Improving Delivery of Patient-Centered Cardiac Rehabilitation
Phase: NA
Conditions: Cardiac Rehabilitation
Sponsor: University of California, San Francisco

Cover Page 
Improving Delivery of Patient-Centered Cardiac Rehabilitation 
NCT02105246 
August 11, 2018 
 

Study Protocol 
 
Background 
Ischemic heart disease (IHD) is the leading cause of death in Veterans and has been identified as a priority 
condition for improving healthcare within the VA. Exercise-based cardiac rehabilitation (CR) is an evidence 
based, cost effective therapy that reduces morbidity and mortality following acute myocardial infarction (MI), 
coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). The American Heart 
Association (AHA) and American College of Cardiology (ACC) recommend referral to CR as one of its 9 
performance measures for secondary prevention (along with aspirin, beta blockers, statins and smoking 
cessation) in patients with IHD. Unfortunately, despite the compelling benefits and widespread endorsement of 
its use, CR is vastly underutilized in VHA. A recent Presidential Advisory from theAHA concluded, “The 
remarkably wide treatment gap between scientific evidence of the benefits of cardiac rehabilitation and clinical 
implementation is unacceptable.” Only 35 (27%) of VA facilities offer CR programs, and less than 10% of 
eligible veterans receive this guideline-recommended therapy. Geographic distance is by far the largest barrier 
to participation. Of the 9.2 million veterans currently enrolled in VHA, 6.7 million (73%) live more than 60 
minutes from a VA CR center [based on geography data from VA Planning Systems Support Group (PSSG)]. 
Thus, there is an urgent need to adapt CR programs to improve access to and utilization of CR among rural 
veterans. 
 
In a recent study conducted at the Iowa City VA (Wakefield et al, 2014), 48 patients completed a home-based 
program and 12 patients completed face-to-face CR. There was no difference in blood pressure, lipid levels, 
weight, glycosylated hemoglobin or rate of rehospitalization between the two groups. Home-based CR 
participants were highly satisfied with their care and had a better completion rate than patients who underwent 
face-to-face CR (89% vs. 73%). Costs for home and center-based CR programs were comparable. These 
findings suggest that a home-based CR program is a viable, safe, and cost- effective alternative to center 
based programs. In a 2010 Cochrane review, there was no significant difference in mortality among patients 
randomly assigned to home-based CR vs. center-based CR.  
 
Objectives 
 
Test the hypothesis that patients undergoing home based cardiac rehabilitation will not differ in 6 minute walk 
time, physical activity, quality of life, patient and caregiver satisfaction, and re-hospitalization as compared with 
patients undergoing center-based cardiac rehabilitation. 
 
Aim 1. Determine whether automatic referral to home- vs. center-based CR increases patient participation in 
CR after hospitalization for myocardial infarction or coronary revascularization. 
Aim 2. Among patients who choose to participate in CR, compare the effectiveness of home- vs. center-based 
CR on six-minute walk distance, quality of life, and healthcare expenditures. 
Aim 3: Determine whether the effects of home vs. center-based CR differ by age, gender, race, ethnicity, 
distance from medical center, employment, socioeconomic status, social support, caregiver status, comorbid 
conditions, or patient preference. 
 
Study Design 
 
Cardiac rehabilitation involves exercise training, education, and lifestyle counseling for patients with cardiac 
conditions. Home and center-based cardiac rehabilitation programs, if followed by patients, are equally 
effective in their benefits on risk factors, health-related quality of life, death, and clinical events following acute 
myocardial infarction or coronary revascularization. This study will compare the effectiveness of existing 
cardiac rehabilitation programs. The San Francisco VA Medical center offers a home-based (but not a center 
based) cardiac rehabilitation program to patients who are hospitalized for myocardial infarction, percutaneous 
coronary intervention, or coronary artery bypass grafting. The other study sites offer a center-based (but not a 
home-based) cardiac rehabilitation to the same group of patients. All facilities have initiated a comprehensive 
CR intervention with 7 components: 
 
1. Educate and engage stakeholders (grand rounds, posters, brochures, one-on-one meetings) 
2. Automate referrals 

3. Standardize templates and stop codes for consults, progress notes, exercise prescription, and the patients' 
Individualized Treatment Plans 
4. Use database to track all patients referred; monitor % enrolled, number of sessions completed. 
5. Standardize outcome assessment 
6. For CABG patients, provide in-hospital assessment and phase I cardiac rehabilitation; coordinate care with 
home PT 
7. Offer a phase II cardiac rehabilitation program within 6 months of hospitalization. 
 
