Self-Care and Blood Pressure for Women Caregivers of Black and African-Americans With Alzheimer's Disease or Other Memory Problems *
Phase: NA
Conditions: Hypertension, Stress, Psychological
Sponsor: Ohio State University

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
04-13-2023 
 
 
 
INTRODUCTION 
 
Due to health and wealth disparities, no demographic group is more at risk 
than African American women for the double jeopardy of stress from caregiving 
for persons living with dementia (PLWD) and stress associated with hypertension 
(HTN). This double jeopardy puts those they care for in jeopardy as well: Reduced 
quality of life and longevity, disability, cognitive decline, and stroke associated with 
HTN1 impede caregiving activities and resultant health and well-being for persons living 
with Alzheimer’s disease and related dementias (ADRD). Although successful multi-
component interventions have addressed ADRD caregiver stress (REACH II) and the 
Savvy Caregiver program, to our knowledge there are no interventions that target 
the complexity of chronic caregiving stress and HTN self-care for African 
American women caregivers of persons living with ADRD.   
This project will test two interventions for their effectiveness in improving 
outcomes for the target group: Mindfulness in Motion (MIM) and the Dietary Approaches 
to Stop Hypertension (DASH). Dr. Maryanna Klatt developed MIM, which includes 
mindful awareness and movement from a seated position, breathing exercises, healthy 
sleep, and guided mindfulness meditation.2 The DASH component will be tailored for 
Black Americans. It uses a critical thinking approach that involves problem solving, 
participant-centered goal setting, health coaching, reflection, and development of self-
efficacy (confidence) to promote physical activity and healthy eating. Solid empirical 
evidence demonstrates its effectiveness in reducing blood pressure among mixed-race 
samples.3-6 
Our long-term goal is to develop effective interventions to reduce cardiovascular 
health disparities and improve health outcomes among African American women. Given 
this gap in knowledge (i.e., interventions targeting caregiving stress and hypertension 
self-care), our Stage I pilot study focuses on a) caregiver stress and b) self-care 
for hypertension, the most prevalent chronic condition among African American 
women caregivers of PLWD. We know lifestyle changes are effective in managing 
HTN, but they will not make a difference in controlling hypertension if individuals do not 
engage in these health behaviors. Unfortunately, African American women are less 
likely to engage in self-care (such as diet and exercise behaviors) if they believe their 
hypertension is caused by stress.7 Indeed, our past research demonstrates that 
stressful interpersonal communication problems, blood pressure knowledge deficits, 
and complex diet information all interfered with older African American women’s blood 
pressure self-care.8,9 Thus, we investigate the hypothesis that by addressing stress 
reactivity/stress resilience as the underlying mechanism to facilitate behavioral 
change, the intervention will be successful in enhancing HTN self-care.  
A small-scale, Stage I, three-group randomized controlled trial (RCT) will 
investigate the feasibility of MIM plus DASH to improve blood pressure self-care in 
African American caregivers, as compared to MIM only or DASH only. Each intervention 
will be delivered in eight weekly 1-hour group sessions via telehealth.  

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
04-13-2023 
 
 
 
To our knowledge, this is the first study that systematically a) examines impact 
on self-care behaviors and b) employs one of the Science of Behavioral Change key 
mechanisms underlying successful change in health behaviors-stress 
reactivity/stress resilience among a large, underrepresented demographic group. PI 
Wright will recruit 90 women with hypertension who are caring for persons living with 
ADRD, 30 per group (MIM DASH, MIM only, or DASH only). We will collect data at 
baseline, 3-months, and 6-months. The interprofessional team pursuing this project has 
worked together for 3 years. Our aims will be as follows:  
 
AIM 1.  Determine the feasibility of MIM DASH, MIM, and DASH for African American 
women caregivers of family/friends living with dementia. Hypothesis: African American 
women caregivers with hypertension will participate in the MIM DASH as well as the 
active control groups (MIM or DASH). 
 
Aim 2.  Examine pilot efficacy of the MIM DASH intervention to improve stress and self-
care as compared to active control groups (MIM or DASH). Hypothesis: Stress will be 
reduced and self-care will be improved in the MIM DASH group as compared to active 
control groups (MIM or DASH). 
 
AIM 3. Examine the pilot efficacy of the combination of MIM plus DASH for 
improvement of systolic blood pressure (SBP) as compared to active control groups 
(MIM or DASH). Hypothesis: Relative to baseline assessment, the MIM DASH group will 
exhibit lower SBP at 3 and 6 months as compared to active control groups (MIM or 
DASH). 
 
Impact: Our short-term goal is to complete the project in years 1-4 of the 
ADMFP. After preliminary findings, our intermediate goal is to launch a larger scale 
project to train community health workers to disseminate this intervention. The larger 
trial will also include wearable sensory technology to assess emotional responses to 
stressors and gather ecological momentary assessment data. PI Wright’s primary 
mentor, Dr. Karen Rose, has experience and will guide me in the use of this 
technology. The curriculum and training for the MIM DASH intervention can be 
disseminated to all 88 counties in Ohio, including OSU employees, through an existing 
mechanism—OSU Extension. In addition, PI Wright has established a relationship with 
the Columbus African American Alzheimer’s and Wellness Association and Central 
Ohio Area Agency on Aging. These relationships with key community partners will allow 
us to disseminate MIM DASH on a national scale in the future. Our long-term goal is to 
establish the efficacy of the intervention to improve cardiovascular health outcomes and 
reduce cost for African American women.   
 
