Pilot Social Support Counseling Intervention for Kidney Transplant Candidates
Phase: NA
Conditions: Kidney Transplant
Sponsor: Hennepin Healthcare Research Institute

Title: A feasibility pilot study for a social support intervention in kidney transplant 
candidates 
NCT Number: NCT04363515 
Date: October 1, 2024

Attachment UUU 
 
 
 
 
Title: 
 
Drug or Device 
Name(s): 
FDA IND/IDE 
Sponsor: University of 
Minnesota Clinical and 
Translational Science 
Institute 
Protocol Date: June 15, 
2019 
Revision Date(s): Not 
applicable 
A feasibility pilot study for a social support intervention in 
kidney transplant candidates 
Not applicable 
 
 
Not applicable 
 
 
Study Principal Investigato1· (if multicenter study): Allyson Hart, MD, MS 
701 Park Ave, Nephrology Suite S5 
Minneapolis, MN, 55415 
Phone 612-873-6987 
email: hartl044@umn.edu 
Site Principal Investigator: Allyson Hart, MD, MS 
Hennepin Healthcare 
701 Park Ave, Nephrology Suite S5 
Minneapolis, MN, 55415 
Phone 612-873-6987 
email: allyson.hart@hcmed.org 
Other Investigators: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Template version: March 27, 2019 
Template adapted from: Children's Hospital of Philadelphia Research Institute 

PROTOCOL SYNOPSIS 
 
Study Title 
 Development of a social support intervention for kidney transplant 
candidates 
 
Funder 
University of Minnesota WERC award 
 
Clinical Phase 
Not applicable 
 
Study Rationale 
 Intensive home-based group counseling with a psychologist are the 
only interventions that have been shown to increase rates of living 
kidney donation however, they are not feasible for transplant 
centers. A recent review on strategies to increase living kidney 
donation concluded that strategies directed at candidates and their 
social supp01t networks are the most promising based on the data 
available. Therefore, we propose an intervention that incorporates 
individualized risk communication into group counseling with 
patients and their support networks at the transplant center. 
 
Study Objective(s) 
Primary 
• 
To determine whether counseling with the shared decision aid, 
provided in the clinical setting to candidates along with 
members of their social suppo1t network, increases pursuit of 
transplant. 
Secondary 
• 
To determine whether the intervention influences patient 
knowledge about kidney transplant, decisional conflict, and 
hope. 
• 
To determine if the intervention influences social suppo1t group 
knowledge about kidney transplant and intention/motivation to 
support the patient through the transplant process. 
Test Article(s) 
(If Applicable) 
Not applicable 
 
 
Study Design 
Pilot randomized control trial 
 
 
Subject Population 
Key Criteria for 
Inclusion and Exclusion: 
Inclusion criteria include adult kidney transplant candidates at the 
University of Minnesota or Hennepin County Medical Center. 
Exclusion criteria include inability to consent, non-English 
speaking, or candidates for combined organ transplant. 
 
 
Number Of Subjects 
Total Number of Subjects: 60 
Total Number of Sites: 2 
 
Study Duration 
Each subject's participation will last 3 months. 
The entire study is expected to last through November 1st 2020. 
 
Study Phases 
(1) Screening: screening for eligibility and obtaining consent 
 

Screening 
Intervention 
Follow-Up 
(2) Intervention: group counseling session 
 
Efficacy Evaluations 
Primary evaluation measurements that will be used to assess the 
efficacy of the intervention 
Pharmacokinetic 
Evaluations 
Not applicable 
 
 
Safety Evaluations 
Not applicable 
Statistical And Analytic 
Plan 
 
 
Data And Safety 
Monitoring Plan 
A Student's T-test will compare means for the primaiy outcome of 
the number of inquiries per candidate (primary outcome). Chi­ 
squai·ed and Student's T-tests will be used to compare secondary 
outcomes. 
The principle investigator is responsible for data quality 
management and ongoing assessment of safety. 
 