The only difference between the sites is that San Francisco offers a home-based cardiac rehab program and 
other sites will offer a center-based cardiac rehab program. Research outcomes will include processes of care 
(% of eligible patients referred, % enrolled, average number of sessions completed, provider knowledge) and 
patient outcomes (6 minute walk distance, physical activity, quality of life, patient and caregiver satisfaction, 
rehospitalization, mortality). The study will evaluate the effectiveness of each CR program on these outcomes. 
In addition, research participants will be asked to participate in a total of 3 additional study visits. The visits will 
take place 3 months, 6 months, and 12 months after their enrollment in the cardiac rehabilitation program. 
Medical records will be reviewed and death certificates will be obtained for up to 10 years of follow-up. 
 
Statistical Analysis Plan 
 
The outcomes listed will be measured at baseline, and then at 3, 6, and 12 months following first visit to CR. 
Prior to inferential statistics, we will use descriptive statistics and graphs to explore distributions, univariate 
outliers, and basic bivariate associations with home- vs. center-based CR. We will then compare baseline 
characteristics of the two groups to examine differences on key subgroup variables including age and type of 
procedure resulting in the need for CR. Imbalanced baseline measures will be included as covariates in 
outcome analyses. To appropriately model these nested data, we will use linear mixed models also called 
multilevel or hierarchical linear models. Our primary outcomes on which only the patient or their caregiver 
provide data will be analyzed using a multivariate regression model with a simple random -effects structure 
with repeated-measures. We anticipate that patients who agree to enroll in home-based CR will be different 
than those who agree to enroll in center- based CR. Therefore, we will use other variables measured at 
baseline to construct a propensity score for home- vs. center-based CR, and we will adjust the multivariable 
analyses for this propensity score. Planned subgroup analyses will include the effects of the following 
predictors on outcomes: age, gender, race/ethnicity, SES, distance to nearest facility that can provide 
rehabilitation, and presence of caregivers. We will determine whether these same socio-demographic factors 
are associated with patient preference. We will also conduct subgroup analyses where we have identical 
measures from patients and caregivers.  

Study Application (Version 1.14)
1.0
General Information
*Enter the full title of your study:
Improving Delivery of Patient-Centered Cardiac Rehabilitation
 
 
*Enter the study number or study alias
Improving Delivery of Patient-Centered Cardiac Rehabilitation 
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
2.0
Add Department(s)
2.1 List departments and/or research programs associated with this study:
Primary 
Dept?
Department Name
UCSF - 
 - M_MED-VAMC-ADMIN
138331
 
3.0
Assign key study personnel(KSP) access to the study
3.1 *Please add a Principal Investigator for the study:
 
Mary A Whooley
Select if applicable
Department Chair
Resident
Fellow
If the Principal Investigator is a Fellow, the name of the Faculty Advisor must be supplied below.
 
3.2 If applicable, please select the Research Staff personnel:
 
A) Additional Investigators
Redberg, Rita F 
 Other Investigator
Schopfer, David, MD 
 Other Investigator
B) Research Support Staff
Ahi, Tara 
 Study Coordinator
Bettencourt, Michael 
 Study Recruiter

Hay, Kristen 
 Research Assistant
Lee, Rado 
 Study Coordinator
Munson, Scott 
 Research Assistant
Piros, Kimberly 
 Study Nurse
Williams, Katherine PhD 
 Study Coordinator
3.3 *Please add a Study Contact:
 
Ahi, Tara 
Munson, Scott 
Whooley, Mary A 
Williams, Katherine PhD 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
3.4 If applicable, please add a Faculty Advisor/Mentor:
 
