Improving Healthcare Outcomes in American Indian and Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology (IMPACT)
Phase: NA
Conditions: Kidney Replacement
Sponsor: University of New Mexico

PROTOCOL TITLE: Improving Healthcare Outcomes in American Indian and 
Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology 
(IMPACT)
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PROTOCOL TITLE:
Improving Healthcare Outcomes in American Indian and Hispanic Transplant 
Recipients Using Culturally-Tailored Novel Technology (IMPACT)
PRINCIPAL INVESTIGATOR:
Larissa Myaskovsky, PhD
Department of Internal Medicine, Division of Nephrology
Center for Healthcare Equity in Kidney Disease
ADMINISTRATIVE CONTACT:
Nila S. Judd
Office of Research
Center for Healthcare Equity in Kidney Disease
VERSION NUMBER:
9.0
DATE:
July 13, 2021
REGULATORY FRAMEWORK:
Please indicate all that apply:
DOD (Department of Defense)
DOE (Department of Energy)
DOJ (Department of Justice)
ED (Department of Education)
EPA (Environmental Protection Agency)
FDA (Food and Drug Administration)
HHS (Department of Health and Human Services)
VA
Other:      
FUNDING:
Dialysis Clinic, Inc.
CLINICAL TRIALS
Is this a clinical trial per the NIH definition of a Clinical Trial?   
 Yes   
 No

PROTOCOL TITLE: Improving Healthcare Outcomes in American Indian and 
Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology 
(IMPACT)
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NIH Definition of a Clinical Trial: 
A research study in which one or more human subjects are prospectively assigned to one 
or more interventions. An "intervention" is defined as a manipulation of the subject or 
subject’s environment for the purpose of modifying one or more health-related 
biomedical or behavioral processes and/or endpoints. Examples include: drugs/small 
molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery 
systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related 
behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment 
strategies; prevention strategies; and, diagnostic strategies (which may include placebo or 
other control) to evaluate the effects of those interventions on  health-related biomedical 
or behavioral outcomes. 
Use the following four questions to determine the difference between a clinical study 
and a clinical trial:       
1)
Does the study involve human participants? 
 Yes   
 No
2)
Are the participants prospectively assigned to an intervention? 
 Yes   
 No
3)
Is the study designed to evaluate the effect of the intervention on the participants? 
 Yes   
 No 
4)
 Is the effect being evaluated a health-related biomedical or behavioral outcome? 
 Yes   
 No
Note that if the answers to the 4 questions are yes, your study meets the NIH definition of 
a clinical trial, even if… 

You are studying healthy participants

Your study does not have a comparison group (e.g., placebo or control)

Your study is only designed to assess the pharmacokinetics, safety, and/or 
maximum tolerated dose of an investigational drug

Your study is utilizing a behavioral intervention
If yes to all 4 questions, please confirm that the research team is familiar with and agrees 
to comply with the investigator requirement to register the study on the ClinicalTrials.gov 
database. Additionally, the approved consent document(s) must be uploaded to the 
ClinicalTrials.gov database    
 Yes   
 No 
For any assistance with registration of your trial or the requirements, please contact HSC-
CTSCResearchConcierge@salud.unm.edu 

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Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology 
(IMPACT)
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Table of Contents
1.
Objectives..............................................................................................................................................6
2.
Background..........................................................................................................................................6
3.
Study Design........................................................................................................................................6
4.
Inclusion and Exclusion Criteria.................................................................................................6
5.
Number of Subjects ..........................................................................................................................6
6.
Study Timelines..................................................................................................................................7
7.
Study Endpoints.................................................................................................................................7
8.
Research Setting ................................................................................................................................7
9.
Resources Available .........................................................................................................................7
10.
Prior Approvals..............................................................................................................................8
11.
Multi-Site Research......................................................................................................................8
12.
Study Procedures..........................................................................................................................9
13.
Data Analysis................................................................................................................................10
14.
Provisions to Monitor the Data to Ensure the Safety of Subjects..........................10
15.
Withdrawal of Subjects............................................................................................................10
16.
Data Management/Confidentiality.....................................................................................11
17.
Data and Specimen Banking..................................................................................................12
18.
Risks to Subjects.........................................................................................................................13
19.
Potential Benefits to Subjects ...............................................................................................13
20.
Recruitment Methods...............................................................................................................13
21.
Provisions to Protect the Privacy Interests of Subjects.............................................14
22.
Economic Burden to Subjects ...............................................................................................14
23.
Compensation..............................................................................................................................15
24.
Compensation for Research-Related Injury ...................................................................15
25.
Consent Process..........................................................................................................................15
26.
Documentation of Consent.....................................................................................................18
27.
Study Test Results/Incidental Findings ...........................................................................19
28.
Sharing Study Progress or Results with Subjects.........................................................19
29.
Inclusion of Vulnerable Populations..................................................................................20
30.
Community-Based Participatory Research.....................................................................21
31.
Research Involving American Indian/Native Populations.......................................21
32.
Transnational Research...........................................................................................................21
33.
Drugs or Devices.........................................................................................................................22
34.
Principal Investigator’s Assurance.....................................................................................22
35.
CHECKLIST SECTION................................................................................................................24
36.
Partial Waiver of Consent for Screening/Recruitment..............................................24
37.
Partial Waiver of HIPAA Authorization for Screening/Recruitment...................25
38.
Waiver of Documentation of Consent ...............................................................................25
39.
Alteration of Consent................................................................................................................26
40.
Full Waiver of Consent/Parental Permission ................................................................27
41.
Full Waiver of Consent/Parental Permission (Public Benefit or Service 
Programs) ...................................................................................................................................................28
42.
Full Waiver of HIPAA Authorization (Checklist)..........................................................28
43.
Other Waiver Types (Checklist)...........................................................................................29

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Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology 
(IMPACT)
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44.
Vulnerable Populations (Checklist)....................................................................................29
45.
Medical Devices (Checklist)...................................................................................................35
46.
Export Control (Checklist) .....................................................................................................36
47.
Data Transfer/Sharing (Checklist).....................................................................................36
48.
Specimen Transfer/Sharing (Checklist)...........................................................................37