 

page1v 
 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES 
 
Study Phase 
Screening 
Treatment/Intervention 
Follow-up 
Visit Number 
1 
2 
NIA 
Informed Consent/Assent 
X 
Review Inclusion/Exclusion 
Criteria 
X 
Bassline Survey to measure 
secondru.y outcomes 
X 
Demographics/Medical 
Histo1y 
X 
Randomization 
X 
Inte1vention (group 
counselling session) 
X 
Survey to measure secondru.y 
outcomes 
X 
Assess primru.y outcome 
through medical records 
X 

1 
 
 
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 
Name and Description of Investigational Product or Intervention 
We will conduct a pilot randomized trial to compare group counseling with transplant 
candidates and their suppo1t networks that incorporates the shared decision aid with a risk 
calculator, versus usual pre-transplant care. 
 
1.2 
Findings from Non-Clinical and Clinical Studies 
Not applicable 
1.2.1 Non-Clinical Studies 
Not applicable 
1.2.2 Clinical Studies 
1.2.2.1 Human Pharmacokinetics 
Not applicable 
1.2.2.2 Clinical Studies in Adults 
 
 
1.2.2.3 Clinical Studies in Children 
 
 
1.3 
Selection of Drugs and Dosages 
Not applicable 
1.4 
Relevant References 
1.5 
Compliance Statement 
This study will be conducted in full accordance of all applicable Hennepin Healthcare 
Research Policies and Procedures and all applicable Federal and State laws and regulations. 
All episodes of noncompliance will be documented and repo1ted according to the Prompt 
Repo1ting Guidelines, Attachment EEE, of the Hennepin Healthcare IRB Policies and 
Procedures. 
The investigators will perfonn the study in accordance with this protocol, will obtain 
consent, unless waiver of consent or other alteration is approved, and will repo1t 
unanticipated problems involving risks to subjects or others and SAEs in accordance with 
The Hennepin Healthcare IRB Policies and Procedures and all Federal requirements. 
Collection, recording, and rep01ting of data will be accurate and will ensure the privacy, 
health, and welfare of research subjects during and after the study. 

2 
 
 
2 
STUDY OBJECTIVES 
The pmpose of the study is to detennine whether counseling with the shared decision aid, 
provided in the clinical setting to candidates along with members of their social suppo11 
network, increases pursuit of transplant. 
2.1 
Primary Objective (or Aim) 
The primary objective of this study is to detennine whether counseling with the shared 
decision aid, provided in the clinical setting to candidates along with members of their social 
suppo1t network, increases pursuit of transplant. 
 
2.2 
Secondary Objectives (or Aim) 
The secondaiy objectives are to: 
• 
Determine whether the intervention influences patient knowledge about kidney 
transplant, decreases decisional conflict, and hope. 
• 
Detemline if the intervention influences social suppo1t group knowledge about 
kidney transplant and intention/motivation to suppo1t the patient through the 
transplant process. 
 
3 
INVESTIGATIONAL PLAN 
3.1 
General Schema of Study Design 
3.1.1 Screening Phase and Baseline Assessment 
Potential subjects will be screened using the protocol inclusion and exclusion criteria. 
Potential subjects will be reached out to over the phone before their initial appointment at 
the clinic to see if they express interest in hearing more about the intervention. Those whom 
want to learn more about the intervention will then be met with during their first kidney 
transplant counseling appointment at the transplant clinic. Permission (info1med consent) 
will be obtained during this appointment, if the patient would like the participate in the 
intervention. After the patient has completed the health assessment phase and is officially a 
candidate for transplant, they will be emolled in the study. 
3.1.2 Study Intervention 
Participants in the intervention group first undergo usual pre-transplant counseling, and will 
then undergo a group counseling session with members of their suppmt network at the 
transplant center. The session will include 1) a description of general options for treatment 
of end stage kidney disease, 2) the likely outcome of each of those options specific to the 
transplant candidate utilizing the decision aid, 3) a presentation of common reasons to 
pursue or not pursue each of those options (including common barriers to living donation), 
and 4) a discussion of how the suppo1t network can be involved in the transplant process. 
Tllis discussion will be info1med by focus groups conducted in a previous study. 

