Addressing the Double Jeopardy of Stress and Hypertension Among African American Female Caregivers of Persons Living With Alzheimer's Disease and Related Dementias
Phase: NA
Conditions: Hypertension, Stress, Psychological
Sponsor: Ohio State University

 
Official Title: Stress and Hypertension in Dementia Caregivers 
NCT Number: NCT05721482 
Document Name: Study Protocol and Statistical Analysis Plan 
Document Date: August 8, 2023 
 
 
 
 
 
 

IRB Protocol Number:  2022B0031 
IRB Approval date:   
Version:  08/08/2023 
10/05/2022 
 
 
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INTRODUCTION 
 
No demographic group is more at risk for the double jeopardy of caregiving stress and hypertension 
(HTN) than African American women caring for a family member with Alzheimer’s disease and related 
dementias (ADRD). Both situations lead to reduced quality of life and cardiovascular disease—a complication 
of uncontrolled hypertension. Maintaining the health of these caregivers is critical to support the well-being of 
the care recipients. Although some multi-component interventions have addressed ADRD caregiver's stress 
and quality of life, gaps remain in targeting interventions to address the complexity of chronic caregiving 
stress and hypertension self-care in African American women. 
 
This pilot study builds on our earlier work which showed that stress, blood pressure knowledge, and complex 
diet information deficits all interfered with older African American women’s hypertension self-care. 
Lifestyle changes (stress management, reducing sodium, eating fruits/vegetables, and physical activity) are 
effective in managing hypertension. Our Stage I pilot study is based on the scientific rationale that we can 
promote these lifestyle changes by addressing stress reactivity/stress resilience, the psychological and 
physiological response of the body to stress, as the underlying mechanism to facilitate behavioral change. In 
this way we can improve health outcomes (caregiver stress, quality of life, cardiovascular disease risk).  
 
A small-scale two-group randomized controlled (RCT) pilot study of 28 African American female 
caregivers, age 40 and older with hypertension, will be conducted. We will determine the feasibility and 
acceptability of Mindfulness in Motion (MIM) plus the Dietary Approaches to Stop Hypertension (DASH). 
Participants will be randomized to either the MIM DASH intervention or the Alzheimer’s Association Caregiver 
Training (attention control) delivered in 8 weekly, 1-hour group sessions via telehealth (video and telephone 
access). After completion of the intervention, both groups will receive eight weekly and then four monthly 
coaching calls  or surveys through Mosio over the 9 months. To our knowledge, this is the first study that a) 
systematically employs one of the Science of Behavioral Change key mechanisms underlying successful 
adoption of health behaviors—stress reactivity/stress resilience and b) focuses solely on African American 
female caregivers of people living with dementia. The study aims are to:  
 
AIM 1. Determine the feasibility and acceptability of MIM DASH and Caregiver Training for African 
American female caregivers with hypertension. Hypothesis: MIM DASH and Caregiver Training groups will 
be feasible and acceptable to caregivers. Method: We will track feasibility: screening to enrollment, attendance, 
attrition, completion of data collection procedures; and acceptability: treatment-specific preference ratings (pre-
post intervention). The Credibility Scale will capture attitudes towards the treatment condition and the 
participants’ expectation of benefit once the treatment has been explained. Analysis: Feasibility and 
acceptability will be examined through descriptive statistics.  
 
AIM 2. Explore the impact of MIM DASH as compared to Caregiving Training on caregiver stress and 
QOL. Hypothesis: MIM DASH group will have improved caregiver stress and QOL as compared to the 
Caregiver Training group. Method: The Perceived Stress Scale will be used as a measure of caregiver stress 
and the level of cortisol extracted from hair will be a proxy measure of chronic stress. The World Health 
Organization-5 will be used to measure QOL. The data will be collected in person and documented in REDCap 
at baseline, 3, and 9 months post-intervention. Analysis: We will conduct intent-to treat analysis and the fixed 
effect of MIM DASH intervention will be examined by mixed effects models. 
 