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Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology 
(IMPACT)
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1. Objectives
Aim 1:  Examine IMPACT’s acceptability and feasibility in AI and HL KT recipients.
1a. We will assess acceptability by patient ratings of satisfaction with the culturally-
tailored diet and exercise intervention, as well as the Twistle patient engagement 
platform.
1b. We will assess feasibility by determining recruitment and retention rates and 
assessing participant adherence to the IMPACT intervention.
1c. We will determine the ideal personnel hours and number of staff required for the 
physical therapist/exercise physiologist and registered dietitian nutritionist roles.
Aim 2:  Test the efficacy of IMPACT on proximal outcomes (e.g., weight, lipid 
profile, HbA1c, sleep quality, QOL) and distal outcomes (e.g., occupational 
functioning) in kidney transplant recipients.
2a. We will assess participants’ adherence to the exercise and diet intervention 
aspects of IMPACT.
2b. We will begin to examine the relationship between adherence to IMPACT and 
patient outcomes.
2. Background
Kidney transplantation (KT) is the treatment of choice for patients with end-stage 
kidney disease (ESKD). Although KT reduces cardiovascular events, cardiac death rates 
in KT recipients remain up to 10 times greater than in the general population.1,2 Similarly, 
KT recipients with diabetes-associated ESKD have higher mortality rates compared to 
recipients with ESKD due to other causes.3,4 New-onset diabetes after transplantation is 
also a major contributor to the burden of cardiovascular disease.5,6 Further, although 
aggressive treatment with post-transplant immunosuppressive agents7,8 has decreased 
rejection, use of these agents is associated with a host of other complications, such as 
hyperlipidemia, hypertension, post-transplant diabetes, and glomerulopathy.9-22 
Currently, the most common approach to treating these cardiometabolic complications is 
medication. However, medications are limited in their effectiveness,2,23,24 and patients 
may face contraindications and unwanted side-effects, given their complex post-
transplant immunosuppression regimen.9-22 Given the tremendous resources that go into 
evaluating and transplanting ESKD patients, it is important to explore effective, yet less 
costly, approaches to reducing cardiovascular and diabetes-related risk post-transplant.2 
Weight gain in the first year after KT, and especially an increase in fat mass, is a very 
common contributor to elevated cardiometabolic risk. In addition, low levels of physical 
activity and reduced physical functioning are common after KT, associated with a 
reduced quality of life (QOL)25 and poor sleep quality.26 Lifestyle modification (dietary 
changes and exercise) has been the mainstay for initial management of diabetes and 
cardiovascular disease for decades in the general population. Because of the presence of 
both traditional and transplantation-specific risk factors for cardiovascular events and 
diabetes after transplantation,27-29 it is important to validate the feasibility and efficacy of 
an early post-transplant lifestyle modification specifically for the KT population.30 
Although an approach specifically tailored to KT recipients may be an optimal 
solution,31,32 Takahashi’s33 seminal review of physical activity in the KT population 
noted that previous programs had limited testing (e.g., small sample sizes; brief follow-

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Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology 
(IMPACT)
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up),17,33-35 and have not resulted in specific lifestyle management guidelines for KT 
recipients.36 Similarly, a recent Cochrane review of dietary interventions for adults with 
CKD37 highlighted the limitations of current evidence of dietary interventions on CKD 
patients. Further, a meta-analysis of multi-behavior lifestyle interventions in chronic 
disease and community populations38 found that most intervention studies are targeted at 
White (WH) or African American (AA) patients, with lowest representation of American 
Indian (AI) or Hispanic/Latina(o) (HL) populations; overall, only 10% of interventions 
were culturally appropriate to the target population. 
In Improving Healthcare Outcomes in American Indian and Hispanic Transplant 
Recipients Using Culturally-Tailored Novel Technology (IMPACT), we will pilot the 
feasibility and acceptability of a culturally-tailored, multi-behavior lifestyle intervention 
using a novel technology for 14-20 AI, HL, and White KT recipients. Because of KT 
recipients’ varied stability immediately post-transplant, and the need to individually 
monitor their post-transplant immunosuppression regimen,1,23,24,33 a critical component of 
IMPACT will be an individually-tailored exercise and diet plan with a physical 
therapist/exercise physiologist and a registered dietitian nutritionist, who will work 
closely with the post-transplant team to carefully monitor patient stability. IMPACT will 
combine a personalized assessment of the patient’s food preferences and access to 
exercise resources within their environment (based on a standard list of factors developed 
by our nutrition and rehabilitation experts) along with clinical specifications from the 
transplant team. Our study is innovative because it addresses previous limitations,33,37 
while adapting the intervention to meet the needs of the culturally-diverse ESKD 
population. The final innovation of the IMPACT Pilot is our use of the Twistle Patient 
Engagement Platform39 to follow-up with participants between their scheduled 
appointments, ensure adherence to the intervention, collect all questionnaire data, and 
enhance participant retention.
3. Study Design
Due to heterogeneity among the exercise programs used in previous post-KT studies, 
it is difficult to make definitive conclusions regarding the benefit of aerobic versus 
resistance training.33 Thus, our project is innovative because it combines instruction 
that is professionally guided by a therapist, and incorporates a rehabilitation 
approach to slowly increasing KT recipients’ physical activity40-42 until they can 
engage in exercise at levels consistent with the KDIGO guideline. We argue that in the 
current era of personalized medicine, it would not be appropriate to prescribe one form of 
exercise across all patients. Rather, a tailored approach to physical rehabilitation with the 
end goal of a patient’s ability to meet the KDIGO guidelines (and within their specific 
cultural environment) is optimal for patient health and outcomes. Our intervention is 
innovative because it addresses the limitations identified by Takahashi’s33 review of 
physical activity and the Cochrane review of dietary guidelines37 in the KT population, 
while having the capacity to be culturally adapted to meet the needs of the diverse ESKD 
population that exists in the US today.
Another innovation of our approach is to work with the existing resources of the 
core transplant team in any transplant center (namely, the transplant registered 
dietitian) and empower that team member to develop a culturally-tailored diet approach 

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Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology 
(IMPACT)
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Figure 1.  Screen shots of Twistle patient engagement platform
that helps patients reduce weight gain, lower their HbA1c levels, and decrease their risk 
of post-transplant cardiovascular events. This is an innovative health services research 
approach that will allow our team to determine the cost effectiveness of expanding the 
role of the registered dietitian on the KT team in a subsequent R01 project. Only one 
study of a lifestyle modification intervention targeting diet and exercise with KT 
recipients has been published, but it lacked a randomized controlled trial because it 
confounded intervention with health condition and studied patients who were at least 6 
months post-transplant.43 In contrast, our intervention will focus on patients when they 
are still in the hospital immediately post-transplant. Hospitalization has been 
hypothesized to serve as a "teachable moment" that could more clearly demonstrate to 
patients the connection between behavior and health and be particularly amenable to 
making changes in patient health behavior (e.g., in-patients with unhealthy alcohol use, 
diabetes, pediatrics, cancer).44-47 
The most critical innovation of the IMPACT pilot is our collaboration with the 
makers of Twistle (Fig. 1).39 Twistle is a HIPAA-compliant patient engagement 
platform designed to perform across all clinical specialties, procedures, and chronic 
conditions. Twistle is used for patient education, reminders, and secure messaging. 
Clinicians and patients can automatically send and receive HIPAA-compliant messages 
including text, emojis, photos, and videos. Twistle has an automation engine that can 
engage, respond and manage conversations, allowing staff and clinicians to take over 
conversations that need extra attention. It can also automatically send alerts and follow-
up messages based on survey responses and triage appropriately based on pre-defined 
rules and on-call schedule. Twistle is designed to integrate with electronic health records, 
registries, databases and predictive analytics tools. It also automatically synchronizes data 
from smart devices, such as blood pressure cuffs, weight scales, CPAP machines, and 
activity trackers. 
Because Twistle is 
a multimodal 
platform, it can 
deliver messages 
and reminders 
through 
smartphone apps 
(Apple and 
Android), text 
message (SMS), 
computer 
browsers, EHR 
portal and regular 
landlines using 
interactive voice 
response (IVR) or 
recorded voice. So 
our intervention 
with Twistle will be used by those with or without a smartphone, and addresses recent 

