MoVE: Motivational Strategies To Empower African Americans To Improve Dialysis Adherence
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Sponsor: Vanderbilt University Medical Center

Principal Investigator:  Ebele M. Umeukeje, MD MPH           
  
 
 
 
 
 
Version:  05/10/22 v.05 
Study Title:  MOVE: MOtiVational Strategies to Empower African Americans to Improve Dialysis Adherence 
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MOVE: MOtiVational Strategies to Empower  
African Americans to Improve Dialysis Adherence 
 
Ebele M. Umeukeje MD, MPH 
Division of Nephrology, Department of Medicine 
Vanderbilt University Medical Center 
1161 21st Avenue South S-3223 MCN 
Nashville, TN 37232 USA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Principal Investigator:  Ebele M. Umeukeje, MD MPH           
  
 
 
 
 
 
Version:  05/10/22 v.05 
Study Title:  MOVE: MOtiVational Strategies to Empower African Americans to Improve Dialysis Adherence 
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Table of Contents: 
 
                  Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 Follow-up and Record Retention 
 
 
 
 
 
 

Principal Investigator:  Ebele M. Umeukeje, MD MPH           
  
 
 
 
 
 
Version:  05/10/22 v.05 
Study Title:  MOVE: MOtiVational Strategies to Empower African Americans to Improve Dialysis Adherence 
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1.0 
Background 
 
End stage kidney disease (ESKD) is a public health concern. High morbidity from ESKD accounts for 
more than 30% of the $30 billion Medicare ESKD budget and contributes to excessive ESKD-related 
hospitalizations. Higher hospitalization risk is observed in African Americans receiving hemodialysis, 
who have a four-fold higher prevalence of ESKD. Among ESKD patients, 35.4% are rehospitalized 
within 30 days compared to 15.3% of Medicare beneficiaries without kidney disease. African 
Americans constitute the highest proportion (36.2%) of this group. Non-adherence to dialysis 
treatment is key to increased risk of these outcomes. Compared to Whites, African Americans have a 
four-fold higher odds of hospitalization and higher dialysis treatment non-adherence rate. 
Psychosocial factors impact adherence behaviors in ESKD and associate with readmissions in patients 
receiving hemodialysis. Yet, interventions to reduce readmissions fail to focus on psychosocial factors. 
Optimal dialysis adherence behavior warrants evaluation of novel motivation-related psychosocial 
factors, such as optimism, apathy and autonomy. Optimism is a trait-like attitude which associates with 
health behaviors and predicts health outcomes. Apathy is a lack of motivation, which leads to a 
negative impact on goal-directed behavior. Autonomy is an essential factor for achieving durable 
behavior change. 
 
The hypothesis of this study is that culturally tailored motivational interviewing is feasible, 
acceptable, and will show preliminary efficacy in improving autonomy, apathy, optimism, and dialysis 
treatment adherence. This study will provide additional critical and timely information to reduce the 
excessive re-hospitalizations in end-stage kidney disease (ESKD) by intervening upon dialysis 
treatment non-adherence. It will address the need to rigorously advance the science and 
understanding of the development, feasibility, acceptability and adoption of novel culturally-sensitive 
motivational strategies to improve dialysis treatment adherence among African Americans with 
ESKD. This study is significant because it aligns with research priorities in dialysis care identified by the 
World Health Organization, the American Society of Nephrology, the Center for Medicare and Medicaid 
Services and patients with end-stage kidney disease. 
 
2.0 
Rationale and Specific Aims 
 
This study addresses the need to rigorously advance the science and understanding of the 
development, feasibility, acceptability and adoption of novel culturally-sensitive motivational 
strategies to improve dialysis treatment adherence among African Americans with ESKD. This 
study specifically aims to: 
 
1)  Gain advanced skills in the development and implementation of novel culturally sensitive 
motivational strategies 
2)  Acquire critical preliminary data for an R01-funded phase II efficacy trial testing the use of these 
motivational strategies to improve dialysis treatment adherence. 
 