BACKGROUND AND RATIONALE 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
04-13-2023 
 
 
 
African American women are disproportionately burdened with informal 
caregiving. In 2019, informal caregivers provided 18.6 billion hours of unpaid care to 
people living with Alzheimer’s disease and related dementias, with African American 
women providing 60% of this care.10,11 Although African American women generally 
endorse positive feelings about caregiving and express cultural justifications for 
providing care,11-15 they endure the adverse effects of chronic caregiver stress—
increased cortisol16,17 and HTN.18 Indeed, HTN is the leading cause of cardiovascular 
disease (CVD) among African American women, affecting 56.7% of the population  with 
CVD.19 Yet, to our knowledge no behavioral intervention studies have addressed 
the dynamic interplay of chronic caregiving stress with HTN self-care in African 
American women. Our intervention thus has potential to serve a vast population 
underrepresented in many scientific studies   
Current caregiver interventions are not as effective for African Americans 
as compared to other populations. Three key studies: Resources for Enhancing 
Alzheimer’s Caregiver Health (REACH II),20 Savvy Caregiver,21 and Enhanced Physical 
Activity Intervention had a sample sizes of African Americans sufficient to draw 
significant conclusions.22 All three demonstrated lower success of the intervention 
among African Americans.23 None of these studies included mindfulness as a part of the 
intervention.  One study currently underway of African American caregivers by Gaylord 
et al., is using a program similar to MIM DASH, except that the mindfulness-based 
stress reduction intervention is delivered by telephone.23  
There is a strong need for culturally sensitive strategies. Suggesting the 
importance of cultural tailoring of interventions, the uptake of REACH II was lower 
among African Americans than other races and there were no changes evident in self-
care or quality of life among those who did participate.20 Likewise African Americans are 
less likely than Whites to adhere to the DASH diet.24 PI Wright hypothesizes that 
chronic caregiver stress may also impact adherence.   
Stress reactivity/stress resilience is hypothesized as one of the key 
mechanisms underlying successful change in behaviors.25 Stress reactivity is the 
physiological response of the body to stress—activation of the cardiovascular system by 
increasing heart rate and blood pressure. Stress resilience is the process of adapting 
well in the face of significant sources of stress such as caregiver stress.26,27 Both are 
key mechanisms underlying successful change in behaviors.25 Thus, our multi-modal 
intervention that includes targeting stress resilience/stress reactivity has strong 
potential.  
Rigor of the Prior Research. Qualitative studies show that African American 
caregivers desire more support and education regarding self-care and diet to manage 
chronic conditions.12,13,28-30 However, studies of the culturally tailored DASH diet have 
lacked methodological rigor.31-36 None have investigated the mechanism of change in 
caregivers’ behaviors. While the REACH II and Savvy Caregiver studies use RCT 
design, psychoeducation, and translation across multiple settings,37,21 these studies 
have lacked equipoise in the attention control groups and did not to examine the 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
04-13-2023 
 
 
 
underlying mechanistic principles of behavior change. Questions remain regarding the 
stress and blood pressure self-care of African American women caregivers. 
Significance of the Expected Research Contribution. The study will address 
gaps in prior studies by providing equal attention to the intervention group and control 
group and using messaging appealing to African American women, focusing on the 
mind-body integration to promote self-care as opposed to caregiver burden.30,38,39 To my 
knowledge, this study will be the first to provide substantive information regarding the 
mechanistic action of stress reactivity/stress resilience, psychological and physiological 
response of the body to stress, and on self-care practices in African American female 
caregivers. These findings will lead to a larger RCT to examine the effectiveness of MIM 
DASH among African American female caregivers of PLWD. 
 
INNOVATION 
 
This proposal presents several innovations: 1) Use of the Information-Motivation-
Behavioral Skills model among African American women caregivers in the community 
setting, 2) combining mindfulness and healthy eating to address two high risk factors for 
adverse health outcomes represents a methodological shift; and 3) Examining the 
impact of the underlying mechanism of stress reactivity/stress resilience for the 
intervention.  
 
PRELIMINARY WORK  
Our preliminary work spans three studies of HTN self-care in older African 
Americans: an examination of self-care facilitators and barriers, a pilot of a co-created 
health education intervention, and MIM DASH.8,9,40,41 Preliminary findings indicate that 
MIM DASH works in older adults with mild cognitive impairment as SBP reduced by 7 
mm HG, which is clinically significant, in the intervention group compared to 0.7mmHG 
in the active control group., leading to the hypothesis that the intervention will be 
effective with hypertensive African American women caring for PLWD. The study also 
demonstrated the need for and feasibility of the current study. We saw the stress of 
African American women caregivers who were trying manage their own hypertension 
while keeping their family member with mild cognitive impairment safe. Demonstrating 
our ability to recruit, retain, and deliver health behavior interventions to African 
Americans, recruitment was smooth, with 30 participants signing up in 31 calendar 
days. It may be even smoother this time, as participants in those past studies educated 
us not to use the word “diet” which has a negative connotation (“diet means die”). I also 
witnessed the human aspect of this.  

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
04-13-2023 
 
 
 
The intervention has three components: knowledge of basic information 
regarding HTN, motivation though learning in a socially supportive environment, and 
behavioral skills to manage stress and HTN (Figure 1). The conceptual framework on 
which its promotion of health behavior change incorporates the Information-Motivation-
Behavioral Skills model.40,42 The antecedents are biologic characteristics such as age 
and co-morbidities that may influence outcomes. The Science of Behavior Change9 
indicates stress reactivity/stress resilience affects behavior change.43-46   Through the 
implementation of MIM 
to affect stress 
reactivity and promote 
stress resilience, we 
seek to change the 
body’s response to 
stress and influence 
the adoption of DASH 
self-care behaviors, 
lowering caregiver 
stress and improving 
SBP. 
 