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Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology 
(IMPACT)
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and ongoing concerns regarding broadband internet and provider access in rural 
communities.48,49
For our research purposes, we will use Twistle to create and deploy our participant 
questionnaires because it is compatible with RedCap. We will also use it to send 
personalized reminders and check-in with participants based on the culturally-tailored 
exercise and diet plan developed by our intervention team to assess and maintain 
adherence to the intervention. Twistle also enables the data to be pushed to a 
reimbursement database, so that our research team is triggered to provide participant 
payments. Finally, we will use Twistle to track participant status throughout the research 
protocol. The application will allow us to confirm message delivery, patient engagement, 
and monitor triage alerts.
We will randomly assign participants to either the IMPACT intervention of usual care 
(UC) prior to their first intervention point. Dr. Zhu (lead statistician) will develop a 
random allocation scheme by considering stratification to form blocks with respect to 
important determinants such as ethnicity, gender, etc. Within each stratum or block, we 
will accomplish random allocation to IMPACT vs UC with systematic sampling (e.g. 
alternating the assignment of IMPACT and UC with a random start). This scheme will 
result in a nearly equal number of patients in IMPACT and UC within a block. We will 
reduce potential bias using stratified randomization by preventing potentially inferring 
treatment allocation a priori. It also reduces bias by balanced assignment so that potential 
determinants of outcomes are comparable across intervention groups. We can also use 
systematic sampling to reduce sampling variation in comparison with simple random 
sampling. Because of the close interaction between the clinical team and the research 
interventionists, we will not be able to blind the clinical team to group assignment.50,51 
After Dr. Zhu creates the allocation scheme, he will give it to the research coordinator, 
who will put the allocation assignments into separate sealed envelopes. The research 
coordinator will place the master list in a locked file cabinet drawer in the office of the 
PI’s Office Administrator. Only the sequence numbers (A1 – block A patient #1, A2, A3, 
etc.) will appear on the sealed envelopes and the corresponding group assignment will be 
placed inside the envelope. The research coordinator will open the sealed envelope 
sequentially and inform the consented participant of his or her assigned group. After 
random assignment, the research coordinator will direct participants in the IMPACT 
intervention to the study interventionists (the physical therapist and dietitian).
4. Inclusion and Exclusion Criteria
We plan to recruit participants shortly before or after undergoing KT at the UNM 
HSC Transplant Center. The Transplant Center provides transplant services to all 
New Mexico residents as well as the surrounding Pueblos and the Navajo Nation. 
Reflecting the demographics of the state, only 3% of patients are AA at UNM. Male 
and female KT recipients aged 18 and older will be eligible for enrollment.
Transplant Patients
Inclusion criteria:
1.
Received kidney transplant at the University of New Mexico
2.
Greater than 18 years of age

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3.
American Indian (AI) or other race, White (WH) or Hispanic/Latina(o) (HL)
4.
Mentally competent 
Exclusion criteria:
1. Children under the age of 18
2. Incarcerated patients
3. Pregnant women
Team Members
Inclusion criteria:
1. Transplant clinic staff
2. Key administrators involved in the transplant process
5. Number of Subjects
To estimate the number of patients we can expect to recruit for the study, we used 
data from the last five years of KT recipients at UNM HSC. The center transplants an 
average of 33 patients per year. For the study, we plan a 12-month recruitment period. Of 
all eligible patients who receive a KT, we expect that 80% will agree to participate in our 
study (n=26), based on previous intervention research with KT patients,13,16,17,34,41,52-54 
and our own work.55-57 Thus, for this pilot trial, we aim to recruit and retain 14-20 KT 
recipients. Virtually all of UNM ESKD patients are (a) HL (44%) or AI (33%), (b) 
income <$25K, (c) on public insurance, (d) high school or lower education; and/or, (e) 
low occupational status. Thus, our patient sample will include members of different 
vulnerable populations that have been underrepresented in past research, and hence 
prepare us to conduct a formal study in a diverse population.
Team members will include up to fifteen people from the following groups: 
transplant clinic staff and key administrators. 
6. Study Timelines
Participant expected duration in the study will be one year, if they complete all study 
visits. Patient recruitment and enrollment will be completed in 12 months of the study 
(Month 4, Year 1 through Month 3, Year 2). Participant follow-up, data analysis, and 
manuscripts are schedule to be completed in Year 2 of the study. 
Project Period: 03/01/2020 – 02/28/2022
Year:
Month:
Activity
01
1-3  4-6  7-9 10-12
02
1-3  4-6  7-9 10-12
Project Startup (e.g., hiring and training staff; database creation)
----
Participant Recruitment
         -------------------
-----