 

Principal Investigator:  Ebele M. Umeukeje, MD MPH           
  
 
 
 
 
 
Version:  05/10/22 v.05 
Study Title:  MOVE: MOtiVational Strategies to Empower African Americans to Improve Dialysis Adherence 
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3.0 
Inclusion/Exclusion Criteria 
 
Inclusion Criteria:  
• 
African American 
• 
Receiving hemodialysis treatments 
• 
Been on hemodialysis for more than 30 days 
• 
18 years of age and older 
• 
Within a 3-month look back at the time of screening, patients who have missed at least one 
dialysis session or shortened at least one dialysis session by 15 minutes. 
 
Exclusion Criteria: 
• 
Not self-identified as African American 
• 
Impaired mental status or severe illness 
• 
Non-English speaking 
• 
No documented evidence of dialysis treatment non-adherence 
• 
Missed or shortened treatments due to hospitalizations or excused travel 
• 
Terminal condition 
• 
Living in a nursing home/rehab 
• 
Planned transplant within the next 3 months 
• 
Planned conversion to peritoneal dialysis within the next 3 months 
 
 
4.0 
Enrollment/Randomization 
 
1. Obtain consent by email from attending physicians to approach their hemodialysis patients (in 
person or over the phone) for study inclusion. Provide the Attending Physicians with pertinent 
details of the study and encourage them to share this information with their patients. 
 
2. With the permission of the Attending Physicians, review the dialysis clinic schedules/census to 
identify patients currently receiving hemodialysis therapy.  
 
a. Dialysis clinic locations 
i. Vanderbilt Dialysis Clinic:   
2906 Foster Creighton Drive Ste 200, Nashville, TN 37204 
ii. Vanderbilt Dialysis Clinic East:  
           20 Rachel Drive, Nashville TN 37214 
 
3. Approach patient in person in the dialysis clinics or via phone to discuss and invite participation 
(see subject participation script and phone recruitment script). In addition to information which 
the patients may have received from their Attending Physicians, answer any questions that they 
may have regarding the study, assess their interest in the study and do an initial screening. 
 

Principal Investigator:  Ebele M. Umeukeje, MD MPH           
  
 
 
 
 
 
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4. The randomization schedule will be generated and uploaded to Redcap by the biostatistician, 
and personnel will be masked until after enrollment. Personnel will be masked to patients' 
randomization status until after enrollment. After baseline enrollment into the study, 
participants as well as study personnel will no longer be blinded to participants' treatment 
assignments. Patients will be randomized to the intervention group (Arm 1) or to usual care 
(Arm 2) using a block randomization scheme. 
5.0 
Study Procedures 
 
1. See #4.0 above for enrollment procedures. 
 
2. Obtain signed informed consent in person, via phone or eConsent (see attached eConsent). 
a. Phone consent - If consent is taken over the phone a consent form will be mailed to the 
participant to obtain their signature with a request to mail it back in a self-addressed 
stamped envelope. 
b. eConsent- participant will be called, if they agree to participate and have capability, the 
REDCap link for eConsent will be emailed to the participant. 
 
3. Give copy of signed consent to patient in person or by mail and place copy of signed consent in 
dialysis medical record 
 
4. Administer surveys to all the subjects either orally, by phone, on paper, or electronically using 
mobile device depending upon the subject’s preference 
a. Patient Demographics Survey* 
b. Brief Health Literacy Screening (BHLS)*  
c. Social Desirability Scale (SDS)* 
d. Chronic Hemodialysis Knowledge Scale (CHeKS)* 
e. Perceived Kidney Knowledge Survey (PiKS)* 
f. Autonomous Regulation (AR) Scale 
g. Healthcare Climate Questionnaire (HCCQ) 
h. Perceived Kidney Disease Self-Management Scale (PKDSMS) 
i. 
Apathy Evaluation Scale (AES) 
j. Perceived Expectancies Index (PEI) 
k. Life Orientation Test-Revised (LOT-R) 
l. 
Adherence to Refills and Medication Scale (ARMS) 
m. Cook-Medley Subscale Baseline Questionnaire 
n. Center for Epidemiologic Studies Depression Scale (CES-D 10) 
o. Trust in Physician Scale (TPS) 
p. Readiness Ruler 
q. Time to Recover after Dialysis 
Surveys with an asterisk* are administered at Baseline ONLY. 
 