AIM 3. Investigate the potential mediation effects of stress reactivity/stress resilience between MIM 
DASH or Caregiver Training and self-care behaviors. Hypothesis: Higher stress reactivity will diminish the 
relationship while higher stress resilience will enhance the relationship between MIM DASH and the adoption 
of self-care behaviors.  Method: Daily Inventory of Stressful Events and the Pittsburgh Stress Battery will be 
used to measure stress reactivity/stress resilience. Self-care behaviors will be measured using the Stress 

IRB Protocol Number:  2022B0031 
IRB Approval date:   
Version:  08/08/2023 
10/05/2022 
 
 
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Management Practices survey and the Block Food Frequency Questionnaire for the DASH eating index 
(includes physical activity). The 4-Item Krousel-Wood Medication Adherence Scale will be used to measure 
medication adherence. The data will be collected in person and online survey at baseline, 3, and 9 months 
post intervention. Analysis: The mediation analysis will be employed to examine this pathway. 
 
Impact. This pilot will make a substantive contribution to the science of behavior change by identifying 
basic mechanisms, in the adoption of healthy behaviors that can be used to implement self-care interventions 
to reduce health disparities in African Americans. Findings from the pilot study will inform the 
infrastructure for a larger trial.  
 
BACKGROUND AND RATIONALE 
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 (PLWD) with African American women providing 60% of this type of care. Although African 
American women generally endorse positive feelings about caregiving and express cultural justifications for 
providing care, they endure the adverse effects of chronic caregiver stress—increased cortisol and HTN. 
Indeed, HTN is the leading cause of cardiovascular disease (CVD) among African American women affecting 
56.7%. Yet, to our knowledge no behavioral intervention studies have addressed the dynamic interplay of 
chronic caregiving stress and HTN self-care in African American women. Our intervention, study thus 
addressees a significant gap.  
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), Savvy Caregiver, 
and Enhanced Physical Activity Intervention had a sufficient 
samples size of African Americans. However, in these 
studies, African Americans were less likely to experience 
success as other populations. The uptake of the intervention was lower among African Americans than other 
races and no there were no changes noted in self-care or quality of life. 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 telephone-delivered mindfulness-based stress reduction. Our intervention, Mindfulness 
in Motion plus the Dietary Approaches to Stop Hypertension (MIM DASH) compare to the one in Gaylord et al 
and thus may provide stronger benefit.  
There is a strong need for culturally sensitive strategies. Solid empirical evidence demonstrating 
the effectiveness of the DASH diet in reducing blood pressure. However, African Americans are less likely than 
Whites to be adherent to the DASH diet. We hypothesize that there are other confounders impacting 
adherence, specifically chronic caregiver stress.  
 
Stress reactivity/stress resilience is hypothesized as one of the key mechanisms 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 BP. Stress resilience is the process of adapting well 
in the face of significant sources of stress such as caregiver stress. Both are key mechanisms underlying 
successful change in behaviors. Thus, our multi-model 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. However, few studies of a 
culturally-tailored DASH diet have lacked methodological rigor. None have investigated the mechanism of 
change in caregivers’ behaviors. While the REACH II and Savvy Caregiver studies use randomized control trial 
(RCT) design, psychoeducation, and translation across multiple settings, these studies have lacked equipoise 
in the attention control groups and did not to examine the underlying mechanistic principles of behavior 
change. Questions remain unanswered regarding the stress and blood pressure self-care among African 
American women caregivers. 
“Caring for myself is not self-indulgence, it 
is self-preservation, and that is an act of 
political warfare.” ~Audre Lorde 