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Participant Follow-up
----------------------------
Team Member Surveys
----------------------------
Data Quality Evaluation and Observation Logging
-------------------------
----------------------------
Data Analysis
----------------------------
Present Initial Findings at Conferences
                             ----
Report and Manuscript Preparation
                             ----
7. Study Endpoints
The primary endpoints for the pilot trial are intervention acceptability and 
feasibility. To assess intervention acceptability we will measure patients’ satisfaction 
with the interventions with a revised version of the Client Satisfaction Questionnaire;58-60 
where higher satisfaction will indicate greater intervention acceptability, and the System 
Usability Scale (SUS),61 where higher scores indicate ease of usability. We will assess 
questionnaire acceptability using open-ended patient questions. In addition to quantifying 
feasibility using recruitment and retention rates, to provide concrete estimates of the 
expected rates of missing data and participant attrition, we will keep a detailed log of 
relevant factors that could create barriers to subsequent study completion. We will 
measure time spent sedentary (sitting/lying), standing, and stepping (and the intensity) 
during awake hours with the activPAL3 accelerometers, and compare these values 
between the IMPACT and UC groups. Time required for study participation will be 
measured using survey completion times as well as intervention session time estimates. 
In addition to the primary endpoints noted above, we will assess the feasibility and 
acceptability of collecting a number of patient outcomes that will be the key target 
outcomes in a large scale R01. A systematic review of 35 randomized controlled trials of 
exercise training in solid organ transplant recipients, including 9 kidney, 21 heart, 3 lung, 
and 2 liver transplant studies, found that there were a total of 62 patient outcome 
measures, including peak VO2, SF-36 score, and muscle strength.52 Of these, our team 
determined that the most relevant outcomes to assess in our pilot include: (a) variables 
that we will gather from participants’ medical records (i.e., % weight change, lipid 
profile, and HbA1c); (b) patient reported outcomes, including the PROMIS Sleep Related 
Impairment62 and Sleep Disturbance63 Measures and PROMIS Global Health64; and, (c) 
occupational functioning, using the occupation subscale of the CHART-SF.65 The 
CHART-SF is the most widely used participation measure in rehabilitation research,66 
and has been used in various ethnic groups.67 
8. Research Setting
We plan to recruit participants shortly before or after undergoing KT at the UNM 
HSC Transplant Center. The Transplant Center provides transplant services to all New 
Mexico residents as well as the surrounding Pueblos and the Navajo Nation. Reflecting 

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Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology 
(IMPACT)
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the demographics of the state, only 3% of patients are AA at UNM. Thus, their number 
will be too small to examine as a separate racial group. Male and female KT recipients 
aged 18 and older will be eligible for enrollment.
9. Resources Available
The PI and the research team bring extensive expertise to this project, and are 
well-known for their interdisciplinary work in KT. Dr. Myaskovsky has a national 
reputation in KT disparities by examining issues related to organ donation and 
transplantation.68-73 Dr. Unruh has national recognition in clinical trials and patient-
reported outcomes in chronic kidney disease74-88 and KT.71,85,89-101 Drs. Unruh and 
Myaskovsky have a long history of collaboration on longitudinal studies that encompass 
a broad range of cultural issues related to kidney donation and transplantation.102,103 Dr. 
Singh is the Medical Director of Transplant Services at the (UNMHSC). She collaborates 
with Drs. Unruh on issues related to the medical care of CKD and ESKD patients.106,108-
110 Dr. Zhu has done extensive work in developing data analytic methods and 
collaborating and supporting health and clinical research in a broad spectrum of fields.111-
114 From 2005-2011, Dr. Zhu served on the Advisory Committee on Organ 
Transplantation (ACOT) to advise the Secretary of the Department of Health and Human 
Services on national policies concerning all aspects of solid organ transplantation. He is 
also collaborating with Drs. Myaskovsky and Unruh, on adherence and healthcare 
disparities in kidney transplantation.105,106 Dr. Jimenez is an Associate Professor in the 
Department of Internal Medicine at UNM HSC, and the Director of the Nutrition 
Research Network (NRN) for the Academy of Nutrition and Dietetics. She has served as 
a Co-I or PI on studies focused on developing and testing interventions to better prevent 
and treat obesity and diabetes in high risk and underserved populations in New Mexico, 
and studies focused on testing the impact of nutrition care from a registered dietitian 
nutritionist on medical outcomes in different patient populations, including kidney 
disease.115-118 Dr. Jimenez works closely with Dr. Steiber, the Chief Science Officer the 
Academy of Nutrition and Dietetics, and an Adjunct Professor in the Department of 
Nutrition, School of Medicine at Case Western Reserve University. Dr. Steiber has 
conducted a number of studies focused on nutrition assessment for malnutrition in 
patients with CKD, and will contribute her expertise in validation and feasibility studies 
focused on nutrition and assessment117,119-121 as a consultant for our IMPACT pilot trial. 
Finally, our team’s licensed physical therapist will be an expert in evaluating, developing 
and implementing individualized, evidence-based physical therapy services to increase 
patients’ functional abilities.
Our team conducted a qualitative assessment with HL and AI patients, KT clinical 
providers, a registered dietitian and physical therapist to ensure that the IMPACT 
intervention is culturally and contextually appropriate. This work will form the basis of 
our pilot intervention. We also worked with KT clinical team to develop the timing and 
deployment of the intervention.  We developed a detailed protocol to ensure that the 
intervention is standardized across all research participants, while still responding to 
individual needs. 
We also worked closely with the Twistle team39 to personalize the research intervention, 
participant questionnaires and prompts, and participant tracking tools. We will use the 

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(IMPACT)
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personalized platform to deploy the IMPACT pilot study and we will revise it for the 
large-scale R01 trial, per findings from this pilot study.
10.Prior Approvals
UNM HSC IRB Approval will be obtained before beginning any study activities. 
Departmental Approval has been obtained and uploaded into Click IRB.
11.Multi-Site Research
NA
12.Study Procedures 
Intervention 
Intervention timing: We will minimize participant burden by applying the 
interventions during patients’ standard post-transplant clinic visits. We display how the 
intervention time points correspond to the standard clinic schedule in Figure 2. The 
transplant team schedules patients for appointments at the post-transplant clinic 1x/week 
for the first month, then every two weeks for the next two months, then once a month at 
4-6 months post-KT. Surgical clearance usually occurs 6-8 weeks post-KT, at which 
point the exercise intervention can begin. We will take advantage of these frequent in-
person visits to deploy our exercise and diet intervention. Prior to the start of the exercise 
intervention, we will include a “baseline” test. We will measure time spent sedentary 
(sitting/lying), standing, and stepping (and the intensity) during awake hours with the 
activPAL3 accelerometers. At the baseline visit for both groups, we will assess self-
reported exercise and physical functioning prior to transplant. Those in usual care will not 
undergo any diet or exercise intervention, but will wear an activity monitor. They will 
only undergo the baseline interview, and a follow-up at 6 and 12-months post-transplant. 
We will repeat the objective assessment of sedentary and physical activities at the 6 and 
12-month follow-ups for all participants.
Participants in either arm may have delayed activPal monitor assessments at any of the 
four timepoints, based on current health status and at the discretion of the PI. 
Exercise intervention: Patient-reported levels of physical activity and objective 
measures of physical fitness indicate lower levels of exercise in ESKD patients awaiting 
KT. After KT, physical activity increases, but it remains lower than in the general 
population.122-125 Based on the most recent meta-analyses/reviews of physical activity 
post-transplant,33,126,127 our approach combines instructions that are professionally-
assessed with the culturally-tailored assessment of exercise needs (Appendix A), guided 
by a therapist, and incorporate a rehabilitation approach to slowly increasing KT 
recipients’ physical activity40-42 with appropriate build-up to more intense physical 
activity until they can engage in KDOQI guideline-based exercise.128  After the initial 