3 
 
 
The group counseling session will follow a general script and will be facilitated by the 
principal investigator or a trained transplant educator, with recording and random review of 
the sessions to ensure quality and consistency of the content. Printed results of the decision 
aid output will be shared with the clinical transplant team to replicate clinical practice. 
 
The control group will undergo the usual pre-transplant counseling and clinical evaluation 
conducted by the transplant center team. The control group will be info1med about the 
availability of the online shared decision aid by a member of the research team. 
 
3.1.3 Part 2 (Use an appropriate descriptor such as "Open-Label Treatment") 
Not applicable 
3.1.4 Follow-up 
Not applicable 
3.2 
Allocation to Groups and Blinding 
The enrolled study participants will be randomized via computer into either the intervention 
or control group. Pa1ticipant and researcher blinding is not feasible for the intervention, but 
asce1tainment and statistical analysis of outcomes will be performed by an analyst blinded to 
group assignment. 
3.3 Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
The study duration per subject will be up to 3 months. There will be one day of screening 
and one day that the inte1vention takes place. The remainder of the time is allotted for 
patients to undergo standard pre-transplant care and counseling. 
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at two investigative sites in the United States. 
Recruitment will stop when approximately 60 subjects are consented (7 patients in the 
control group + 8 patients + 6-7 friends and family each in the inte1vention group). 
3.4 Study Population 
3.4.1 Use of Vulnerable Populations and Patients Who Opt Out of Research 
Vulnerable populations and patients who opt out will not be included in the study. 
3.5 Inclusion and Exclusion Criteria 
3.5.1 Inclusion Criteria 
l) Adult males or females. 
2) Kidney transplant candidates. 

4 
 
 
3) Additional criteria as required. 
3.5.2 Exclusion Criteria 
1) Non-English speaking individuals. 
2) Individuals with impaired ability to consent. 
3) Candidates for combined organ tTansplant. 
4) Patients who choose to opt out of research. 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations 
of these criteria must be repo1ted in accordance with IRB Policies and Procedmes. 
4 
STUDY PROCEDURES 
4.1 
Screening Visit and Baseline Assessment 
• 
lnfo1med Consent 
 
• 
Medical Record Review 
4.2 
Study Intervention 
4.2.1 Visit 1 
• 
Demographic survey 
 
• 
Evaluative survey 
4.2.2 Visit 2 and Visit 3 
Not applicable 
 
 
4.3 
Part 2 of the Study (e.g. Open-Label Treatment) 
Not applicable 
4.3.1 Visit 4 
Not applicable 
4.3.2 Visit 5 
Not applicable 
4.4 
Follow-up 
• 
Medical records 

5 
 
 
4.4.1 Visit 6 
Not applicable 
4.4.2 Visit 6: End of Study 
Not applicable 
4.5 
Unscheduled Visits 
Not applicable 
4.6 
Concomitant Medication 
Not applicable 
4.7 
Rescue Medication Administration 
Not applicable 
4.8 
Subject Completion/Withdrawal 
Participants may withdraw from the study any time without prejudice of their care. The 
infmmed consent document stipulates that we will retain data collected prior to study 
withdrawal. Pa1tial withdrawal (no further active paiticipation but with ongoing data 
collection after withdrawal from health record) will be requested if a participant wishes to 
cease pa1ticipation, as per the informed consent document. 
4.8.1 Early Termination Study Visit 
Subject's data from after withdrawal from the study will be not be used. 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
• 
Informed Consent: infmmed consent will be used to infmm patients about the 
inte1vention and their rights if they choose to participate. 
• 
 Medical Record Review: medical records will be reviewed to ensure that patients 
meet inclusion/exclusion criteria for intervention. They will also be used during 
follow-up to assess our primary outcome variable, to determine if the patient 
engaged in pursuit of transplant. 
 