IRB Protocol Number:  2022B0031 
IRB Approval date:   
Version:  08/08/2023 
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Significance of the Expected Research Contribution. Our 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. 
To our knowledge, our 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 in 
this setting is novel among African American women caregivers, 2) Methodological shift by combining 
mindfulness and healthy eating to address two high risk factors for adverse health outcomes—caregiver stress 
and HTN; and 3) Examining the impact of the underlying mechanism of stress reactivity/stress resilience for 
this 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.  The 
findings demonstrate our ability to recruit, retain, and deliver health behavior interventions to African 
Americans. Our interprofessional team is well-poised to conduct this intervention study given our preliminary 
work that can be transferrable to hypertensive African American women caring for PLWD. The primary 
investigator has over 6 years’ experience conducting culturally informed research in this population. 
We incorporated the Information-Motivation-Behavioral Skills model in our conceptual framework to 
promote health behavior change. The antecedents are biologic characteristics that may influence outcomes. 
The intervention has three components: knowledge of basic information regarding an illness/disease (HTN), 
motivation though learning in a socially supportive environment, and behavioral skills to manage stress and 
HTN. The Science of Behavior Change indicates stress reactivity/stress resilience affects behavior change. 
Through implementation of Mindfulness in Motion to affect stress reactivity and promote stress resilience, we 
can change the body’s response to stress and influence the adoption of DASH self-care behaviors, lowering 
caregiver stress and improving QOL. 
 
STUDY PROCEDURES 
RESEARCH DESIGN 
Randomized-controlled trial. 
 
SAMPLE 
Sample. A sample of 28 African American women (age 40 and older) with a diagnosis of hypertension, who 
are caregivers of persons living with dementia (PLWD).  

IRB Protocol Number:  2022B0031 
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Version:  08/08/2023 
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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 in via telehealth with data collection occurring in-person.   
  
Sampling Plan. Our prior work in hypertensive African Americans demonstrates that we can enroll N=28 
caregivers. The total enrollment includes 28.6% oversampling to account for attrition. The composition of 
Blacks in the Columbus area is representative of the United States population at 22.86%. Forty-seven percent 
of Blacks in Ohio have hypertension. Most of the potential participants will be recruited from the African 
American Alzheimer’s and Wellness Center—sampling frame of 242 middle-aged African American women. 
From prior experience, we do not anticipate difficulty recruiting participants for this study.      
 
Eligibility Criteria: 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 older (3) a caregiver rating of the PLWD 
of 2 or greater on the Alzheimer’s Dementia-8 scale; (4) caregiver provides unpaid care to a PLWD at least 10 
hours per week or assists with at least one instrumental activity of daily living  (5) self-identifies as 
Black/African American; (6) English speaking; and (7) access to a telecommunications device such as the 
internet via desktop, laptop/tablet, smartphone, or telephone. Exclusion criteria are (1) expect to move out of 
the area within 9 months; (2) 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 (3) 
active participation in mindfulness/yoga program. The NIA Common Data Screening and Enrollment forms will 
be used to track data.   
 
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, Division of Geriatrics outpatient clinic, 
and Alzheimer's Association, Benjamin Rose, Miami University/Scripps Gerontology, Memory Lane Care, Ohio 
Council for Cognitive Health, Ohio Department of Aging, and the Summit County Public Health and other 
outpatient clinics. We will also advertise at churches, the Alzheimer’s Association Central Ohio Chapter 
webpage, distribute postcards, Research Match, and on Facebook/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 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 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)  
d. Email  
The consent form will also provide an opportunity to participate in future research. We 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.   
 

IRB Protocol Number:  2022B0031 
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Version:  08/08/2023 
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Recruitment and Participant Online Consent    
The steps to consenting are as follows:  
a. 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.  
b. The consent link will have a prescreen feature.  
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 verbal script for obtaining online 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 box would open to request their contact information (phone, email, 
mailing address). 
g. If the person checks yes, another question will prompt the participant to ask what their current blood 
pressure and/or diuretic/water pill medications are. PI Wright or a designated co-I will review the 
medication list to verify that the participant is prescribed an antihypertensive. 
  
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.  
 
Documentation of Consent.  A Consent Checklist  form will be used for all participants.  All research staff will 
complete the elements of the checklist for every participant.  Elements include verification that the consent is 
recorded in REDCap, the consent form is completed in full, the name of the study staff verifying that the 
consent form was completed, and that PI Wright reviewed medication list. The Consent Checklist Form will be 
kept in the participants’ electronic file folders in the CON R:Drive.      
 