Principal Investigator:  Ebele M. Umeukeje, MD MPH           
  
 
 
 
 
 
Version:  05/10/22 v.05 
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5. Administer surveys at three different time points: Baseline, week 8-9, and week 12/closeout. 
 
6. Abstract medical records at baseline, week 8, and week 12. 
 
7. Administer motivational interviewing session to subjects in the intervention arm of the study (as 
determined using a block randomization scheme) 
a. Motivational interviewing sessions will either be done face-to-face or virtually given 
challenges imposed by coronavirus disease-19 (COVID-19) pandemic. Face-to-face 
sessions will be audio recorded. Virtual motivational interviewing will be done using a 
Health Insurance Portability and Accountability Act (HIPAA)-protected Zoom account. 
Initial session will take about 30 to 45 minutes. Follow up sessions will likely last less 
than 30 minutes. 
b. 10% of the motivational interviewing sessions will be coded by MI expert using the 
Motivational Interviewing Treatment Integrity Scale (MITI). 
c. The motivational interviewing script is attached separately. 
d. MI sessions will be conducted by certified health coaches. In preparation for the study, 
we will use standardized patients to assess the motivational interviewing skills of the 
health coaches. 
 
8. Provide subject with a $25 gift card as compensation for completing surveys at baseline, week 
8-9, and week 12/closeout; $25 gift card as compensation for completion of each motivational 
interviewing session: weekly for the 1st 4 weeks, week 6, and week 8; and $25 gift card for 
completion of post-intervention exit interviews (applicable to subjects in the intervention arm). 
 
9. Complete payment form each time subjects are compensated for MI visits and/or completion of 
surveys, and complete payment form for the post-intervention exit interviews.  
 
10. Summary of study activities and timeline: 
 
Procedure/Activity 
Frequency 
Survey completion 
3 time points 
Motivational interviewing (for intervention arm) 
6 time points 
Exit interviews (for patients in intervention arm) 
1 time point 
Medical record abstraction 
3 time points 
Dialysis adherence record abstraction 
From 3 months prior to enrollment to end of study 
 
 
 
 
 

Principal Investigator:  Ebele M. Umeukeje, MD MPH           
  
 
 
 
 
 
Version:  05/10/22 v.05 
Study Title:  MOVE: MOtiVational Strategies to Empower African Americans to Improve Dialysis Adherence 
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Variables 
3M prior 
W1 
W2 
W3 
W4 
W5 
W6 
W7 
W8 
W9 
W10 
W11 
W12 
Autonomous regulation 
X 
X 
X 
Autonomy support 
X 
X 
X 
Perceived competence 
X 
X 
X 
Apathy 
X 
X 
X 
Optimism 
X 
X 
X 
Intervention 
MI 
X 
X 
X 
X 
X 
X 
Clinical Outcome/ EMR 
Dialysis adherence 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Medical record abstraction 
X 
X 
X 
Logistical Outcomes 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening - enrollment ratio 
X 
Attendance to MI  
 
X 
X 
X 
X 
 
X 
 
X 
 
 
 
 
Drop-out rates 
X 
X 
X 
X 
X 
X 
Compensation 
MI visits 
X 
X 
X 
X 
X 
X 
Surveys 
X 
X 
X 
Exit Interviews 
 
 
 
 
 
 
 
 
X 
 
 
 
 
M – month, W – week, MI – motivational interviewing 
 
 
Brief exit semi-structured interviews with patients who receive MI 
The goal is to understand the perceptions, enablers and nurturers of the adoption of the culturally 
tailored motivational interviewing protocol to improve hemodialysis adherence. 
 
a. Exclusion criteria:  
I. African American hemodialysis patients who are not currently enrolled in this study 
II. African American hemodialysis patients who are not in the intervention arm of this study 
b. Clinic locations 
i. 
Vanderbilt Dialysis Clinic  
ii. 
Vanderbilt dialysis East clinic  
 
1. The facilitator guide for the semi-structured interviews is a separate attachment. 
 
 

Principal Investigator:  Ebele M. Umeukeje, MD MPH           
  
 
 
 
 
 
Version:  05/10/22 v.05 
Study Title:  MOVE: MOtiVational Strategies to Empower African Americans to Improve Dialysis Adherence 
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6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
 
The PI and all the research personnel will adhere to the required IRB policies. All the subjects will be 
closely monitored for any and all AEs related to either the study survey administration or the 
motivational interviewing sessions. These will be reported upon incident to the IRB within 7 calendar 
days as per IRB policy. In addition, the health coaches are to notify the PI and/or Research 
Coordinators if any concerning information comes up during the motivational interviewing session. The 
PI will be responsible for communicating any such information to the dialysis unit staff immediately. 
 