• 
 Demographic survey (see appendix): This survey will be used to understand the 
population participating in the intervention. 
• 
 Evaluative survey (see appendix): This survey will assess our secondary outcome 
measures, to determine whether the intervention influences patient knowledge about 
kidney transplant, decisional conflict, and hope. Also, to determine if the 
intervention influences social support group knowledge about kidney transplant and 
intention/motivation to suppmt the patient through the transplant process. 

6 
 
 
5.1 
Screening and Monitoring Evaluations and Measurements 
5.1.1 Medical Record Review and demographics questionnaire 
• 
Race 
 
• 
Ethnicity 
 
• 
Household income 
 
• 
Education level 
 
• 
Blood type 
 
• 
Calculated panel reactive antibody age 
 
• 
Time on dialysis 
 
• 
Diabetes 
 
• 
Gender 
 
• 
BMI 
• 
Cause of kidney failure 
 
• 
Comorbidities (hypertension, cerebrovascular disease, peripheral vascular disease, 
and malignancy) 
5.1.2 Physical Examination 
Not applicable 
5.1.3 Vital Signs 
Not applicable 
5.1.4 Laboratory Evaluations 
Not applicable 
5.1.4.l 
Hematology 
Not applicable 
5.1.5 Other Evaluations, Measures 
Not applicable 
5.2 
Efficacy Evaluations 
Baseline and outcome evaluations will be used to test for intervention efficacy. These 
measures will include: pursuit of transplant, patient knowledge about kidney transplant, 

7 
 
 
patient decisional conflict, patient hope, social support group knowledge about kidney 
transplant and social support group intention/motivation to support the patient through the 
transplant process. A process evaluation will be conducted to ensme the intervention is 
implemented with fidelity and to assess what worked and did not work dming the 
implementation process. 
5.2.1 Diagnostic Tests, Scales, Measures, etc. 
Baseline evaluations will be administered before pruticipation in the intervention. After the 
intervention is complete, the outcome evaluation smvey will be administered. These smveys 
will have the same questions and measurements (listed above) in order to test for 
intervention efficacy/effectiveness. 
5.3 
Pharmacokinetic Evaluation 
Not applicable 
5.4 
Safety Evaluation 
Subject safety will be monitored by the principle investigator. 
6 
STATISTICAL CONSIDERATIONS 
The sample size (n=60) will be sufficient for conducting statistical analysis of the 
intervention. A Student's T-test will compare means for the prima1y outcome of the number 
of inquiries per candidate. Both a Chi-squared and Student's T-tests will be used to compare 
seconda1y outcomes. 
 
6.1 
Primary Endpoint 
Prima1y endpoint: pursuit of transplant 
6.2 
Secondary Endpoints 
Secondaty endpoints: patient knowledge about kidney transplant, decisional conflict, and 
hope. Also, social suppo11 group knowledge about kidney transplant and 
intention/motivation to suppo1t the patient through the transplant process 
 
6.3 
Statistical Methods 
A Student's T-test will compare means for the prima1y outcome of the number of inquiries 
per candidate between and within the intervention and control groups. Both a Chi-squared 
and Student's T-tests will be used to compare secondruy outcomes between and within the 
intervention and control groups. This is a feasibility pilot study; therefore, it is not powered 
to test anything. We will be collecting data that we could adjust for (i.e. demographics), but 
we will not be adjusting, because the main goal of this particulru· study is to gauge if the 
intervention is feasible. 

8 
 
 
6.3.1 Baseline Data 
Baseline and demographic characteristics will be summarized by standard descriptive 
summaries (e.g. means and standard deviations for continuous variables such as age and 
percentages for categorical variables such as gender). 
6.3.2 Efficacy Analysis 
The prima1y efficacy endpoint will be the change in pursuit of transplant between the 
baseline and the outcome evaluation. Secondary endpoints will include the change in 
patient knowledge about kidney transplant, patient decisional conflict, patient hope, social 
supp01t group knowledge about kidney transplant and social support group 
intention/motivation to support the patient through the transplant process between the 
baseline and outcome evaluation. All measurements will be compared with the control/no 
treatment group measurements. 
6.3.3 Pharmacokinetic Analysis 
Not applicable 
6.3.4 Safety Analysis 
Not applicable 
6.4 
Sample Size and Power 
The sample size will be n=60, with 30 patients consented from each site. This is a feasibility 
pilot study; therefore, it is not powered to test anything. 
6.5 
Interim Analysis 
Not applicable. 
7 
STUDY MEDICATION (DRUG, DEVICE, OR OTHER STUDY 
INTERVENTION) 
 