Consent Addendum. The consent addendum will be available online. Study staff will contact the participants 
that were randomized to the MIM DASH group to provide them with the online link to the consent form using an 
addendum consent script.  
MEASUREMENT/INSTRUMENTATION 
 
The data collection measures will be administered in both groups at baseline, 3, and 9 months. The study 
team will attempt to collect data within 8 weeks of the anticipated study visit dates. Data collection will take no 
longer than 120 minutes for each data collection session.  Data collection will take place in the setting that is 
most convenient for the participant. For example, home or at the College of Nursing. Participant demographics 
and comorbidities will be collected at baseline. All other measures will be collected at baseline to 3, and 9 
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. Additionally, data that does not require an in person 
visit, such as questionnaires/surveys may be completed via phone or Zoom.  
 
At baseline, we will administer the 6-item Newest Vital Sign as to measure health literacy. The Newest Vital 
Sign has high internal consistency (Cronbach’s Alpha = 0.74). Validation against the Test of Functional Health 
Literacy in Adults demonstrated a Pearson’s r of 0.49 and an area under the ROC curve of 0.81 (Table 1).  
Scores range from 0-6 with lower scores indicating lower health literacy.  
 
For feasibility of recruitment, we 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.56 For 
acceptability, we will track treatment-specific preference ratings (pre- and post-intervention). For acceptability, 
we will track treatment-specific preference ratings (pre- and post-intervention).The participants will complete 

IRB Protocol Number:  2022B0031 
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Version:  08/08/2023 
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the Acceptability of Participant Preferences 13-item Likert-type survey ranging from 1 (strongly disagree) to 5 
(strongly agree). Interventionists will keep detailed intervention session records describing participant response 
to the intervention. For the MIM DASH group, we will collect data regarding usage of self-care equipment 
(home BP monitor and MyPlate) from follow-up calls or surveys. We will use a credibility scale for both groups 
regarding the expectation of benefits of the study. The Credibility Scale (α = 0.86) measures attitudes towards 
the treatment condition and the participants’ expectation of benefit once the treatment has been explained.59,60  
 
For participants randomized to the MIM DASH group, they will be asked to attend an interview with a study 
staff member that will last approximately 30 minutes. We will ask the participant several questions using an 
interview format. The answers provided will be used to help us better understand the participant’s perception 
regarding the DASH eating plan and how it could be adapted to better help African Americans reduce 
hypertension and cardiovascular disease risk. The staff will also record and transcribe the interview that occurs 
during the course of the study. The interview that occurs will be audio or video recorded and transcribed 
verbatim. The transcribed interview data will also be saved in REDCap and the recordings from the interview 
will then be destroyed. The identified information of participants who take part in the interview will be 
confidential. Qualitative descriptive methods will be employed for content analysis to elucidate emerging 
themes within the data. 
Table 1.  Data collection table of variables, measures, months, and reliability/validity statistics for instruments. 
Variables 
Measures 
Psychometrics 
 
 
Baseline 
3M 
9M 
 
Pre-Enrollment 
AD8 
NIA COMMON DATA SCREENING 
X 
 
 
 
Post-Enrollment 
NIA COMMON DATA ENROLLMENT 
X 
 
 
 
Biologic 
Age in years 
X 
 
 
 
List of comorbidities 
X 
Newest Vital Sign  
Measure health literacy (VS Score Sheet) 
X 
 
 
α = 0.74 
Self-care behaviors 
Stress skills management practices 
X 
X 
X 
α = 0.7175  
Block food frequency questionnaire (FFQ Booklet) 
DASH index-calculated from the block food frequency 
questionnaire 
X 
X 
 
X 
X 
Test-retest 
reliability, 
r=0.5976 
Mean correlation 
coefficient 
between 
frequencies 
of 
intake 
of 
55 
foods assessed 
by 2 FFQ 12 
months apart = 
0.57.77 
 