STUDY PROCEDURES 
 
RESEARCH DESIGN 
Randomized-controlled trial. 
 
SAMPLE 
Sample. A sample of 90 African American women (age 40 and older) with a diagnosis 
of hypertension, who are caregivers of persons living with dementia (PLWD). 
 
Setting. In an effort to facilitate trust with potential participants, we intend to hire 
research staff who are ethnically similar to the participants. PI Wright and co-I Adams 
are both African American researchers and will assist study staff to explain study aims 
and protocols to the key stakeholders in the community. The study will take place via 
Zoom teleconference.  
 
Recruitment. We will recruit participants for the study from the African American Alzheimer’s 
and Wellness Association, the Ohio State University College of Nursing Total Health and 
Wellness clinic, Ohio State University Wexner Medical Center—Center for Cognitive 
Impairment, and Division of Geriatrics outpatient clinic. We will also advertise at churches, the 
Alzheimer’s Association Central Ohio Chapter webpage, Research Match, and on Facebook 
and Instagram. The estimated daily results from Facebook would reach from 1.1k - 3.3k persons 
and link clicks at 17-49 Columbus area. PI has an established relationship with members of the 
clergy in the African American community and is seen as a trusted source for health information 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
04-13-2023 
 
 
 
and collaboration. The project coordinator and PI will reach out to contact persons at each 
clinical and community site weekly to identify potential participants who meet inclusion criteria.   
 
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 consent form will obtain the participant’s permission to contact them in the future (yes/no). 
They are not required or obligated to provide their contact information for future research 
opportunities.  The contact information of participants, who agree to be contacted in the future, 
will be stored in the secure R: drive at the College of Nursing.   
 
Recruitment and Participant Informed 
Consent    
The steps to consenting are as follows:  
a. 
Potential participants would access the Informed Consent to Participate in 
Research via REDCap link provided on the study recruitment materials.  
b. 
The consent link will have a prescreen feature (Self-Screening Form).  
c. 
If a person says no to one of the inclusion criteria questions, they would be 
thanked and told that they do not qualify  
d. 
If the person meets the eligibility criteria, then the script for obtaining informed 
consent will appear.  
e. 
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.   
f. 
If the person checks yes, another survey would open to request their contact 
information (phone, email, mailing address)  
g. 
Participants who have reached this point will be contacted by research staff to 
complete a verbal screening including the AD-8 questionnaire and Post Completion of 
Online Consent form. 
  
Flyers will be posted at the respective study recruitment sites for potential participants, family 
members and staff to view. Research personnel will provide an overview of the study at staff 
meetings and community center gatherings (e.g., salons, barbershops, churches, and senior 
centers).  Those who are interested in participating will inform the research personnel of their 
desire to participate. Informed consent will be obtained as described above.  Only those study 
staff members that have completed CITI training will be permitted access to the participants.  
 
Documentation of Consent.  An Informed Consent Checklist form will be used for all 
participants.  All research staff will complete the elements of the checklist for every participant 
during the first Zoom meeting.  Elements include a check that the consent is in REDCap, the 
consent form is completed in full, the RA verifying that the consent form was completed, and 
that PI Wright reviewed medication list. The Informed Consent Checklist Form will be kept in the 
participants’ electronic file folders in the CON R:Drive.    
 
The participant can enter Zoom sessions by invitation only. If the participant does not have 
access to a touch screen tablet or computer, they may be able to borrow an iPad from the 
College of Nursing. This would be mailed to the participant with return postage paid.   
 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
04-13-2023 
 
 
 
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.  
 
Participant protection and Zoom. Using the Only authenticated users can join setting will 
prevent guests who do not have an Ohio State Zoom account from entering the session. Since 
the meeting includes non-university participants, the PI will use the following strategies to 
control who can attend.   
 Participants only with access can join  
 Turn off the option to Join before Host  
 Turn on the Waiting Room  
 Meeting will be password protected  
  
Zoom intervention sessions will not be recorded. Participants will be encouraged to use their 
camera to facilitate interaction. However, participants will be a given the choice to turn off their 
camera and microphone and use the Zoom Chat if they prefer.  Participants may use an avatar 
image of themselves in the Zoom room. Each cohort will chose a pseudonym for their cohort. 
Participants may share their contact information, not required, if they would like to support one 
another in their health goals. The study staff will not provide participants with each other’s’ 
contact information.  
 
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.  
  
 
AIMS AND MEASUREMENT/INSTRUMENTATION 
 
The data collection measures will be administered in both groups at baseline, 3, and 6 months. 
Data collection will take no longer than 120 minutes for each data collection session.  Data 
collection will take place via Zoom.  . Participant demographics and comorbidities will be 
collected at baseline. All other measures will be collected at baseline, 3 months, and 6 months 
as listed in Table 1. To accommodate the participants, who are caregivers, we will have the 
option for the study visits to be broken up into smaller 1 hour visits. To maximize flexibly for 
participants, they will have an option to receive the surveys electronically via REDCap to an 
email. Completed electronic questionnaires will be reviewed by the research coordinator for 
quality issues; he/she will follow up via text message when clarification is required. Text 
messages will be sent from Mosio via Short Messaging Service (SMS) or Multimedia Messaging 
Service (MMS). Participants will provide their cell phone numbers to add to the text-messaging 
platform, Mosio, to receive study communications. 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
04-13-2023 
 