7.1 Description 
 
7.1.1 Packaging 
 
Not applicable 
 
7.1.2 Labeling 
 
Not applicable 
 
7.1.3 Dosing 
 
Not applicable 
 
7.1.4 Treatment Compliance and Adherence 

9 
 
 
Not applicable 
 
7.1.5 Drug Accountability 
 
Not applicable 
 
8 SAFETY MANAGEMENT 
8.1 Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study by the principal 
investigator. 
8.2 Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be repo1ted to the IRB in 
accordance with IRB Attachment GGG: Unanticipated Problems Involving Risks to 
Subjects or Others. AEs that are not serious but that are notable and could involve 1isks to 
subjects will be summarized and submitted to the IRB at the time of continuing review. 
8.3 Definition of an Adverse Event 
An adverse event is any untoward medical occmTence in a subject receiving a test a1ticle and 
which the occmTence does not necessarily have a causal relationship with the treatment. An 
adverse event can therefore be any unfavorable and unintended sign (including an abn01mal 
laborato1y finding), symptom, or disease temporally associated with the use of the test 
a1ticle, whether or not related to the product. 
All AEs (including SAEs) will be noted in the study records and on the case report f01m 
with a full description including the natme, date and time of onset, dete1mination of non­ 
serious versus serious, intensity (mild, moderate, severe), duration, causality, and outcome 
of the event. 
8.4 Definition of a Serious Adverse Event (SAE) 
An SAE is any untoward medical occunence that 
• results in death, 
• is life-threatening, 
• requires inpatient hospitalization or prolongation of existing hospitalization, 
• results in a persistent or significant disability/incapacity, or 
• is a congenital anomaly/bi1th defect. 

 
8.4.1 Relationship of SAE to study drug or other intervention 
It is unlikely that there will be any SAEs in relation to the intervention, as the inte1vention is 
a social suppo1t inte1vention. 
8.5 IRB/IEC Notification of SAEs and Other Unanticipated Problems 
The Investigator will promptly notify the IRB of all internal (occmring in subjects enrolled 
at this site) unanticipated problems involving risks to subjects or others, and Serious 
Adverse Events that are related to the research activity. Rep01ts will be submitted to the IRB 
in accordance with the timeline below. External (at other sites) SAEs that are both 
unexpected and related to the study intervention will be reported promptly. 
 
Category of Prompt Report 
Initial Notification 
Internal (occmring in subjects enrolled at this 
site), related (or more likely related than 
unrelated) SAE 
5 days 
Internal, unrelated SAE 
30 days 
External SAE and AEs need not be repo1ted 
unless it represents an unanticipated problem 
A brief summaiy of impo1tant AEs may be 
repo1ted at time of continuing review 
Unanticipated Problems Involving Risks to 
Subjects or Others 
5 days 
8.5.1 Follow-up report 
If an SAE has not resolved at the time of the initial repolt and new info1mation ai·ises that 
changes the investigator's assessment of the event, a follow-up repo1t including all relevant 
new or reassessed info1mation (e.g., concomitant medication, medical histo1y) should be 
submitted to the IRB. The investigator is responsible for ensuring that all SAE ai·e followed 
until either resolved or stable. 
8.6 Investigator Reporting of a Serious Adverse Event to Sponsor 
Not applicable 
8.7 Medical Emergencies 
Not applicable 
9 STUDY ADMINISTRATION 
9.1 TREATMENT ASSIGNMENT METHODS 
9.1.1 Randomization or Other Assignment 
Randomization will be computer generated and stratified by site. 