7.0 
Study Withdrawal/Discontinuation 
 
If the study participant decides to withdraw from the study, no additional information will be collected 
from them. This will have no impact on the care that they receive from their doctor. They are allowing 
us to use their information from this study for as long as we want. If they decide to withdraw 
permission, all they need to do is to let Dr. Umeukeje know. A decision to not participate in this 
research will not affect their treatment. 
 
8.0 
Statistical Considerations 
 
This study is a pilot test of a culturally tailored motivational interviewing intervention. Thus, the main 
focus of the statistical analyses is simply to generate estimates of treatment effects and variation and 
to evaluate feasibility outcomes and acceptability of a culturally tailored motivational interviewing 
intervention compared to usual hemodialysis care. 
 
Descriptive measures of autonomy, apathy, optimism, and dialysis treatment adherence will be 
calculated, including sample means, standard deviations, and quantiles. Estimated distributions of 
these variables will guide study design and power for a follow-up confirmatory clinical trial. Graphical 
displays of univariate and bivariate data will be created to generate hypotheses for the follow-up 
study. Data collection process will be assessed for completeness and accuracy and operating 
procedures for data collection will be developed to minimize missing data in the confirmatory clinical 
trial. 
 
The Vanderbilt Qualitative Research Core will provide qualitative analyses of the brief exit interviews 
done in this study. All interviews will be recorded and transcribed verbatim and analyzed using 
HyperRESEARCH software (version 3.5.2; Research Ware Inc., Randolph, MA). Open coding will be 
performed, and themes and sub-themes will be assigned to each idea fragment. The unit of data 
analysis will be the codes. Any discrepancies will be reconciled among coders. Themes will be 
categorized into the three domains of the PEN-3 model: Cultural identity; Cultural empowerment; 
Relationships and Expectations.  
 
 

Principal Investigator:  Ebele M. Umeukeje, MD MPH           
  
 
 
 
 
 
Version:  05/10/22 v.05 
Study Title:  MOVE: MOtiVational Strategies to Empower African Americans to Improve Dialysis Adherence 
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9.0 
Privacy/Confidentiality Issues 
All measures will be taken to ensure participant confidentiality during all phases of data collection, 
storage, and management. All patient data will be assigned a study ID number at the time of 
collection. Until the medical chart abstraction has been completed for all patients, a master key that 
contains patients name and date of birth or medical record number will be maintained on the secure 
VUMC server, in a password protected folder to which only the PI and mentors and approved study 
personnel have access. Once all data is collected for each individual participant, the linking information 
and their entry on the master key will be destroyed. The PI will subsequently maintain all de-identified 
data that is collected in this study. Hard copies will be kept separately in a locked file cabinet in the 
PI's or research coordinator's office. All materials will have a study ID number and no identifying 
information will be attached to any data (i.e., no names, address, phone number, medical record, 
social security number, or date of birth). A database will be created with the de- identified data and 
maintained by the PI in a password-protected folder on the Vanderbilt Redcap database. All 
video/audio recordings will be stored on the secure VUMC server. Only the KSP included in this IRB 
application will have access to the research information. This project will utilize the REDCap platform 
for data collection and management. This includes the ability for project team members listed as Key 
Study Personnel with existing electronic health record (EHR) system access rights to make use 
of REDCap Clinical Data Interoperability Services (CDIS) tools. These tools are designed to enable 
transfer of relevant study-related data from the Vanderbilt Research Derivative and/or directly from 
the EHR into REDCap. 
 
10.0 Follow-up and Record Retention 
 
Study duration is 2 years. Once all data is collected for each individual participant, the linking 
information and their entry on the master key will be destroyed. The raw data will be stored for 10 
years after the close of the study.