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Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology 
(IMPACT)
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rehabilitation intervention, the latter set of KDOQI guideline-based target activities will 
include movements that can be performed in the home without supervision or the use of 
equipment such as abdominal curls, pushups, running in place, vertical jumps, stretching 
exercises, movement to music, study-provided therapy bands, and some basic yoga 
exercises. Each at-home session will last about 30-minutes, with the goal of engaging 
participants in continuous movement. 
Participants will be asked to wear the activPAL3, an electronic activity monitor, for 
the objective assessment of sedentary activity and physical activity.  The small, thin 
device (like a patch) will be worn on their mid-thigh (day and overnight) for 4-7 days 
after transplant stabilization, at the end of near the end of rehabilitation, at 6 months, and 
at 12 months. This is not a tracking device. The activity monitor will record general 
movement (sitting, standing, and stepping) and will enable us to get a better idea of the 
participant’s daily activity and inactivity levels (versus self-report alone). We will also 
provide participants instructions for applying and removing the monitor. The activPAL3 
monitor will be mailed to the study team after each use. After data collection, participants 
will be given the following instructions: 
Once you have completed using the ActivPAL monitor, please remember to return it to 
our office using the pre-paid mailer we provided. You can drop off the mailer at any 
post office location. Please contact the study coordinator at (505) 795-1780 if you 
have any questions.
Participants will be given safety instructions (see Exercise Instructions) related to at-
home exercise, in writing and orally, to help support their physical activity after 
transplant. The instructions will also be delivered through Twistle for intervention 
participants.
The study team will follow COVID safe practices as outlined in the related 
attachment. Additionally, if participants are transitioned to remote clinic visits per the 
transplant team and therefore not coming in-person to the hospital for their routine 
appointments in order to minimize COVID exposure, activPal monitors may be mailed. 
(see attached sample letter) 
Dietary intervention: As in most other KT centers, post-transplant usual care in our 
transplant center includes one post-transplant visit with the registered dietitian. Patients 
only see a dietitian again if they return to clinic specifically with a nutritional issue. In 
contrast, KT recipients in our IMPACT trial will see the dietitian interventionist at every 
post-transplant appointment through six months post-transplant, with follow-up at 12 
months post-txp (Figure 2). Based on dietary and nutritional guidelines from KDOQI and 
other national and international sources,128,129 we plan to have the first nutrition visit 
(including the culturally-tailored assessment of dietary needs and access, Appendix B) 
occur immediately after transplant because patients are dealing with a lot of information 
and instructions post-transplant and may otherwise lose sight of their dietary needs. Thus, 
recruiting patients and starting the intervention early post-transplant will ensure that they 

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Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology 
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perceive the importance of diet and exercise with the same seriousness as 
immunosuppression and other aspects of their post-transplant regimen. The continued 
support they receive from a registered dietitian at the additional follow-up visits will 
support dietary patterns that meet their individualized nutritional needs post-transplant 
while also helping to establish behaviors that reduce the risk of excess weight gain and 
elevated cardiometabolic risk. 
Usual care groups: All participants will continue to receive care according to 
national standards. As required, all patients will have laboratory evaluations 2-3x/per 
week during the first month post-txp with a clinic visit 1-2x/week. Between months 1 and 
3, labs will be drawn weekly or bi-weekly (depending on the stability of the patient), with 
a clinic visit every 2 weeks. In months 3-6, patients have labs drawn every 2 weeks, or 
once a month (depending on the stability of the patient), with a monthly clinic visit. 
Finally, in months 6-12, patients get labs every 1-2 months, and have a monthly clinic 
visit. However, none of these lab draws will be used for the research study.
Questionnaires: Questionnaires will be delivered via Twistle or REDcap. See Appendix 
F for Twistle Script listing all comments being used throughout the study that will be 
delivered according to the relevant questionnaire and the timeline in Fig. 2. Brief surveys 
will be conducted over the phone. 
In-Depth Interviews with Participants. We will conduct interviews with participants in 
the IMPACT condition, either in-person, over the phone or via HIPAA compliant Zoom, 
and focus on participants’ experience with the intervention and recommendations for 
improvement (Appendix D). Interviews will be recorded and transcribed for analysis. 
Periodic Survey. Periodically, the Project Coordinator will contact clinical, and 
administrative teams asking to what extent, if any, barriers and/or facilitators to the 
intervention they have observed or experienced and suggestions for change if indicated. 
We will ask the transplant team to elicit feedback on the intervention process and provide 
any feedback to the Project Coordinator. We will elicit impressions of the IMPACT 
intervention and solicit suggestions regarding optimizing the future large-scale study 
(Appendix D). The Project Coordinator also will document all observations and 
experiences in a log (Appendix E), noting the date and source of the observation. We will 
review the log during research team standing meetings, and identify need for process 
changes. We will then communicate the problems identified and planned changes to the 
research, clinical and administrative teams. We will capture this data in REDCap, either 
over the phone or via direct link, whichever is more convenient for the team member. 
Interviews conducted over the phone will be recorded and transcribed.
Types of data
In addition to the in-depth interviews and brief/periodic surveys, we will collect data 
using questionnaires and from medical records. We selected the measures (see Appendix 
C for all measures) for data collection because they (a) are widely used in organ donation 

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and/or transplantation studies, other medical populations, or both; (b) have known 
psychometric properties, including (for scaled measures) Cronbach's α's of ~.80-.92 (see 
references cited with each instrument for psychometric data); and/or (c) used in our 
previous research.
Outcomes 
1. Questionnaires
a.
PROMIS Global Health Measures
b. PROMIS Sleep Related Impairment and Sleep Disturbance Measures 
c.
Satisfaction with Intervention
d. Usability Scale for Twistle Platform
e.
Occupational functioning
2. Medical records 
a.
% weight change 
b. Lipid profile
c.
HbA1c
Predictors and Covariates
1. Questionnaires
a.
Demographics
b. Sense of Mastery
c.
Social Support
d. Kinesiophobia
e.
Diet and exercise adherence
2. Medical records
a.
Immunosuppression protocol
b. BMI
c.
Other transplant relevant medical history
13.Data Analysis
Intervention Evaluation
We will evaluate the process of implementing the IMPACT intervention using a mixed-
methods approach consistent with a Type I Hybrid Intervention/Implementation 
design.130 Using the Consolidated Framework for Implementation Research (CFIR)131 as 
a theoretical framework, we will assess barriers and facilitators to implementation to 
provide real-time feedback for the pilot and to inform the future large-scale project. This 
evaluation will be comprised of a periodic survey of research, clinical, and administrative 
staff regarding barriers and facilitators of implementation and in-depth interviews with 
participants regarding experiences with the interventions.
Quantitative Analysis Plan
Primary and ancillary analysis: We will describe our patient sample with detailed 
descriptive statistics with respect to demographics and health-related characteristics. We 