3.5 If applicable, please select the Designated Department Approval(s):
 
Add the name of the individual authorized to approve and sign off on this protocol from your 
Department (e.g. the Department Chair or Dean).
4.0
 Qualifications of Key Study Personnel
4.1  November, 2015 - NEW Definition of Key Study Personnel and CITI Training 
Requirements:    
  
include the Principal Investigator, other investigators and research 
UCSF Key Study Personnel 
personnel who are directly involved in conducting research with study participants or who are directly 
involved in using study participants’ identifiable private information during the course of the 
research. Key Personnel also include faculty mentors/advisors who provide direct oversight to 
        
Postdoctoral Fellows, Residents and Clinical Fellows serving as PI on the IRB application.
 
The 
IRB requires that all Key Study Personnel complete Human Subjects Protection 
Training through CITI prior to approval of a new study, or a modification in 
which KSP are being added. More information on the CITI training requirement 
can be found on our website.
    
   
List the study responsibilities and qualifications of any individuals who qualify as Key Study 
 (KSP) at UCSF and affiliated sites ONLY by clicking the "Add a new row" button. 
Personnel
This 
 
information is required and your application will be considered incomplete without it.
KSP Name
Description of Study 
Responsibilities
Qualifications
Whooley, Mary A
Principal Investigator
Dr. Whooley is a professor in 
the Department of Medicine at 
UCSF and an attending 
physician at the San Francisco 
VA Medical Center.

Schopfer, David, MD
Co-investigator
Dr. Schopfer is a cardiologist 
with experience working on a 
number of cardiology studies 
at the San Francisco VA 
Medical Center.
Piros, Kimberly
Study Nurse
Kimberly Piros is a registered 
nurse who has extensive 
experience working with 
patients at the San Francisco 
VA Medical Center. He is the 
primary nurse provider 
associated with the VA's 
Healthy Heart Program.
Pabst, Mark S
Project Coordinator/Manager
Mark Pabst has ten years 
experience managing clinical 
research studies at UCSF and 
the San Francisco VA Medical 
Center.
Munson, Scott
Research Assistant
Scott Munson has worked on 
Dr. Whooley's research 
projects for over five years 
and has superior knowledge of 
UCSF and VA research 
regulations.
Redberg, Rita F
Co-investigator
Dr. Redberg is a cardiologist 
with expertise in the effects of 
exercise on cardiovascular 
disease.
Ahi, Tara
Clinical research coordinator
Tara Ahi is a UCSF Clinical 
Research Coordinator Asst at 
the SFVAMC.
Bettencourt, Michael
Study Recruiter
Michael Bettencourt is an 
exercise physiologist who 
works closely with the 
subjects in this study and will 
be responsible for recruiting 
subjects into the study.
Hay, Kristen
Research Assistant
Kristen Hay has extensive 
experience working with 
patients at the SFVAMC. She 
is currently working with the 
Million Veterans Program while 
assisting with the Healthy 
Heart Program as well.
Lee, Rado
Study coordinator
Rado Lee has extensive 
experience in tracking 
expenses and coordinating 
study efforts
5.0
 Initial Screening Questions - Updated 9/13
(Note: You must answer every question on this page to proceed).
If you are converting to the new form, check questions 5.4, 5.6, 5.7, 5.8 
and 5.10 before saving and continuing to the next section.

5.1  
 Application type:
*
Full Committee 
Expedited 
Exempt 
5.2  
 Risk level 
:
*
(Help Text updated 9/13)
Minimal risk 
Greater than minimal risk 
5.3  
 Subject contact:
*
Yes (including phone, email or web contact) 
No (limited to medical records review, biological specimen analysis, and/or data analysis) 
5.4  
 Funding (past or present):
*
Funded or will be funded (external sponsor, gift, program or specific internal or departmental funds) 
Unfunded (no specific funds earmarked for this project) 
Unfunded student project 
5.5  
The Principal Investigator and/or one or more of the key study personnel has 
 