 
 
 
AIM 1. Determine the feasibility of MIM DASH, MIM, and DASH for African 
American women caregivers of family/friends living with dementia. 
(Months 1- 42) 
Introduction and Rationale. The overall objective of Aim 1 is to provide data on 
processes to further hypothesis development and the successful implementation of a 
large RCT to test the effectiveness of MIM DASH on caregiver stress, self-care, and 
SBP.  This Stage I pilot study is based on the rationale that we can promote healthy 
lifestyle behaviors by addressing stress reactivity/stress resilience (psychological and 
physiological response of the body to stress) as the underlying mechanism to facilitate 
behavioral change. 
Design. PI Wright will conduct a two-arm RCT using 1:1:1 randomization to MIM 
DASH, MIM or DASH group sessions. All randomization will occur after the participants’ 
baseline data collection is completed. 
Setting and Sample. Biological variables. The study will include only African 
American women in this study because they: a) provide 60% of care to PLWD in the 
United States;10,11 b) have a lifetime risk of a single blood pressure reading of 130/80 
mmHg, signifying Stage I HTN, of 85.7%;46 c) are at increased risk of CVD due to the 
high prevalence of obesity, hyperlipidemia, HTN, and diabetes, particularly in 
association with chronic stress;46,47 and d) are 4.6 times more likely to have a stroke—a 
common consequence of uncontrolled HTN—than African American men.48 A 
convenience sample of 90 African American women throughout the United Stateswill be 
enrolled. Inclusion criteria are (1) diagnosis of HTN treated with an antihypertensive 
medication or risk of HTN that includes obesity and high cholesterol; (2) age 40 and 
older49 (3) a caregiver rating of the PLWD of 2 or greater on the Alzheimer’s Dementia-8 
scale;50 (4) providing unpaid care to a PLWD at least 10 hours per week or assisting 
with at least one instrumental activity of daily living51,52 (5) self-identifies as 
Black/African American; (6) English speaking; and (7) has access to a 
telecommunications device such as the internet via desktop, laptop/tablet, smartphone, 
or telephone. Exclusion criteria are (1) diagnosis of resistant HTN (blood pressure that 
remains above goal despite concurrent use of a diuretic/water pill and at least two other 
antihypertensive agents of different classes); or (2) active participation in 
mindfulness/yoga program.  
Recruitment procedures. Referrals will be obtained from the African American 
Alzheimer’s and Wellness Center, the Ohio State University (OSU) College of Nursing 
Total Health and Wellness clinic, Center for Cognitive Impairment, and Division of 
Geriatrics outpatient clinic. Advertising will also appear at churches, the Alzheimer’s 
Association Central Ohio Chapter, Research Match, and on Facebook—advertising 
throughout the United States.  
Study Procedures Overview. Enrollment. Consecutive potential participants will 
be screened and consented from the community or referral to the study staff.  
Consenting. Participants will complete a consent form and screening via secure 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
04-13-2023 
 
 
 
electronic survey such as REDCap. Data collection. Prior to scheduling baseline data 
collection via video/phone conference, trained study staff will obtain a medication list 
and administer the Alzheimer’s Dementia-8 scale. The Alzheimer’s Dementia-8 contains 
eight items that test for memory, orientation, judgment, and function (Cronbach alpha 
0.84).50  PI Wright or a designated co-I will review the medication list to verify that the 
participant is prescribed an antihypertensive. Other Significant Contributor (Addison-
cardiologist and AMFDP Fellow53) is available to answer subject-specific expertise 
questions as they arise regarding HTN. Baseline data will be over the 2-4 weeks prior to 
the start of the eight weekly group intervention sessions. To minimize burden, data will 
be collected from the participants via videoconferencing or phone. PI Wright has prior 
experience using this format for data collection for African American women.54 Using a 
REDCap database, the study staff will read data collection surveys to the participant 
and collect BP data per protocol in described in the study AIMS.  Trained study staff will 
collect baseline measures. Randomization. Upon completion of baseline data, 
participants will be randomized to MIM DASH, MIM, or DASH.  
Intervention Arms-Overview. Randomized participants will receive the MIM 
DASH, MIM or DASH intervention in eight weekly, 1-hour group sessions via telehealth 
(video and telephone access). Participants will receive session materials such as 
PowerPoint presentations so they can follow along by phone or videoconferencing. After 
completion of the eight weekly sessions, the participants will receive two follow-up calls 
per month to total 6 calls. The 3- and 6-month data will be collected as listed in the 
study AIMs.  A manual of operations will detail all procedures related to the protocol, 
including participant recruitment, data collection, database usage, and database 
management. 
Variables and data collection procedures. For feasibility of recruitment, PI 
Wright will track the number screened per month; number eligible; number enrolled per 
month; average time delay from screening to enrollment; and the completion of data 
collection.55 For acceptability, PI Wright will track treatment-specific preference ratings 
(pre- and post-intervention) and track treatment-specific preference ratings (pre- and 
post-intervention). The participants will complete a program acceptability 13-item survey 
using a Likert-type scale (1=strongly disagree, 5=strongly agree).56 Interventionists 
(trainers) will keep detailed intervention session records describing participant response 
to the intervention. The credibility scale consists of five statements for which participants 
indicate their confidence, with 1 being not at all and 10 being very confident. Higher 
cumulative scores, up to 50, will indicate greater credibility of the treatment condition. 
This will also aid in determining participants’ willingness to be randomized for future 
studies. 
PI Wright will use the research effectiveness, adoption, implementation, and 
maintenance (RE-AIM) model framework to strategize scalability of the project.57 Re-
AIM has five components: our ability to reach the target population, efficacy of the 
program, degree to which participants maintain health behaviors, the consistency of 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
04-13-2023 
 