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will record and summarize missing data points during the study, attrition and its 
underlying reasons when feasible.  Our primary analysis will focus on measures of 
feasibility and acceptability as outlined in Aim 1: Examine IMPACT’s acceptability and 
feasibility in an ethnically diverse KT recipient population. We will use these analyses to 
determine endpoints, their variation, plausible intervention effect size, sample size, 
planned analyses, and accrual expectations. These analyses will guide the design of the 
subsequent study.132 We will also use these analyses, as well as those of Aim 2 to 
determine a clear rationale to support the next steps in the study process, including “go 
versus no go” decisions.132
Outcomes: Whereas our primary objective is to establish the feasibility and 
acceptability of the study intervention, we will also compare the intervention group to the 
UC group with respect to the type, frequency, and intensity of exercise, as well as diet 
structure using common statistical methods, we will also compare activity tracking data 
from both groups. For example, our analysis will answer the question: what is the 
plausible range of difference in the proportion of participants engaging in the 
recommended diet and exercise routine? What is the difference in the amount of activity 
between the two groups? Given the small sample size of this study, we do not expect 
such differences will be necessarily statistically significant, but such differences will 
inform our planned large scale R01. In our future large-scale study, we will hypothesize 
that IMPACT will result in improved exercise and diet and will lead to improvements in 
post-transplant health and quality of life. When feasible we will also estimate the range of 
plausible improvements in post-transplant health and quality of life. 
Intervention Evaluation Analysis Plan 
Survey Data: We will quantitatively analyze the survey data, categorizing comments 
as to which of the four major CFIR constructs (Intervention, Outer Setting, Inner Setting, 
Characteristics of Individuals, Process) they refer to and assessing counts and frequencies 
of comments found in each construct. Sub-analyses will include assessing responses in 
relation to respondent’s role.
Participant Interviews: The core research team will review all of the interview 
transcripts to develop an annotated provisional codebook, using qualitative analysis 
software (Dedoose)133 to support this analyses. Analysis of subsequent interviews will 
proceed iteratively as follows: two primary coders will apply existing codes and will add 
new codes to the codebook as needed. We will resolve disagreement in coding through 
consensus, and we will assess inter-rater agreement between coders will be assessed.134 
We will maintain an audit trail to track coding decisions, and we will use memos 
throughout the analysis to identify key emerging concepts. We will perform thematic 
analysis as we conduct line coding to identify key concepts, including confirmation of 
existing knowledge and identification of novel themes.
Surveys with clinical team and administrators: We will create a provisional 
codebook with the barriers and facilitators we identified in the brief surveys with key 
stakeholders. We will pay particular attention to themes that deal with overall ease of use 
of the intervention and overall satisfaction with implementation. 
14.Provisions to Monitor the Data to Ensure the Safety of Subjects

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A DSMB will be created to oversee this study. DSMB members will be composed of 
the Principal Investigator and Co-Investigators with expertise in kidney 
transplantation, clinical trials, disparities, and biostatistics, plus one independent 
reviewer (IR), who has no financial, scientific, or other conflict of interest with the 
study.  Written documentation for the IR attesting to absence of conflict of interest 
will be required. The study team will present the IR with the study protocol, informed 
consents, and reports to assess study safety and progress. In addition, the co-
investigators will explain plans for participant recruitment, accrual and retention, 
participant risk versus benefit, performance of the trial sites, confidentiality of patient 
data, monitoring of study progress and assessment of other factors that can affect 
study outcome during the DSMB meeting. 
The IR will review all data captured for the study including unanticipated events. This 
will allow the Principal Investigator and study team to assess whether more frequent 
monitoring will need to take place and how it will affect others currently enrolled. 
The IR will have the authority to recommend stopping the study early or modifying 
the study design for safety concerns. The DSMB will review the progress of the study 
within 2 weeks after the first patient is randomized into the study and will conduct 
meetings routinely thereafter until enrollment is closed. The IR will recommend 
terminating the study if the safety, welfare and health of patients is jeopardized due to 
conducting the study according to protocol. Unanticipated events will be reported by 
the study team to the IR and the IRB within 24 hours of becoming aware of the event. 
The Principal Investigator will assess the adverse event (AE)/serious adverse event 
(SAE) relationship to the IMPACT intervention. 
15.Withdrawal of Subjects
Subjects are free to withdraw from study participation at any time during this clinical 
study. The Investigator may withdraw a subject if continued participation is not in the 
interest of the subject’s health and welfare, for noncompliance with protocol-
specified procedures, or because of a protocol violation.  This will be evaluated on a 
case-by-case basis by the Investigator. All data collected from a withdrawn 
participant will be destroyed if the participant withdraws from the study at any point.
The primary reason for discontinuation or withdrawal will be documented as one of the 
following:
• Adverse Event
• Noncompliance 
• Protocol violation
16.Data Management/Confidentiality
The PI will oversee all aspects of data management in close collaboration with the 
lead study statistician, Dr. Zhu. The study team will work with the Twistle, Inc. team 
to develop an operations manual to standardize all procedures and staff training in 
areas such as patient recruitment, measurement, assessment, and data entry, 
management, and security. Following the guidelines outlined in the operations 
manual the statistical team will create an electronic data entry system using REDCap, 

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a mature, secure, and HIPAA compliant web application for building online surveys 
and databases. REDCap is supported at the University of New Mexico, and will be 
used to capture data from the study and to temporarily store the resulting research 
data. Data will be exported from REDCap and imported into SAS for data analysis. 
The statistical team will work closely with the investigative team and other study 
personnel to ensure that protocols are being followed, data integrity and 
confidentiality are maintained, and that the degree of missing data is minimized. All 
study files residing in designated network folders will be backed-up daily and 
archived weekly. The weekly data will be stored on a separate server that is 
physically located > 1 mile from the location of the servers housing the primary study 
data. The weekly archived files are maintained for 1 year until the data are erased. All 
study subjects will be assigned unique study identifiers that will appear on all data 
collection instruments, tapes, documents, and files used in the statistical analysis and 
manuscript preparation. Only authorized team members will have access to personal 
information needed for tracking and informed consent. Other data quality assurance 
measures will include detailed documentation of computer operations and data editing 
procedures and regular meetings with project staff to review any changes in 
procedure. The data team also has specific data quality measures that will be 
implemented. These include data verification, built in data validation mechanisms 
such as logic and out of range data checks, and repeated evaluation of the data 
collection and entry process.
Participant name and other identifying information will be linked to a unique study 
ID once consented.  This study ID will not display any information that can identify 
the participant.  All of the data collected from the participant, including recorded and 
transcribed interviews, will be coded using participant study ID and the link will be 
kept in a locked cabinet, and/or password protected computer files. The master list 
linking participant identifying information to participant study data will be kept in a 
separate, secure location at UNM. Only the UNM study team will have access to the 
master list.  We will keep the link between participant identifying information and 
study data until the end of the research study. This link will only be available to 
UNM, and will not be accessed by researchers at other institutions.
17.Data and Specimen Banking
NA
18.Risks to Subjects
This trial is voluntary and those undergoing KT who do not wish to participate will 
have access to usual care. We will obtain consent via a formal signed consent form. 
Patients will be provided adequate time to weigh enrolling in the trial. 
The assessors and interventionists will be sure to interview patients in a respectful 
manner, and will have enough knowledge to be able to explain what steps would be 
taken to ensure patient confidentiality. For some patients, discussing the intervention 
and their adherence to it, may be upsetting. Any patients requesting additional 
counseling will be provided with contact information for the transplant team social 