11 
 
 
9.1.2 Blinding 
Blinding is not feasible due to the nature of the intervention. 
9.1.3 Unblinding 
fu the case of a SAE the PI will be unblinded. 
9.2 Data Collection and Management 
We will keep a master list containing all PHI and subject ID numbers separate from data 
fo1ms that have only a study ID number. The master list will be in a locked file cabinet. 
We will keep a copy of all data on REDCap, a password protected electronic database 
which meets Health fusurance Po1tability and Accountability Act (HIPAA) and 
University security requirements, with the original paper copy locked in a cabinet. 
9.3 Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
fustitutional policies and HIPAA on subject privacy and that the fuvestigator and other site 
personnel will not use such data and records for any purpose other than conducting the 
study. 
Data will be stored in REDCap, a password protected electronic database which meets 
Health Insurance Po1tability and Accountability Act (HIPAA) and University secmity 
requirements. The original consent fo1m, HIPAA authorizations and any wlitten study 
c01Tespondence will be kept in a locked cabinet in the secured office suite. Only the signed 
consent fo1m will include patient name, phone number, address and EHR number; all other 
data stored separately will be linked by a de-identifiable number. A scanned copy of the 
consent f01m will be placed in the pa1ticipant's EHR. All members of the research team 
who have access to the data will have completed required Good Clinical Practice and 
Human Research Protections for Biomedical Study Teams and any other IRB mandated 
training. 
No identifiable data will be used for future study without first obtaining IRB approval. The 
investigator will obtain a data use agreement between the provider (the Pl) of the data and 
any recipient researchers (including others at Hennepin Healthcare) before sharing a limited 
dataset (PHI limited to dates and zip codes). 
Risk of breach of confidentiality will be minimal as all data will be linked to a unique 
numerical ID which does not contain any personally identifiable health info1mation. No 
personally identifiable health info1mation will be collected for this study. fu the event of a 
breach of confidentiality, pa1ticipants will be notified and corrective actions will be taken as 
approp1iate. The IRB will be promptly notified of any confidentiality breaches. 
 
 
9.4 Regulatory and Ethical Considerations 

12 
 
 
9.4.1 Data and Safety Monitoring Plan 
The principle investigator will provide oversight of the data and safety monitoring plan. All 
data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy and that the investigator and other site 
personnel will not use such data and records for any purpose other than conducting the 
study. All data will be stored in REDCap, a password protected electronic database which 
meets Health Insurance Portability and Accountability Act (HIPAA) and University security 
requirements. We will keep a master list containing all PHI and subject ID numbers separate 
from data forms that have only a study ID number. The master list will be in a locked file 
cabinet. No identifiable data will be used for future study without first obtaining IRB 
approval. 
9.4.2 Risk Assessment 
The discussions about mmiality and removal from the transplant list have the potential to 
cause emotional distress to participants. This possibility would be explained during the 
informed consent process, and candidates who would not want information about potential 
waiting list outcomes would not be included. The risk of loss of confidentiality is also 
present with procedures outlined as above to keep all study material de-identified and 
confidential. Overall, these risks are minimal with ve1y low likelihood of causing significant 
harm. 
Risk of breach of confidentiality will be minimal as all data will be linked to a unique 
numerical ID which does not contain any personally identifiable health information. No 
personally identifiable health infonnation will be collected for this study. In the event of a 
breach of confidentiality, pa1ticipants will be notified and corrective actions will be taken as 
appropriate. The IRB will be promptly notified of any confidentiality breaches. 
 
9.4.3 Potential Benefits of Trial Participation 
The intervention has the potential to change the par·adigm of pre-transplant counseling. This 
would help to better info1m patients and their suppmt networks to make critical decisions 
smrnunding kidney transplantation. 
9.4.4 Risk-Benefit Assessment 
The benefits of the study outweigh the risks. As precautions will still be taken to minimize 
risks, the potential benefits offer an opportunity to help educate patients and their families 
about kidney transplant. Furthermore, the intervention is designed to assist patients in 
making critical decisions regarding their care, while engaging their social support group. 
9.5 Recruitment Strategy 
Patients will be selected from transplant centers at HCMC and the University of Minnesota 
based on the inclusion and exclusion criteria. We will identify prospective subjects through 
their kidney transplantation counseling appointment. The subjects will likely be composed 
of both the principle investigator's patients and other provider's patients. 