 
 
implementation of the program, and the willingness of the interventionists to adapt to 
deliver the program. 
Analysis. PI Wright will conduct descriptive data analyses to check data 
accuracy, summarize participant characteristics, and examine variable distributions. 
Data anomalies once identified will be fully investigated and remedial strategies will be 
considered as appropriate. Descriptive statistics will indicate the feasibility and 
acceptability of the MIM DASH, MIM and DASH intervention, including a) approach-to-
enrollment ratio; b) proportion of participants that complete all eight sessions of 
assigned intervention arm and attention control arm; c) frequency of completion of the 
follow-up calls; d) proportion of days the study protocol is fully adhered to and 
proportion of protocol deviation among interventionists; e) mean rating of the 
interventions; and f) proportion of participants rating the intervention positively (4 or 
above). The results of the analysis will include point estimates along with 95% 
confidence intervals to indicate the precision of the estimates. Based on our experience 
enrolling African American participants in past studies, we have set feasibility at a) 
enrolling at least 40% of potentially eligible patients and b) completion of at least 75% of 
the assigned intervention. Acceptability will be defined by an average rating of 4 and at 
least 80% participants rating the intervention positively. 
 
AIM 2. Examine pilot efficacy of the MIM DASH intervention to improve stress and 
self-care as compared to active control groups (MIM or DASH).  
(6-42 months) 
Introduction and Rationale. Stress reactivity/stress resilience is a key 
mechanism underlying successful change in behaviors. Stress reactivity is the 
physiological response of the body to stress—activation of the cardiovascular system by 
increasing heart rate and blood pressure.26 Stress resilience is the process of adapting 
well in the face of significant sources of stress such as caregiving.26,27  Mindfulness 
practice, as a stress management behavior, may have an indirect effect on the adoption 
of healthy self-care behaviors by increasing perceived control over thoughts and 
elicitation of the relaxation response. 
Randomization Procedure. PI Wright will implement the randomization scheme 
generated by the study statistician to assign participants to the three treatment groups 
(MIM DASH, MIM, or DASH). Using a computer-generated random number sequence 
the study statistician will randomly allocate 90 recruited participants with a ratio of 1:1:1 
The assignment will be recorded in a secure database accessible only to the PI and 
pertinent study staff. The Research Assistant data collectors will be blinded to the 
assignment. 
MIM DASH (Intervention Group) Description. A trained MIM provider 
(layperson) and a registered dietitian will deliver the MIM DASH group intervention 
in eight 1-hour (30 minutes MIM and 30 minutes DASH) sessions via telehealth (video 
and telephone access). Participants will receive session materials such as PowerPoint 
slides so they can follow along by phone or videoconferencing. Each MIM session 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
04-13-2023 
 
 
 
consists of material related to mindfulness—the somatic mind/body connection, 
relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional 
reactivity. Group interaction centers on sharing ideas toward effective practice and 
practical daily challenges to being mindful. Each class begins with a prompt for 
participant contemplation that references a unique weekly theme which will be reiterated 
in the session materials. Then the participants will be led through a body scan, gentle 
stretching, yoga, progressive relaxation, and/or an eating meditation, and then into 
formal meditation. Each participant will receive mindfulness digital practice recordings 
as well as a weekly diary to document study activities. Participants will be instructed to 
perform mindfulness meditations at least five times a week and record the time in their 
diary (Figure 1 lists weekly topics by intervention group).  
The DASH portion, led by a registered dietitian, focuses on education to 
increase vegetables, fruits, and whole grains and decrease intakes of fat and sodium, 
sugar sweetened beverages, and sweets. Education includes adapting traditional “soul” 
food dishes to meet the DASH dietary guidelines. Participants will be provided with cost-
effective and practical tips to incorporate DASH in daily life. Repetition of key concepts 
will be embedded throughout the sessions to increase critical thinking and problem 
solving. After completion of the eight 1-hour sessions, the MIM DASH participants will 
receive six coaching calls (two per month for 3 months) to review MIM DASH 
principles/activities and support the participants’ continuation of self-care behaviors 
(mindfulness practice, healthy eating, and physical activity). 
 
Figure 1. Weekly topics by intervention group. 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
04-13-2023 
 
 
 
 
 
The MIM-only intervention group will receive the MIM education only in eight 
weekly sessions of 30 minutes each. To maintain equipoise among the intervention 
groups, this group will also have 30 minutes of “social time” to interact with the trainer 
and peers. To avoid cross contamination, the interventionist will not also deliver the 
intervention to the MIM DASH group.  Each participant will have access to the digital 
meditations with mindfulness practice recordings as well as a weekly diary to document 
study activities. Participants will be instructed to perform mindfulness meditations at 
least five times a week and record the time in their diary. After completion of the eight 
weekly sessions, these participants will receive six coaching calls (two per month for 3 
months) focused on mindfulness practice. 
The DASH-only group will receive the DASH education only in eight weekly 
sessions of 30 minutes each. This group will also have 30 minutes of “social time” to 
interact with the trainer and peers, will receive their education from a different 
interventionist (also a registered dietician) and receive two coaching calls per month for 
3 months, in this case focused on healthy eating DASH principles.  
Intervention fidelity (Table 1) will be evaluated to provide assurance that MIM 
DASH, MIM, and DASH are implemented as intended and will assure reproducibility of 
the protocol.  
Table 1. Intervention Fidelity58 