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Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology 
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worker. Participants will be reminded that they have the option of discontinuing study 
participation at any time or taking a break if the interview length feels too 
burdensome. Results from our current work indicate that the interview should be 
completed in approximately 30 minutes or less.
We expect the risks associated with the diet and exercise intervention to be minimal 
because the licensed dietitian and physical therapist on the research team will closely 
monitor the patient participants, to minimize risk. However, if the patient feels there 
is an exercise they cannot do, we will urge them to discuss their concerns with the 
physical therapist.
Clinical team and administrators’ surveys will remain anonymous. Informed consent 
will be obtained from all participating staff before the start of the first survey via 
consent letter. Data from these surveys will also be kept confidential.  
The study team will follow COVID safe practices as outlined in the related 
attachment.
19.Potential Benefits to Subjects
Benefits include: reducing the likelihood of weight gain, diabetes, and cardiovascular 
events post-transplant. Participation in the study will address the limitations of 
previous physical activity and dietary interventions in KT recipients: (1) small sample 
size, (2) short patient follow-up, and (3) limited population diversity. Finally, 
participants will benefit from knowing that they will be helping future patients and 
other transplant centers easily package and disseminate the intervention using 
Twistle, which gives them a way to tailor the intervention to the needs of their 
specific patient population and maintain regular interaction and follow-up.
20.Recruitment Methods
Flyers will be placed and brochures in the UNM HSC Transplant Center. In 
addition, potential participants will be approached shortly before or after 
undergoing KT, as they are in recovery, at the UNM HSC Transplant Center. 
All participants will continue to receive care according to national standards 
whether or not they participate in the study. All participants who are 
randomized to the IMPACT intervention will have in-depth interviews. All 
IMPACT intervention study staff, transplant clinic staff and key 
administrators involved in the transplant process will be recruited for post-
intervention surveys at the time of study initiation.
21.Provisions to Protect the Privacy Interests of Subjects
Face-to-face visits will take place at the UNM HSC Transplant Center in 
private clinic rooms. 
22.Economic Burden to Subjects

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Participants will not be charged for any research related visits. All visits will be 
scheduled during standard post-transplant clinic visits. Twistle is a free service to 
participants.
23.Compensation
We will compensate participants $20.00 for each completed visit; three visits 
for participants randomized to usual care and thirteen visits for participants 
randomized to IMPACT intervention. IMPACT intervention participants will 
be given an additional $20 for the in-depth interview at their last follow up visit. 
The payments will be issued at the completion of each visit in the form of a 
merchandise card. 
24.Compensation for Research-Related Injury
If the subject becomes sick or injured as a direct result from the study, they may receive 
emergency treatment, however, there is no commitment by the UNM HSC to cover the 
costs related to research related injuries. The subject and/or their third party payer will 
be charged in the usual way.
25.Consent Process
We will obtain consent via a formal signed consent form. All potential participants 
will be given as much time as they need for consent review prior to signing the 
consent form and will be asked to verbalize the purpose of the study as a check for 
understanding. The consent form will then be signed and dated by the participant 
before initiation of any study activity.
Subjects not fluent in English
NA
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally 
Authorized Representative
NA
Subjects who are not yet adults (infants, children, teenagers)
NA
Waiver or Alteration of Consent Process (consent will not be obtained, required 
element of consent will not be included, or one or more required elements of 
consent will be altered) 
We are requesting a partial waiver of HIPAA Authorization for 
Screening/Recruitment. Pre-screening will include the following details: 
o
Received kidney transplant at the University of New Mexico
o
Greater than 18 years of age
o
Race/ethnicity details

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26.Documentation of Consent
A copy of the signed/dated ICF will be given to the subject. A copy of the 
signed/dated consent will be placed in the subject’s research file that will be kept in a 
locked file cabinet. To document our consenting process we will be following the 
UNM HSC HRPO procedure titled, “SOP: Written Documentation of Consent (HRP-
091).”
27.Study Test Results/Incidental Findings
NA
28.Sharing Study Progress or Results with Subjects
Consented participants will not be provided with a summary of the trial progress while 
the study remains underway nor will they be provided with study results.
29.Inclusion of Vulnerable Populations
No vulnerable populations will be recruited for this study.
30.Community-Based Participatory Research
NA
31.Research Involving American Indian/Native Populations
The study involvement of American Indian populations is critical to the research 
study and we will be sensitive to community attitudes by engaging them in 
interventions that are culturally tailored. 
32.Transnational Research
NA 
33.Drugs or Devices
NA - this research does not evaluate the safety or effectiveness of a medical device
The activPAL3 activity monitoring device (worn on the thigh):
a.
This is not a device study, i.e., this study does not evaluate the efficacy or safety of 
a device. There is no information on the FDA website regarding the activPAL3 
monitor (NOTE: these monitors are from a company in Scotland, UK). However, 
these monitors are similar to the ActiGraph monitors except for the attachment 
method. The activPAL3 monitors are not investigational devices as they are 
commercially available (http://www.paltechnologies.com/); the shipment of 
activPAL3 monitors was cleared by the FDA and delivered to the Study PI. These 
monitors are the gold standard for objectively measuring sedentary behavior and 
ambulation in research study participants and have been used in many trials in the 
U.S. The activPAL3 monitors are more expensive than consumer wearable 
monitors (e.g., FitBit, Jawbone) and require special software to analyze the data, 
thus these monitors are used in research rather than being purchased by consumers. 
In this study, the monitors are used to measure outcomes (frequency, duration, and 

