Does a Pre-transplant Health Coaching Intervention for Informal Caregivers of Adult Heart or Lung Transplant Candidates Improve Caregiver-Reported Outcomes?
Phase: NA
Conditions: Stress, Psychological, Caregiver Burden
Sponsor: Mayo Clinic

 
 
Does a Pre-transplant Health Coaching 
Intervention for Informal Caregivers of Adult 
Heart or Lung Transplant Candidates Improve 
Caregiver-Reported Outcomes?   
 
NCT04245228 
 
February 20, 2020 

Minimal Risk Protocol Template [IRB 10429.010] 
 
Effective: 9/20/2017 
 
 
 
 
 
 
 
 
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IRB Minimal Risk Protocol Template  
 
General Study Information 
 
Principal Investigator:  Cassie Kennedy, MD       
 
 
 
 
 
 
 
 
Study Title:  Wellness Coaching for Caregivers of Thoracic Transplant Candidates   
 
Protocol version number and date:  Version 2 – February 20, 2020 
 
Research Question and Aims 
 
Hypotheses:  Caregivers will have traits and behaviors pre-transplant that will predict caregiver readiness, 
quality of life, and transplant recipient outcomes. Specifically, thoracic pre-transplant caregivers report stress, 
symptoms of anxiety or depression, and perceive high caregiver burden. These factors may be amenable to pre-
transplant intervention to improve overall patient and caregiver outcomes. 
 
Aims, purpose, or objectives:  We will conduct a pilot trial to test whether caregivers of heart and lung 
transplant candidates who receive wellness coaching will experience improvement in caregiver-related distress. 
We will also explore the relationship between caregiving and factors such as uncertainty, resilience, stress level, 
and affect. 
 
Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.): Heart and lung 
transplant recipients experience a range of psychosocial and medical issues for the duration of the transplant 
experience, including the initiation of the transplant evaluation, pre-transplant waiting period, perioperative 
recovery, and long-term adjustment post-transplant. Throughout the process, family caregivers play a major role 
in maintaining their loved ones’ physical and mental health but also undergo exposure to the stressors of 
Note: If this study establishes a human specimen repository (biobank) for research 
purposes, do not use this template. Use the Mayo Clinic Human Specimen Repository 
Protocol Template found on the IRB home page under Forms and Procedures at 
http://intranet.mayo.edu/charlie/irb/ 
 
First-time Use: Use this template to describe your study for a new IRB submission. 
1. Complete the questions that apply to your study. 
2. Save an electronic copy of this protocol for future revisions.    
3. When completing your IRBe application, you will be asked to upload this document to the protocol 
section. 
Modification:  To modify this document after your study has been approved: 
1. Open your study in IRBe. Click on the study ‘Documents’ tab and select the most recent version of the 
protocol. Save it to your files. 
2. Open the saved document and activate “Track Changes”.  
3. Revise the protocol template to reflect the modification points , save the template to your files 
4. Create an IRBe Modification for the study and upload the revised protocol template. 

Minimal Risk Protocol Template [IRB 10429.010] 
 
Effective: 9/20/2017 
 
 
 
 
 
 
 
 
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transplantation. Current evidence describes high stress, caregiver burden, and increased mood disorders in the 
pre-transplant caregiver journey. Currently, limited resources and interventions have been trialed in thoracic 
transplant caregivers to improve this distress. 
 
 
Study Design and Methods 
 
Methods:  Describe in lay terms, completely detailing the research activities that will be conducted by Mayo 
Clinic staff under this protocol. 
 
This is a pilot study examining the effects of a health coaching intervention on the stress and burden of 
caregivers of patients awaiting heart or lung transplant. 
 
Identifying Caregivers for Participation 
 
Potentially eligible caregivers for Mayo Clinic waitlisted adult heart, heart-lung, or lung transplant 
candidates (including names, address, and phone numbers of caregivers) will be acquired through the electronic 
medical record of the Mayo Clinic adult heart and lung transplant waitlisted patients. For waitlisted heart and 
lung transplant candidates without a caregiver specified in the medical record (including patients deferred, 
active, or with a waiting list status of “temporarily inactive”), they will be sent via mail, PTRAX or Redcap an 
IRB-approved contact letter including information about this study as well as a caregiver nomination form and a 
HIPAA form. Patients will have the opportunity to nominate up to 3 caregivers for participation in this study, or 
they may decline to nominate any caregivers. Non-responders will be contacted by phone to ask for caregiver 
nominations. 
 
In addition, self-referral or word-of-mouth caregiver referrals would be considered if they otherwise met 
eligibility criteria. Due to current practices of multi-site listing in the Mayo Clinic Transplant Enterprise, 
caregivers for patients on the heart and lung transplant lists at Mayo Florida or Mayo Arizona may also be 
considered for inclusion. Additionally, caregivers for heart or lung transplant patients at the Mayo Clinic who 
subsequently transfer their listing to a different (non-Mayo) transplant center would continue to be eligible for 
the study unless they withdrew consent.  Likewise, caregivers for heart or lung transplant candidates who 
receive their organ transplant during the course of the health coaching intervention would remain eligible to 
complete the study unless they withdrew consent.  
 