* 
financial interests
related to this study:
  Yes   
  No
If 
, the Conflict of Interest Advisory Committee (COIAC) office may contact you for additional 
Yes
information.
5.6  
This is an investigator-initiated study:
* 
 Yes   
 No
5.7  
This study 
 involves retrospective records review and/or identifiable biospecimen analysis:
* 
ONLY
  Yes   
  No
5.8  
This is a clinical trial:
* 
 Yes   
 No
Clinical Trial Registration
"NCT" number for this trial:
NCT02105246
5.9  * This is a multicenter study:
 Yes   
 No
5.10  
This application involves the study of 
 or 
 drugs, devices, biologics or in vitro 
* 
unapproved
approved

diagnostics:
  Yes   
  No
5.11  * This application involves a Humanitarian Use Device:
No 
Yes, and it includes a research component 
Yes, and it involves clinical care ONLY 
5.12  
This study involves human stem cells (including iPS cells and adult stem cells), gametes or 
* 
embryos:
No 
Yes, and requires CHR and GESCR review 
Yes, and requires GESCR review, but NOT CHR review 
5.13  * This is a CIRB study (e.g. the NCI CIRB will be the IRB of record):
  Yes   
  No
5.14  
This application includes a request to rely on another IRB (other than NCI CIRB):
* 
  Yes   
  No
Note: If this request is approved, the CHR will 
 review and approve this study. Another institution will 
NOT
be the IRB of record.
6.0
 Funding
6.1  Identify all sponsors and provide the funding details. If funding comes from a Subcontract, please list 
only the Prime Sponsor:        
 
Note: we require only a P Number 
 an A Number for 
OR
funding coming through UCSF. Please avoid these common errors in funding 
       
documentation: 
 
 
DO NOT add the A Number if a P Number was already provided OR update 
the A Number field when a new funding cycle begins. The IRB does NOT 
use this information or want these changes made.   
 add a grant continuation as a new funding source. 
DO NOT
External Sponsor:
View 
Details
Sponsor Name
Sponsor Type
Awardee 
Institution
Contract 
Type:
UCSF RAS 
"P 
number" 
or 
eProposal 
number 
UCSF 
RAS 
System 
Award 
Number 
("A" + 
6 
digits) 
Patient-Centered 
Outcomes Research 
Inst 
05 
UCSF 
 
P0058380  

Sponsor Name:
Patient-Centered Outcomes Research Inst 
Sponsor Type:
05 
Sponsor Role:
Funding
Grant/Contract Number:
 
Awardee Institution:
UCSF 
Is Institution the Primary Grant 
Holder:
Yes 
Contract Type:
 
UCSF RAS "P number" or 
eProposal number:
P0058380 
UCSF RAS System Award Number 
("A" + 6 digits):
 
Grant Number for Studies Not 
Funded thru UCSF:
 
Grant Title:
 
PI Name:
(If PI is not the same as identified 
on the study.)
 
Significant Discrepancy:
 
Gift, Program, or Internal Funding (check all that apply):
Funded by gift (specify source below)
Funded by UCSF or UC-wide program (specify source below)
Specific departmental funding (specify source below, if applicable)
List the gift, program, or departmental funding source:
6.2    
   
If you tried to add a sponsor in the question above and it was not in the list, follow these steps:
If funding has already been awarded or the contract is being processed by the Office of 
Sponsored Research (OSR) or Industry Contracts Division (ICD), your sponsor is already in the 
system and the project has an eProposal Proposal or Award number. Check with your 
department's OSR Staff or ICD Officer to ask how the sponsor is listed in the UC sponsor list 
and what the Proposal or Award number is. Click 
 to find your OSR staff and 
 to find 
here
here
your ICD staff.
If your sponsor is not yet in the list, enter it in the box below.
Sponsor not in list 
Only if your sponsor is not yet in the list, type the sponsor's name:
If the funding is administered by the UCSF Office of Sponsored Research, your study will not 
receive CHR approval until the sponsor and funding details have been added to your 
application.
6.3  
This study is currently supported in whole or in part by Federal funding OR has received ANY 
* 
Federal funding in the past 
:
(Help Text updated 9/13)
  Yes   
  No
If 
, indicate which portion of your grant you will be attaching:
yes