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intensity of free-living sedentary behavior and light physical activity), and are not 
used to diagnosis or treat disease, or to support/sustain life.
b. These monitors do not present a potential for serious risk to the health, safety, or 
welfare of the subject. There is a potential for a small risk of skin irritation due to 
the adhesive used to attach the activPAL3 to the thigh. We are minimizing this risk 
by asking the research participants to check the monitors daily and if skin irritation 
occurs, to remove the monitor and contact study staff.
To our knowledge, the FDA has not evaluated this device; however, it would likely fall 
under the same category as a similar research grade activity monitor, ActiGraph (not used 
in this study). We believe, that like the ActiGraph monitors, the activPAL3 monitors used 
in this study poses non-significant risk per the FDA definition: i) it is not an implanted 
device, ii) it is not a life sustaining/ supporting device, iii) it is not “for a use of substantial 
importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing 
impairment of human health”, and iv) it does not otherwise present “a potential for serious 
risk to the health safety, or welfare of a subject”. 
34.Principal Investigator’s Assurance
By submitting this study in the Click IRB system, the principal investigator of this study 
confirms that:
☒ The information supplied in this form and attachments are complete and correct.  
☒ The PI has read the Investigator’s Manual and will conduct this research in accordance 
with these requirements. 
 ☒ Data will be collected, maintained and archived or destroyed per HSC Data Security 
Best Practices, including:
1. Best Practice for data collection is for it to be directly entered onto a data 
collection form that is in a secured access folder on an HS drive behind a firewall, 
or in a secure UNM Data Security approved system such as RedCap.
2. Data collection of de-identified data, if done in a clinical setting or other setting 
that does not allow direct entry into a secured system, may be done temporarily 
using a personal or university owned electronic storage device or hard copy 
document. The important security safeguard is that no identifiers be include if 
the data is entered or stored using an untrusted device or storage.
3. Permanent (during data analysis, after study closure) storage must reside on 
HSC central IT managed storage. Processing of data (aggregation, etc.) are to be 
carried out in such a way as to avoid creating/retaining files on untrusted storage 
devices/computers. Trusted devices are HSC managed and provide one or more 
of following safeguards: access logs, encryption keys, backups, business 
continuity and disaster recovery capabilities.

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4. Alternate storage media must be approve by HSC IT Security as meeting or 
exceeding HSC central IT provided security safeguards.

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35.CHECKLIST SECTION
This section contains checklists to provide information on a variety of topics that require 
special determinations by the IRB.  Please complete all checklists relevant to your research.
36.Partial Waiver of Consent for Screening/Recruitment
Complete this checklist if you are requesting a partial waiver of consent so that you can review 
private information to identify potential subjects and/or determine eligibility prior to 
approaching potential subjects for consent or parental permission.
A. Describe the data source that you need to review (e.g., medical records):
N/A
B. Describe the purpose for the review (e.g., screening):
N/A.
C. Describe who will conducting the reviews (e.g., investigators, research staff):
N/A
D. Do all persons who will be conducting the reviews already have permitted access to the 
data source?
      
 Yes
            
 No. Explain:      
i. Verify that each of the following are true or provide an alternate 
justification for the underlined regulatory criteria:
1. The activity involves no more than minimal risk to the subjects 
because the records review itself is non-invasive and the results of the 
records review will not be used for any purposes other than those 
described above.
 True
 Other justification:      
2. The waiver or alteration will not adversely affect the rights and 
welfare of the subjects because eligible subjects will be approached for 
consent to participate in the research and are free to decline.  Further, 
the information accessed during the records review will not be 
disclosed to anyone without a legitimate purpose (e.g., verification of 
eligibility).
 True
 Other justification:      

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3. The research could not practicably be carried out without the waiver or 
alteration because there is no other reasonably efficient and effective 
way to identify who to approach for possible participation in the 
research.  
 True
 Other justification:      
4. Whenever appropriate, potentially eligible subjects will be presented 
with information about the research and asked to consider 
participation.  (Regulatory criteria: Whenever appropriate, the 
subjects will be provided with additional pertinent information after 
participation.)
 True
 Other justification:      
37.Partial Waiver of HIPAA Authorization for Screening/Recruitment
Complete the following additional questions/attestations if the records you will review to identify 
potential subjects and/or determine eligibility include Protected Health Information (PHI).
A. Will you be recording any PHI when conducting the records review to identify potential 
subjects and/or determine eligibility?
            
 Yes. Describe: We will be recording the patients name and age.
            
 No
B. If you answered “Yes” to question 6 above, please describe when you will destroy 
identifiers (must be the earliest opportunity consistent with the conduct of the research) 
or provide justification for why they must be retained:
Identifiers collected will be destroyed upon completion of the study and IRB closure. 
Records will not be kept for screen failures.
C. The PHI accessed or recorded for identification/screening purposes will not be reused or 
disclosed to (shared with) any other person or entity, except as required by law, for 
authorized oversight of the research study, or for other research for which the use or 
disclosure of the PHI would be permitted under the Privacy Rule.
      
 True
            
 False
38.Waiver of Documentation of Consent
A. Are you requesting a waiver of documentation of consent for some or all 
subjects?
 All
 Some. Explain:      

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B. Provide justification for one of the following:
i.
That the only record linking the subject and the research would be the 
consent document and the principal risk would be potential harm 
resulting from a breach of confidentiality. Each subject will be asked 
whether the subject wants documentation linking the subject with the 
research, and the subject's wishes will govern.
     
ii.
That the research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written consent is 
normally required outside of the research context.
All transplant team participants will be given a letter explaining this 
portion of the study. There will be no signatures required. Transplant 
clinic staff and key administrators involved in the transplant process 
will participate in these surveys, but responses to the questions will be 
anonymous. No names will appear or be used on research documents, 
or be used in presentations or publications. No more than minimal risk 
will be present. 
C. Do you intend to provide subjects with a written statement regarding the 
research in lieu of a traditional consent form?
 Yes. Please attach a copy to your submission in Click.
 No
References Cited
1.
Neale J, Smith A. Cardiovascular risk factors following renal transplant. World J 
Transplant. 2015;5(4):183-195.
2.
Rangaswami J, Mathew RO, Parasuraman R, et al. Cardiovascular disease in the kidney 
transplant recipient: epidemiology, diagnosis and management strategies. Nephrology 
Dialysis Transplantation. 2019;34(5):760-773.

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3.
Saran R, Li Y, Robinson B, et al. US Renal Data System 2014 Annual Data Report: 
Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2015;66(1 Suppl 
1):Svii, S1-305.
4.
Saran R, Robinson B, Abbott K, et al. US Renal Data System 2016 Annual Data Report: 
Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2017;69(3 Suppl 
1):A7-A8.
5.
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