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Component                         Data used to Evaluate Intervention Fidelity                     
Design 
Detailed protocol manual for intervention sessions and common problem 
areas and weekly review of interventionist field notes. 
Training 
Research Staff Training: Pre-study simulations and observed data 
collection. Data collection accuracy at start-up and maintenance will be 
>.90. Interventionist Training: Each interventionist will complete 
training to competence under the supervision of PI Wright. All training 
will be video-recorded with feedback provided and corrected 
performance observed.  
Delivery 
Delivery of Intervention: Field notes will be recorded for all sessions as 
evidence of completion and to document barriers and facilitators to 
progress. Each interventionist will complete key component check list 
following each session to provide documentation of participant progress.  
Receipt 
List of participant responses to each intervention session. 
Enactment 
Weekly de-briefing of participants regarding performance of skills and 
strategies in “real-world” settings. Participant comments will be recorded 
in interventionist session logs,participant logs and diaries.  
 
Variables and Data Collection Procedures. Measures have been chosen 
based on their appropriateness for the study population, validity, reliability, and level of 
burden (Table 2). Records will include the participant’s self-report of age in years and 
list of comorbid diagnoses. The name, dose, and frequency of medications and 
supplements will be recorded from the participants’ bottles/containers at the baseline,  
3-, and 6-month visits. If participants do not bring their medication bottles to study visits, 
they can self-report medication information. 
The Science of Behavioral Change (recommended) Daily Inventory of Stressful 
Events will be used to measure stress reactivity/stress resilience. This end-of-day 
measure consists of a brief set of stem and conditional questions that can be can be 
administered via smartphone.59 Using ecological moment assessment methodology, the 
Daily Inventory of Stressful Events will be administered once a day for seven days at 
each data collection point—baseline, 3, and, 6 months. Additionally, 60 the PHQ-9, GAD, 
Everyday Discrimination Stress in the Healthcare Setting, Super Woman Schema, and 
the Memory Behavior Checklist will be used to quantify ADRD caregiver stress (stress 
inventories).61 The Perceived Stress Scale has 10-items one a Likert scale with a 
reference range of 0-30 regarding stress over the past month.62  Ten items on a Likert 
scale with a reference range of 0-30 regarding stress over the past month.62 The PHQ-9 
is a measure of depression and each item is scored on a scale of 0-3. The total ranges 
from 0-27 (scores of 5-9 are mild depression; 10-14 as moderate depression; 15-19 as 
moderately severe depression; and 20 severe depression). The Generalized Anxiety 
Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or 
assess the severity of generalized anxiety disorder (GAD). The GAD-7 represents an 
anxiety measure based on seven items which are scored from zero to three. The whole 

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scale score can range from 0 to 21 and cut-off scores for mild, moderate and severe 
anxiety symptoms are 5, 10 and 15 respectively. The Everyday Discrimination Stress in 
the Healthcare Setting  is a 7-item scale that examines the frequency and experiences 
of mistreatment while getting healthcare.  The scale has a Cronbach α of  0.89 and a 
test re-test reliability of .58 (p < .0001).  The Superwoman Schema (SWS) will be 
measured using the Giscombe Superwoman Schema Questionnaire which consists of 
35 items and five subscales to assess cognitive, behavioral, and affective endorsement 
and utilization of Superwoman characteristics by African American women 1. The score 
for each item ranges from 0 to 3 (0=This is not true for me, 1= This is true for me rarely, 
2= This is true for me sometimes, and 3= This is true for me all the time). The scoring 
will be conducted with the sum of each item, and possible scores range from 0 to 105. 
The summed scores will be averaged to indicate the superwoman schema. Higher 
scores indicate a greater degree of superwoman schema. In a previous study, 
Cronbach’s alpha of the total scale was 0.95, and the internal reliability of five subscales 
ranged from 0.72 to 0.89.  
Hair cortisol (will be used as a proxy for chronic stress. Hair samples will consist 
of approximately 25-75 mg of hair (approximate width of shoelace tip when bunched) 
cut  from the posterior vertex region of the scalp as close to the scalp as possible.63-66 
The posterior vertex has the lowest variation in cortisol levels, and is the preferred area 
for sampling.66 Participants will be surveyed on corticosteroid use as these medications 
may suppress cortisol levels, and on their hair care practices, such as frequency of 
washing, chemical treatments, and hair product use.67 To prep for assay, the hair 
sample is cut, then washed twice with isopropanol and dried over 1 to 3 days. A total of 
10-75 mg of hair is placed into a microcentrifuge tube, minced, and then ground in 
Retsch 400 Mill. A total of 1.1 ml of HPLC-grade methanol is added to the ground 
sample, which is incubated for 18-24 hours at room temperature with constant agitation. 
The tubes are centrifuged at 5000g for 5 minutes at room temperature to pellet the 
powdered hair. The entire amount (~1 ml) of supernatant is transferred to a clean 
microcentrifuge tube and the methanol is removed by evaporation using a stream of air 
for 6-8 hours at room temperature. The cortisol extract is reconstituted in 100ul of 
Salimetric immunoassay cortisol analysis diluent buffer. Samples are assayed in 
duplicate and inter- and intra-assay coefficients of variation calculated. Cortisol levels 
are expressed in hair as pg/mg and generally logged due to skewed distributions as 
needed.68 Participants will receive a hair kit and instructions for self-collection of the hair 
sample and a hair care practices survey (e.g., washing, coloring, or perming hair).  
 