13 
 
 
Eligible patients will be called prior to their transplant eligibility screening appointment and 
asked if they would be interested in hearing more about the intervention at their 
appointment. If the patient is interested, informed consent will be obtained by a study 
member during their initial screening appointment at the clinic. The intervention will only 
begin after patients have gone through the screening process and been identified as 
candidates for kidney transplant. 
9.6 Informed Consent/Assent and IDPAA Authorization 
Informed consent will be obtained by members of the study. The consent process will be 
documented in writing with the long form of consent documentation. Patients will be called 
prior to their transplant elgibility screening appointment and asked if they would be 
interested in hearing more about the intervention. If the patient is interested, informed 
consent will be obtained during their appointment at the clinic. Members of the study team 
will obtain concent. Patients will give concent for intervention participation. 
We will read the consent document with the participant, beginning with a concise and 
focused presentation of key info1mation to assist the subject to understand the reasons why 
one might or might not want to pa1ticipate in the research. We will explain the details in 
such a way that the participant understands what it would be like to take part in the research 
study. The intervention will only begin after patients have gone through the screening 
process and been identified as candidates for kidney transplant, weeks after informed 
concent is obtained. 
9.6.1 Waiver of Consent 
Not applicable 
9.6.2 Waiver of Assent 
Not applicable 
9.6.3 Waiver of HIPAA Authorization 
Not applicable 
9.7 Payment to Subjects/Families 
Not applicable 
9.7.1 Reimbursement for travel, pat'king, and meals 
Not applicable 
9.7.2 Payments to parent for time and inconvenience (i.e. compensation) 
Not applicable 
9.7.3 Payments to subject for time, effort, and inconvenience (i.e. compensation) 
Subjects will be given a $40 Target gift card at time of participation or $40 check mailed 
within 30 days after participation in the inte1vention. 

14 
 
 
9.7.4 Gifts 
Not applicable 
10 REFERENCES 
11 APPENDIX 
Baseline and Outcome Evaluations 
Patient Survey 
 
1. A patient on dialysis has the same level of kidney functioning as a patient with a 
transplanted kidney. 
D True 
D False 
D Don't know 
 
 
 
 
2. fu general, patients can live at least 5 years longer with a kidney transplant than if 
they stayed on dialysis. 
D Tme 
D False 
D Don't know 
 
3. fu general, most people on dialysis are happier with the quality of their lives than 
people with transplants. 
D Tme 
D False 
D Don't know 
 
 
 
 
4.  Patient have better health outcomes if they receive a transplant before starting 
dialysis. 
D Tme 
D False 
D Don't know 

15 
 
 
 
 
5. If a patient waits long enough on the waitlist, a matching kidney from someone who 
has died will definitely become available. 
D Trne 
D False 
D Don't know 
 
 
 
 
6. About what percentage of all transplanted kidneys function for at least one year? 
0 50% 
0 75% 
0 90% 
D Don't know 
 
 
 
 
7.  Nationally, how long do patients generally wait on the wait list for a kidney from 
someone who has died? 
D <1 year 
D 1-2 years 
D 3-5 years 
D >5 years 
D Don't know 
 
 
 
 
8. Compared to transplants from donors who have died, how long do transplants from 
living donors last? 
D Shorter 
D Longer 
D Same 
D Don't know 

16 
 
 
 
 
9. What is the chance that a living donor or recipient would dies undergoing surge1y? 
□<1% 
□ 3% 
0 10% 
0 25% 
D Don't know 
 
 
10. Do you feel SURE about the best choice for you? 
D Yes 
ONo 
 
11. Do you know the benefits and risks for getting a kidney transplant? 
D Yes 
□No 
 
12. Are you clear about which benefits and risks matter most to you? 
D Yes 
□No 
 
 
 