Medication list and BP log 
Krousel-Wood Medication Adherence 
X 
X 
X 
X 
X 
X 
 
C 
statistic= 
0.70478 
Stress reactivity 
/stress resilience 
Daily inventory of stressful events 
X 
X 
X 
(Kappa) ranged 
from 
0.66 
to 
0.9579 

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Version:  08/08/2023 
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Variables 
Measures 
Psychometrics 
Pittsburgh stress battery 
X 
X 
X 
Heart 
rate 
α 
=0.93; 
systolic 
BP; and α =0.92 
diastolic BP α 
=0.93.80 
 
Survey to Evaluate PBS 
 
 
X 
 
Stress/QOL 
Perceived stress scale (caregiver stress) 
Folkman 1 question regarding what is most stressful.  
X 
X 
 
X 
X 
α=  0.8367 
Discrimination in the Healthcare Setting is 7 questions 
on a Likert scale to measure the stress of 
discrimination in the healthcare setting as a result of 
age in ethnicity 
X 
X 
X 
α=  0.89 
Hair cortisol (chronic stress proxy) 
X 
 
X 
Correlation with 
30-day saliva (r = 
0.42, 
p 
= 
0.041)81 
WHO-5 (QOL) 
X 
X 
X 
Sensitivity (0.93) 
specificity (0.83) 
Depression- PHQ9 
Generalized Anxiety DisorderS 
PHQ9 has 9 questions  to evaluate mild, moderate, or 
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). 
X 
X 
X 
 α =0.90 
 
. α = 0.92 
 
Revised Memory and Behavior Checklist 32-item check-list that assess activities of daily living 
and problem behaviors in people living with ADRD 
X 
X 
X 
α = 0.84 
 
Discrimination 
Discrimination in the Healthcare Setting is 7 questions 
on a Likert scale to measure the stress of 
discrimination in the healthcare setting as a result of 
age in ethnicity 
X 
X 
X 
α = 0.89 
Credibility  
Credibility Scale 
 
X 
 
 
Acceptability 
Acceptability of Participant Preferences 
Interview questions  
 
X 
 
X 
 
 
The scale consists of 5 questions rated on a 0 (not at all confident) to 10 (very confident). Higher scores, up to 
45, will indicate greater credibility of the treatment condition. This will also aid in determining participants’ 
willingness to be randomized for future studies.  
 
The Perceived Stress Scale has 10-items one a Likert scale with a reference range of 0-30 regarding stress 
over the past month.  Hair cortisol (HC) will be used as a proxy for chronic stress. To collect the hair samples, 
approximately 25-75 mg of hair (approximate width of shoelace tip when bunched) will be cut  from the 
posterior vertex region of the scalp as close to the scalp as possible. The posterior vertex has the lowest 
variation in cortisol levels, and is the preferred area for sampling.   Participants will be surveyed on 

IRB Protocol Number:  2022B0031 
IRB Approval date:   
Version:  08/08/2023 
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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. 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, and incubated for 18-24 hours at room temperature with constant agitation. The 
tubes are centrifuged at 5000g for 5 min 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. HC levels are expressed in hair as pg/mg and generally 
logged due to skewed distributions as needed. Our team has experience collecting and processing hair 
samples from African Americans. The World Health Organization (WHO-5) is a short questionnaire consisting 
of five Likert scale statements of well-being over the past 2-weeks.  Scores range from 0-25.  The Memory 
Behavior Checklist  assesses psychological comorbidity of the caregiver and health status of the person living 
with ADRD. The Memory Behavior Checklist (α = 0.84) is a 32-item check-list that assess activities of daily 
living and problem behaviors in people living with ADRD. Scores range from 0-96 with higher indicating more 
behavioral problems in the care recipient. 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).82  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 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. These data will be collected at baseline, 3, and 9 
months.  
 
Hair cortisol (HC) will be used as a proxy for chronic stress. To collect the hair samples, approximately 25-75 
mg of hair (approximate width of shoelace tip when bunched) will be cut  from the posterior vertex region of the 
scalp as close to the scalp as possible.  The posterior vertex has the lowest variation in cortisol levels, and is 
the preferred area for sampling. 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. 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, and incubated for 
18-24 hours at room temperature with constant agitation. The tubes are centrifuged at 5000g for 5 min 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. HC 
levels are expressed in hair as pg/mg and generally logged due to skewed distributions as needed. Hair 
samples will be collected at baseline and 9 months.  
 