Self-care practices will be measured using the Behavioral Risk Factor 
Surveillance System-physical activity69 and the Diet History Questionnaire (DHQ) III 
(sodium, fruits and vegetables, and fiber intake) for diet.70 71 She will provide additional 
support and training regarding data collection and interpretation of findings.  
Sample Size for Point Estimates (Power) based on AIM 2.  We propose a 
sample of 90 (30 per group) based on the feasibility of recruiting 90 participants within 
42 months and retaining at least 24 participants per group for 6 months of follow-up 

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(based on a dropout rate of 20%). Based upon other longitudinal studies with African 
Americans, we will sample in anticipation of a 30% all-cause attrition at 12-months.72,73 
In keeping with the pilot nature of this study, the sample size lacks the power to detect a 
small-to-medium effect size. On one of the primary outcomes, caregiver stress 
measured by the Perceived Stress Scale, the power ranges 41% - 65% to detect a 
fixed-effects of MIM DASH intervention with a medium effect size of 0.5 and a two-sided 
significance level of 0.05, assuming a residual standard deviation of 6 and a between-
visit correlation of 0.1 - 0.5.  
Statistical Analysis. We will conduct intent-to treat analysis. Descriptive 
statistics including mean and standard deviation will be used to summarize each 
primary outcome and secondary outcome. We will also report mean differences, 95% 
confidences intervals, and effect sizes for both within- and between-group differences at 
each visit. The fixed effect of MIM DASH intervention will be examined by mixed effects 
models. 
 
AIM 3. Examine the pilot efficacy of the combination of MIM plus DASH for 
improvement of systolic blood pressure as compared to active control groups 
(MIM or DASH).   
(6-42 months) 
Our rationale is that mindfulness practice will elicit a relaxation response.74-76 
DASH recommendations (physical activity, stress management, low-fat, low sodium, 
and high in fish, fruits, fiber and vegetables) will lower SBP and reduce the risk of 
CVD.3,77   
The 4-Item Krousel-Wood Medication Adherence Scale captures four domains of 
adherence behavior.78 Scores range from 0 to 4 with a score of 1 or greater indicating 
lower adherence. At baseline, PI Wright will provide training on the use of the BP 
monitor and American Heart Association infographics and video.79 The trained research 
assistant will obtain a remote measure of SBP using a Bluetooth automatic blood 
pressure Omron device under the direction of PI Wright. The participant will be 
instructed to sit quietly for 5 minutes, and take three measurements..80 The Omron is 
well-accepted equipment used in HTN research.81,82 
Sample Size and Power. Since this is primarily a feasibility study, the sample 
size (30 per group may not have sufficient power to detect small-to-medium effect sizes 
for between-group difference (e.g., 34% power to detect a Cohen’s d of 0.5 with a two-
sided significance level of 0.05). Therefore, the study will not rely on statistical 
significance. Rather, PI Wright will examine whether the intervention can achieve a 
clinically meaningful significant reduction in SBP defined as ≥ 5mm Hg.83 These 
estimates along with clinical significance will guide our results interpretation and inform 
the sample size determination required for an efficacy trial.   
Analysis. PI Wright will conduct intent-to treat analysis. Descriptive statistics 
including mean and standard deviation will be used to summarize each outcome. While 
controlling for use of medication for HTN, as measured on the Krousel-Wood 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
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Medication Adherence,78 I will use mixed-effects linear modeling to estimate the 
between-group difference in each outcome. From the mixed-effects modeling, I will 
derive estimates of the within-group difference of 3-months versus baseline measures, 
6-months versus baseline measures, and between-group (MIM DASH vs. MIM only and 
DASH only) difference in the change from baseline, adjusting for clustering from cluster 
randomization and repeated measures. This analysis will reveal whether, as 
hypothesized, SBP is reduced in the MIM DASH group as compared to both active 
control groups. 
 
MEASUREMENT/INSTRUMENTATION 
 
Table 2. Variable, measures, months, and reliability/validity 
Variables 
Measures 
Months (M) 
Reliability/validity 
 
 
Baseline 3M 6M 
 
Feasibility 
Acceptability Participant 
Preferences 
feasibility/acceptability 
survey, enrollment, 
attendance, and participant 
feedback 
Credibility scale 
X 
X 
 
 
 
 
 
X 
X 
 
SBP 
Home blood pressure 
monitor 
 
Krousel-Wood Medication 
Adherence 
X 
      
 
       X 
 
 
 
X 
 
 
X 
X 
   
 
 X 
 
 
 
 
C statistic= 0.70478 
 
 
Stress 
resilience 
/reactivity 
Daily Inventory of Stressful 
Events (seven days) 
 
Perceived Stress Scale 
 
Hair cortisol 
 
 
 
 
PHQ-9  
 
 
 
X 
 
 
X 
X 
 
 
 
 
 
X 
 
 
 
X 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
X 
 
 
X 
X 
 
 
 
 
 
X 
 
 
 
(Kappa) ranged 
from 0.66 to 0.9559 
 
α=  0.8367 
Hair correlation 
with 30-day saliva 
(r = 0.42, p = 
0.041)84 
 
 
α = 0.84 for patient 
behavior & 0.90 for 
caregiver reaction 
 

IRB Protocol Number: 
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04-14-2022 
Version: 
 
Expiration Date:  
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Variables 
Measures 
Months (M) 
Reliability/validity 
 
GADMemory & Behavior 
List 
 
Super Woman Schema 
 
Everyday Discrimination 
Stress in the Healthcare 
Setting   
X 
 
 
X 
 
X 
 
 
X 
 
X 
 
 
X 
 
X 
 
 
X 
 
X 
 
 
X 
 
X 
 
 
X 
 
α = 0.92 
 
 
 
 
α = 0.72 to 0.89 
 
 
α = 0.89 
Physical 
activity 
The Behavioral Risk Factor 
Surveillance System 
X 
X 
X 
α = 0.7069 
Dietary 
intake 
Diet History Questionnaire 
III  
X 
X 
X 
Correlation for 
energy between 
estimated truth 
and the DHQ = 
0.45 for women.70 
 
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 research team 
meetings. 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:   
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, 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
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02-07-2022 
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we will do a double data entry process.  PI Wright and or designated 
study staff will review the data collected and all related documentation.    
  
