCap directly and we will have a paper forms as a back-up. If the data has to be 
transcribed into REDcap from a paper form, we will do a double data entry process.  PI 
Wright and or designated study staff will review the data collected and all related 
documentations weekly.   
 
Data Storage: 
Consent forms will be stored in REDCap. Participant lists (ID number and demographic 
information) will be stored in the College of Nursing R:Drive on a spread sheet.  The PI 
and designated study staff will have access to data.  All participant data collected via 
REDCap will be labeled only with a code number. These coded data will be kept 
separate from the master list that links participants to their consent forms. Only the PI 
and designated research study staff will have access to the data.   
 
This study will utilize REDCap (Research Electronic Data Capture), a software toolset 
and workflow methodology for electronic collection and management of clinical and 
research data, to collect and store data. The OSU Center for Clinical and Translational 
Science (CCTS) Research Informatics Services will be used as a central location for 
data processing and management. REDCap provides a secure, web-based application 
that provides an intuitive data manipulation interface, custom reporting capabilities, audit 
trail functionality, real-time data monitoring/querying of participant records, and 
variations of data exporting/importing. REDCap is hosted by OSUWMC IT in the 
Ackerman Datacenter (640 Ackerman Road; Room 345) 
 
REDCap instance is located on internal OSUWMC network. Remote access to this 
network can be obtained over an encrypted VPN tunnel (AnyConnect) This VPN uses 
Protocol: DTLS and Cipher: RSA_AES_128_SHA1. Background checks are performed 
on all staff that are on the network or obtaining VPN access. 
 
Termination for Significant Risk: 
Although the study is deemed low risk and adverse events are not anticipated, diligent 
monitoring will occur as specified above under Adverse Events Protocols. A participant 
that expresses concern about his or her participation or reports distress associated with 
receiving the eCo-CHIN intervention may be asked to discontinue participation in the study 
if there is concern about participant safety and wellbeing or about the safety and wellbeing 
of others. Likewise, if one of the research assistants, interventionists or supervising 
members of the Research Team expresses a concern about a participant’s safety or 
wellbeing, the Office of Responsible Research Practices Adverse Events Reporting 
process will be used and it is possible that the participant could be asked to discontinue 
participation if there were concern about his or her, or others, safety and wellbeing. 
 
D. Internal Validity 
 
The quasi-experimental design is a limitation but it is an acceptable design for a feasibility study.  
We will repeat measures of stress and emotion regulation over three time points (baseline, 1 
month, 6 months) to reduce regression to the mean as an internal validity threat.  
 
E. Data Analysis 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
We will use descriptive statistics to examine variable distribution, check for outliers and 
summarize sample characteristics and outcome measures at each time point.  For Aim 1, we will 
use descriptive statistics to quantify the rates of recruitment, attendance, and attrition for 
feasibility. Using a semi-structured list of open-ended questions, we will elicit participant feedback 
regarding the acceptability of the intervention. The Consensual Qualitative Research Method 
(CQR) 69 will be used to analyze qualitative data. The responses to open-ended questions will be 
transcribed. The transcripts will be reviewed by three members of the research team to determine 
core domains (themes).  
 
“The preliminary lists will be presented to on another, providing examples  
from the transcripts. After deliberation, a list of the domains will be agreed  
upon. Each team member will then review the data and verify the quality  
of the consensually chosen domains, and subsequently met again to  
discuss and arrive at a consensus on a final list of domains. Categories  
will be labeled based on the frequency of occurrence of themes in the  
data (Nguyen et al., 2013, pp. 3-5)”  
 
For Aim 2, we will first use descriptive statistics and trend plots to examine the outcomes (stress 
and emotional regulation) over time (baseline, 1-month, and 6-months). Next, Paired T-tests will 
be performed to examine the change of each outcome at 1-month (vs. baseline) and at 6-months 
(vs. baseline). Sample size from this pilot study will not have sufficient power to detect small-to-
medium effect sizes for within-group difference (e.g., 54% power to detect a Cohen’d of 0.5 with 
a two-sided significance level of 0.05). Therefore, we will not rely on statistical significance. 
Instead, we will estimate point estimates, 95% confidence intervals and effect sizes. These 
estimates along with clinical significance will guide our results interpretation and inform the 
sample size determination for a future NIH funding mechanism. For Aim 3, changes in RBANDS 
measure will be analyzed using the same approach for Aim 2 (baseline and 6 months). For Aim 
4, Co-I Chyongchiou J. Lin, Health Economist, will use descriptive statistics, trends, and plots to 
evaluate allocations of resources and estimate costs of the intervention at various stages. 
 
F. Project Timeline  
The development of this group-delivered intervention will be an iterative process, and we will use 
this pilot data to submit an external grant for a 12-week intervention through the National Institutes 
on Aging in 12-18 months.  
 
 
 
Table 2. Project timeline.  
Activity 
1-2 
months 
3-4 
months 
 
5-6 
months 
7-8 
months 
9-10  
months 
11-12 
months 
IRB application 
X 
 
 
 
 
 
 
Recruitment  
 
X 
 
X 
 
 
 
Data collection (baseline, 1-month, 6-
months) 
 
X 
 
X 
X 
X 
 
Delivery of Intervention  
 
X 
 
X 
X 
 
 
Preliminary data analysis of baseline data 
for an NIH grant in February 2022 
 
 
 
X 
X 
X 
X 
Final data analysis 
 
 
 
 
 
X 
X 
Dissemination  
 
 
 
 
 
 
X 
 

IRB Protocol Number: 
2020B0182 
IRB Approval date:  
06-28-2020 
Version:  
11-13-2020  
2-23-2021 
5-26-2021  
10-01-2021 
 
 
 
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