Daily Inventory of Stressful Events was taken from the Science of Behavioral Change Research Network list of 
instruments recommended to assess stress reactivity/stress resilience. The instrument is a semi-structured 
survey in which participants report whether any stressful events had occurred within the past 24 hours. This 
instrument yields several variables for each reported stressor including: (a) content classification of the 
stressor for example, work overload, argument over housework, or traffic problem); (b) subjective severity of 
stressors; (c) primary appraisals (areas of life that were at risk because of the stressor); and (d) perceived 
control of the situation.” Scores range from 0 to 27. This instrument will be distributed via an automated texted 
link from Mosio. Pittsburgh Stress Battery is a test of BP response to stress that is indicated as a measure of 
stress reactivity by the Science of Behavior Change Research Network. The participants are given a series of 
tests that include the Stroop test, mirror tracing, and mental math. For example, participants will be given three 

IRB Protocol Number:  2022B0031 
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Version:  08/08/2023 
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trials of basic arithmetic problems lasting one minute per trial.  Participants who scores 60% or greater, will 
advance to the Random-Medium level; those who do not will repeat Easy. Prior to the 3rd trial, the data 
collector will place the BP cuff on the participants left arm unless contraindicated. At the 30-second mark of the 
3rd math trial, the data collector will use an automatic BP machine (clinician grade) to measure systolic BP, 
diastolic BP and heart rate. Significant Other Collaborator, Nguyen is a neuropsychologist and will assist with 
training data collectors to administer the test and interpretation of data. Survey to Evaluate the Pittburgh Stress 
Battery is a one-question Likert scale to evaluate how challenging the participants found the PBS to be. Self-
care behaviors are measured using Stress Management Practices survey part A, a list of 13 statements such 
as “I am able to use muscle relaxation techniques to reduce any tension I experience” that is measured on a 
Likert scale. Scores range from 0 to 52 with higher scores indicating greater use of stress management 
strategies. Block Food Frequency Questionnaire (includes physical activity) 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 offers nine continuous responses ranging from “never” to 
“every day” for most foods. The DASH Index that is calculated using data from the Block Food Frequency 
Questionnaire uses a quintile system to score foods related to the DASH diet. All of the components are 
equally weighted. Intake of vegetables, fruits (including fruit juice), nuts and legumes, whole grains were 
scored from 1 (lowest quintile) to 5 (highest quintile). The overall DASH component scores range from 8 to 40. 
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. These data will be collected 
at baseline, 3 and 9 months. To reduce participant burden, the Block Food Frequency Questionnaire data will 
be collected at baseline and 9 months. 
 
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).  
These data will be collected at baseline, 3 and 9 months. 
 
INTERVENTION  
MIM DASH Intervention. A trained MIM provider and 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. Participants will receive weekly email reminders to participate with the link to join the virtual 
meeting and reminders of what participants will need to do to prepare for the session. Each MIM session 
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 during the next hour that reference a unique weekly theme which will be reiterated in 
the session materials. Handouts. 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 a compact disk player, digital Mp4 file, or YouTube link via Mosio 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. The DASH portion, led by the 
Registered Dietitian, focuses on education to increase vegetables, fruits, 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 practical tips to incorporate 
DASH in daily life. They will receive an individual MyPlate displaying serving sizes and food groups comprising 
a balanced meal and a home BP monitor. PI Wright will provide training on the use of the BP monitor and 
American Heart Association infographics and video. Repetition of key concepts will be embedded throughout 
the sessions to increase critical thinking and problem solving. After completion of the 8-week sessions, the 
MIM DASH participants will receive eight weekly and then four monthly coaching calls or surveys to review 

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sessions and support the adoption of self-care behaviors. Our team has experience in delivering the MIM 
DASH intervention for older African Americans with hypertension.   
  