Approaching Caregivers for Participation 
 
Nominated caregivers or caregivers identified through the electronic medical record may be contacted 
by phone, mail, or in person to determine interest in this study. Caregivers not interested will have a mechanism 
to send a refusal. Non-responders will be sent a second interest letter. If the study team does not receive any 
correspondence from the caregiver, recruitment calls will be attempted 3 times. If the study team is unable to 
reach the caregiver for a call after 3 attempts, the participant will be declared a non-responder.  Caregivers may 
be contacted while the patient is deferred or active on the transplant waitlist.  If a waitlisted patient is 
transplanted, then the caregiver’s eligibility for recruitment will end once the transplanted patient is discharged 

Minimal Risk Protocol Template [IRB 10429.010] 
 
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from the hospital.  In such cases, a caregiver’s enrollment, baseline questionnaires, and randomization need to 
be complete prior to a patient’s post-transplant discharge in order for the caregiver to proceed with the study. 
 
Caregivers who agree to participate in this study will be randomized to either receive a wellness 
coaching intervention in which they will be assigned a wellness coach trained in motivational interviewing who 
will call the patient weekly for 12 sessions for an approximately 30-minute intervention or usual care (routine 
caregiver transplant education). Randomization will be stratified to type of transplant the patient they are caring 
for is waiting to receive (e.g. heart or lung). Participants who miss a call will be allowed a make-up call with the 
goal of finishing 12 calls over a 16-week period. The wellness coaching calls will be recorded and externally 
monitored by an independent expert to assure treatment fidelity, and all recordings will remain private. After 
completion of the intervention, all participants will be asked to complete the questionnaires a second time in 
addition to a qualitative/satisfaction survey by phone mail or by Redcap. Demographic data will be collected at 
the time of the initial questionnaires and verified with the follow-up questionnaires. If a participant leaves large 
sections or multiple pages of the questionnaires unanswered, they will be sent an IRB-approved letter asking 
that they complete the unanswered questions or indicate that the questions were purposely left unanswered. 
Psychometric surveys will be stored in a locked cabinet. Data will be entered into a secure password-protected 
REDCap database. Questionnaire and qualitative data will be kept in a password-protected REDCap database 
on our secure network. Audio files from health coaching sessions will also be stored in a password-protected 
folder on our secure network. 
 
Study Measures: 
 
1. Demographic information: Participations will be asked to self-report their sex, race, ethnicity, marital 
status, education level, type of transplant the patient they are caring for is waiting to receive, waiting 
time duration, and the relationship to transplant recipient to whom they are a caregiver.    
2. Questionnaires: 
PROMIS Global Health – Mental 2a 
PROMIS Global Health – Physical 2a 
PROMIS Satisfaction with Social Roles and Activities – Short Form 4a 
PROMIS Social Isolation – Short Form 4a 
Chew (2004) Health Literacy Screening Questions 
RISC – 10 
PANAS 
Zarit Burden Interview 
Perceived Stress Scale 
Patient Health Questionnaire-2 (PHQ-2) 
Generalized Anxiety Disorder -2 (GAD-2) 
 
 
Subject Information 
 
Target accrual is the proposed total number of subjects to be included in this study at Mayo Clinic. A “Subject” 
may include medical records, images, or specimens generated at Mayo Clinic and/or received from external 
sources.    

Minimal Risk Protocol Template [IRB 10429.010] 
 
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Target accrual:  60 patients and 60 caregivers 
 
Subject population (children, adults, groups):  Caregivers of adult patients on the heart and lung transplant 
waiting lists   
 
Inclusion Criteria:  Aged 18 or older who are the primary caregivers of patients listed (active, deferred, or 
temporarily inactive) for lung, heart/lung, or heart transplantation at Mayo Clinic in Rochester and 
Jacksonville, FL 
 
Exclusion Criteria:  Individuals younger than 18 will be excluded. Those who are non-English speaking, non-
verbal, or extremely hard of hearing will also be excluded. 
 
 
 
 
Review of medical records, images, specimens  
 
 
Check all that apply (data includes medical records, images, specimens).  
 
  Only data that exists before the IRB submission date will be collected.   
 
Date Range for Specimens and/or Review of Medical Records:   
Examples: 01/01/1999 through 12/31/2015, or all records through mm/dd/yyyy.  
 
Note: The Date Range must include the period for collection of baseline data, as well as follow-up data, 
if applicable. 
 
X  The study involves data that exist at the time of IRB submission and data that will be generated after IRB 
submission. Include this activity in the Methods section.  
Examples 
• The study plans to ask subjects to complete a questionnaire.  
 
  The study will use data that have been collected under another IRB protocol. Include in the Methods section 
and enter the IRB number from which the research material will be obtained. When appropriate, note when 
subjects have provided consent for future use of their data and/or specimens as described in this protocol.  
 
Enter one IRB number per line, add more lines as needed 
 
 Data    
 Specimens  
 Data & Specimens  ______________________________________ 
 
 Data    
 Specimens  
 Data & Specimens  ______________________________________ 
 

Minimal Risk Protocol Template [IRB 10429.010] 
 
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 Data    
 Specimens  
 Data & Specimens  ______________________________________ 
 
 
Data Analysis 
 
 
Power analyses may not be appropriate if this is a feasibility or pilot study, but end-point analysis plans are 
always appropriate even if only exploratory. Provide all information requested below, or provide justification if 
not including all of the information.  
 
Power Statement:  Not required for a pilot study. 
 
 
Data Analysis Plan: Descriptive statistics and change in secondary endpoints. 
 
 
Endpoints 
Primary: Acceptability and feasibility of wellness coaching for caregivers of thoracic transplant candidates. This 
will be obtained by looking at completion rate of intervention and qualitative surveys after the intervention is 
completed. 
Secondary:  Preliminary efficacy data for power calculation for larger R01 application and multisite study. We 
will look at change in reported outcomes of stress, caregiver burden, resilience, quality of life, affect, and 
mastery.