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 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.  
 
Protection of Privacy. For all potential participants, the data collection interviews will take place 
in a private room with closed door. All research team members will be certified with The Ohio 
State University (OSU) IRB, HIPAA, and CITI training. Careful training and supervision of all 
study staff will ensure procedures are carried out in accordance with established protocols.  
Timely team meetings (at least twice monthly) will be conducted to evaluate informed consent 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
04-13-2023 
 
 
 
procedures, study data collections, and other study activities to ensure consistency with planned 
study procedures. Should an adverse event occur, PI Wright will report this to the OSU IRB.    
  
Protection of Confidentiality.   Study staff will be carefully trained to protect participant 
confidentiality. They will work with participants to devise a plan for contacting them by phone, 
email, text messaging, or some other means determined by the participant, and decide whether 
or not messages may be left. Participants will be assigned a study identification number, and a 
master log will be created associating participant names and study number. The master log will 
be stored separately from data in the CON R: Drive folder.  Only the PI and designated study 
staff will have access to the master log, and the master log will be destroyed at the end of the 
study. Study staff access to study data will be determined based on the relevance to their 
responsibilities. Only aggregate data will be reported for the dissemination of study findings.   
  
Consents and any other forms with identifiable subject information will be maintained in a locked 
file separate from the filed study data which will be identified only by subject numbers. Data 
from questionnaires will be entered into REDCap.  Destruction of paper logs and forms will 
follow OSU protocols.  Findings will be reported in a manner in which individual data for specific 
participants are not identifiable.  
  
To mitigate the risk that participants violate the privacy and confidentiality of others in their 
group sessions, we will ask that those participants (and their family/support person) refrain from 
discussing other participants outside the group. Likewise, they will be asked not to acknowledge 
having met if they encounter each other elsewhere. These steps are not foolproof, and 
participants will be informed of the associated risks at the time of informed consent.   
  
Protection against Physical Harm. The study poses minimal risks to the participants.  All 
participants will receive the Blood Pressure Categories flyer from the American Heart 
Association and instructed to consult their provider if they have a systolic blood pressure higher 
than 180 mm Hg or diastolic blood pressure higher than 120 mm Hg. the participant would be 
instructed to seek immediate assistance or contact their provider.  The designated research 
staff member will attend all sessions.   
  
Protection against Psychological Harm. Survey questions are asked in a private setting and 
participants are reassured that they can refuse to answer any questions.  To further promote 
participant comfort, frequent breaks will be taken during data collection. From our previous 
experience, participants are able to complete the study questionnaires without a sense of 
burden.  To minimize emotional distress during the group sessions, interventionists and group 
leaders will be trained in observation for psychological or emotional discomfort as well as in how 
to deliver material in a supportive, nonjudgmental fashion.  If the interventionists or group leader 
observes discomfort, then the designated study staff member and or interventionist will offerto 
provide support privately. The designated study staff member will also notify PI Wright.     
  
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, 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
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02-07-2022 
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dissemination, and problem-solving with the research team.  The Community Advisory Board 
will meet bi-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.  
 
INTERNAL VALIDITY 
  
The study is a RCT with equal attention for both conditions.  We will repeat surveys measures 
over three time points (baseline, 1 month, 6 months) to reduce regression to the mean as an 
internal validity threat.  We have also employed strategies to improve participant retention.  
 
Retention.  Participants will be enrolled for 9 months.  We anticipate low drop out during this 
time.  However, should a participant drop out for any reason (illness, refusal, etc.), then 
additional participants will be enrolled to maintain sample size.   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.   
  
a. 
Data collection and intervention delivery option for weekends and evenings.    
b. 
Intervention delivery option for weekends and evenings.  
c. 
Reminder calls to participants for data collection and sessions.  
d. 
With permission from the participant, we will send text messages via Mosio,  
 
emails, and or phone call reminders for visits.  
e. 
Incentives include a $25 retail e-gift card given to participants  
at each data collection point (baseline, 3 and 6 months).  
  
Since participants may have a wait before baseline data are collected and the start of the group 
sessions, we have several incentives. We will send reminder greeting cards, postcards, and text 
messages to participants. In our experience, participants bond to such staff and remain in 
studies to a large degree because of the personal relationships and trust; a key component to 
working with the African American community. If an increase in missed visits occurs, the PI and 
the project coordinator will review with the RAs the root cause for the missed visits and review 
procedures for contacting participants.  
 
 
 
 
 
 
Mosio will be used as a two-way communication to participants  
 
 
 
 

IRB Protocol Number: 
2022B0064 
IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
10/27/2022 
02-07-2022 
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IRB Approval date:  12-02-2022 
04-14-2022 
Version: 
 
Expiration Date:  
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04-14-2022 
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02-07-2022 
04-13-2023 
 
 
 
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04-14-2022 
Version: 
 
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04-13-2023 
 
 
 
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