Caregiver Training-Attention Control. A trained interventionist will deliver the Caregiver Training.  
Participants in this group will attend eight 1-hour group lessons via telehealth for 8 weeks. We will use  
Alzheimer’s Association caregiver training resources on topics such as Healthy Living for Your Brain and Body: 
Tips from the Latest Research; Dementia Conversations: Driving, Doctors Visits, Legal and Financial Planning; 
and Understanding and Responding to Dementia-Related Behavior. Similar to the MIM DASH group, 
participants will receive educational materials so they can follow along using videoconferencing or phone. 
Participants will have group discussion and role play using case study scenario. They will receive eight weekly 
and then four monthly social calls to maintain participants’ involvement and enhance participant retention. Our 
team has experience working with attention control groups for African Americans. At the end of the study, the 
Caregiver Training group will receive a home BP monitor, a MyPlate, and American Heart Association home 
BP infographic and video. They will also have the opportunity to receive a short video describing MIM DASH 
after the study ends. The MIM DASH group will receive instead the Caregiver Training materials.    
 
There will be additional short video and educational materials for MIM DASH and Caregiver Training will be 
submitted as an amendment for IRB approval prior to participants viewing materials.  
 
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 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.  
 
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  
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.  
 

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Intervention fidelity (Table 2) will be evaluated to provide assurance that MIM DASH and Caregiver Training 
are implemented as intended and will assure reproducibility of the protocol. The MIM DASH group will receive 
the Caregiver Training materials at the conclusion of the study.  
 
Component                                                   Data used to Evaluate Intervention Fidelity                                        Table 2. 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 and 
Co-I’s Klatt, and Adams. 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. 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.  
 
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, 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.    
  

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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 consent 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 consent.   

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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 take the participant to a 
quiet area to provide support. 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, 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, 9 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. Participants will also receive a home blood pressure monitor and a MyPlate depicting a well-balanced 
diet of protein, fruit/vegetables, and carbohydrates.   
e. Free parking or round trip transportation is provided for data collection.  
f. 
With permission from the participant, we will send text messages, emails, and or phone call reminders 
for visits.  
g. Incentives include $50 cash  given to participants at each data collection point (baseline, 3 and 9 
months).     
h. Data collectors will be available to go to the participant’s preferred location if they do not want to come 
to the College of Nursing.  
  

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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 unexpected token gifts (each 
valued at under $7, e.g., water bottle, cinch bag) 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. PI Wright has established community relationships with key 
stakeholders including the American Heart Association, Franklin County, Franklin County Hypertension 
Network, and local churches. 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.  
  
Dr. Wright will monitor any adverse events that arise in the course of the study. Any adverse events will be 
reported in writing to Ohio State University IRB. The PI will stop any data collection for the aim in which there 
has been an adverse effect until the adverse effect is resolved. A Safety Officer will be appointed to provide 
oversight of data collection and analyses. If the needs arise, a data safety and monitoring board will be formed. 
Given the low risks associated with lighting intervention (non-pharmacological education intervention), we do 
not foresee a need for a DSMB, but we will be working with a Safety Officer who can provide independent 
oversight of the project.   
 
DATA ANALYSIS 
 
Aim 1. Analysis.  We 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. We will use descriptive statistics to examine the 
feasibility and acceptability of the MIM DASH intervention and Caregiver Training, 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 or surveys; d) proportion of days the 
study protocol is fully adhered to and proportion of protocol deviation among interventionists; e) mean rating of 
MIM DASH intervention; and f) proportion of participants rating the MIM DASH  intervention positively (4 or 
above). We will report point estimates along with 95% confidence intervals to indicate the precision of the 
estimates. Based on our experience enrolling African American participants in studies, feasibility will be defined 
by: 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 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 Analysis. We will conduct mediation analysis for both groups. Each variable will be first summarized by 
descriptive statistics. Then we will examine the mediation effects of stress reactivity/stress resilience between 
the MIM DASH intervention or Caregiver Training and behavior change. The estimated mediation effects and 
95% confidence intervals will be reported