 
13. Do you have enough suppo1t and advice to make a choice? 
D Yes 
□No 
 
 
14. I have a positive outlook toward life. 
D Strongly agree 
D Agree 
0 Disagree 
D Strongly disagree 

17 
 
 
 
 
15. I have sh01t and/or long-range goals. 
D Strongly agree 
D Agree 
D Disagree 
D Strongly disagree 
 
 
16. I feel all alone. 
D Strongly agree 
D Agree 
D Disagree 
D Strongly disagree 
 
 
 
 
17. I can see possibilities in the midst of difficulties. 
D Strongly agree 
D Agree 
D Disagree 
D Strongly disagree 
 
 
18. I have faith that gives me comfort. 
D Strongly agree 
D Agree 
D Disagree 
D Strongly disagree 
 
 
19. I feel scared about my future. 
D Strongly agree 
0 Agree 
D Disagree 

18 
 
 
D Strongly disagree 
 
 
 
 
20. I can recall happy/joyful times. 
D Strongly agree 
D Agree 
D Disagree 
D Strongly disagree 
 
 
21. I have a deep inner strength. 
D Strongly agree 
D Agree 
D Disagree 
D Strongly disagree 
 
 
 
 
22. I an1able to give and receive caring/love. 
D Strongly agree 
D Agree 
D Disagree 
D Strongly disagree 
 
 
23. I have a sense of direction. 
D Strongly agree 
D Agree 
D Disagree 
D Strongly disagree 
 
 
24. I believe that each day has potential. 
D Strongly agree 

19 
 
 
D Agree 
D Disagree 
D Strongly disagree 
 
 
25. I feel my life has value and wo1ih. 
D Strongly agree 
D Agree 
D Disagree 
D Strongly disagree 
 
 
26. How confident are you filling out medical f01ms by yourself? 
D Extremely 
D Quite a bit 
D Somewhat 
0 A little bit 
D Not at all 

20 
 
 
Family Survey 
1. A patient on dialysis has the same level of kidney functioning as a patient with a 
transplanted kidney. 
D Trne 
D False 
D Don't know 
 
 
 
 
2. In general, patients can live at least 5 years longer with a kidney transplant than if 
they stayed on dialysis. 
D Trne 
D False 
D Don't know 
 
3. In general, most people on dialysis are happier with the quality of their lives than 
people with transplants. 
D Trne 
D False 
D Don't know 
 
 
 
 
4.  Patient have better health outcomes if they receive a transplant before sta1iing 
dialysis. 
D True 
D False 
D Don't know 
 
 
5. If a patient waits long enough on the waitlist, a matching kidney from someone who 
has died will definitely become available. 
D Trne 
D False 
D Don't know 

21 
 
 
 
 
6. About what percentage of all transplanted kidneys function for at least one year? 
0 50% 
0 75% 
0 90% 
D Don't know 
 
 
 
 
7.  Nationally, how long do patients generally wait on the wait list for a kidney from 
someone who has died? 
D <1 year 
D 1-2 years 
D 3-5 years 
D >5 years 
D Don't know 
 
 
 
 
8. Compared to transplants from donors who have died, how long do transplants from 
living donors last? 
D Sh01ter 
D Longer 
D Same 
D Don't know 
 
 
 
 
9. What is the chance that a living donor or recipient would dies undergoing surgery? 
□<1% 
□ 3% 
□ 10% 
0 25% 
D Don't know 

22 
 
 
 
 
10. I am confident that I could deal efficiently with unexpected events. 
D Never 
D Ahnost never 
D Sometimes 
D Fairly often 
D Ve1yoften 
 
11. I intend to help my friend or family member get through the transplant process. 
D Strongly agree 
D Agree 
D Neither agree nor disagree 
D Disagree 
D Strongly disagree 
 
 
 
 
12. A.re you seriously thinking about helping my friend or family member get through 
the transplant process? 
D Yes 
□No 
 
 
13. How confident are you filling out medical forms by yourself? 
D Extremely 
D Quite a bit 
D Somewhat 
0 A little bit 
D Not at all