The Research Plan, including the Human Subjects Section of your NIH grant or subcontract
For other federal proposals (contracts or grants), the section of the proposal describing human 
subjects work
The section of your progress report if it provides the most current information about your human 
subjects work
The grant is not attached. The study is funded by an award that does not describe specific plans for 
human subjects, such as career development awards (K awards), cooperative agreements, program 
projects, and training grants (T32 awards) OR UCSF (or the affiliate institution) is not the prime 
recipient of the award
7.0
 Sites
7.1  Institutions (check all that apply):
UCSF
China Basin
Helen Diller Family Comprehensive Cancer Center
Mission Bay
Mount Zion
San Francisco General Hospital (SFGH)
SF VA Medical Center (SF VAMC)
Blood Centers of the Pacific (BCP)
Blood Systems Research Institute (BSRI)
Fresno (Community Medical Center)
Gallo
Gladstone
Institute on Aging (IOA)
Jewish Home
SF Dept of Public Health (DPH)
7.2  Check all the other types of sites not affiliated with UCSF with which you are cooperating or 
collaborating on this project 
:
(Help Text updated 9/13)
Other UC Campus
Other institution
Other community-based site
Foreign Country
List the foreign country/ies:
7.3  Check any research programs this study is associated with:
Cancer Center
Center for AIDS Prevention Sciences (CAPS)
Global Health Sciences
Immune Tolerance Network (ITN)
Neurosciences Clinical Research Unit (NCRU)
Osher Center
Positive Health Program
8.0
 Studies Involving Other Sites

8.1  UCSF is the coordinating center:
 Yes   
 No
If 
, describe the plan for communicating safety updates, interim results, and other information that 
Yes
may impact risks to the subject or others among sites:
Important information, including safety updates and interim results, will be communicated to other sites by 
means of study memorandae (SM). Study memorandae will be numbered sequentially in the order in 
which they are issued and a complete list will be stored at the coordinating center. Each of these 
documents will be prepared by coordinating center personnel, signed by the coordinating center's principal 
investigator, and then sent by email to the principal investigator and main study contact at each study 
satellite site.
 
If 
, describe the plan for sharing modification(s) to the protocol or consent document(s) among sites:
Yes
All modifications to protocol and consent documentation will be communicated through the distribution of 
study memorandae to principal investigators and main study contacts at each study site. These documents 
will detail the exact changes made to protocol and consent documents, including specific change to 
language in the protocol and/or consent.
 
8.2  Check any other UC campuses with which you are collaborating on this research study:
UC Berkeley
UC Davis
Lawrence Berkeley National Laboratory (LBNL)
UC Irvine
UC Los Angeles
UC Merced
UC Riverside
UC San Diego
UC Santa Barbara
UC Santa Cruz
8.3  Are the above UC campuses requesting to rely on UCSF's IRB (check all that apply):
Yes (Submit a reliance request through the UC IRB Reliance Registry)
No (Complete IRB Approval Certification section)
9.0
 Outside Site Information
9.1  
 
Outside Site Information
Click "Add a new row" to enter information for a site. Click it again to add a second site again to add a 
third site, a fourth site, etc.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
VA Ann Arbor Healthcare System

Contact name:
Claire Duvernoy
Email:
duvernoy@med.umich.edu
Phone:
(734) 936-7507
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of record for this study 
The non-affiliated site is not engaged in the human subjects research and has 
provided a letter of support 
If the other site's IRB approval letter is available now, attach it to the 
application.  If the IRB approval letter is not yet available, submit it once you 
receive it. 
  
  Or, if the other site is 
 in human subjects research, attach the 
 
not engaged
letter of support to your application.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Pittsburg VA Healthcare System
Contact name:
Dan Forman
Email:
DEFORMAN@PARTNERS.ORG
Phone:
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The

1.  
1.  
1.  
1.  
1.  
1.  
1.  
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of record for this study 
The non-affiliated site is not engaged in the human subjects research and has 
provided a letter of support 
If the other site's IRB approval letter is available now, attach it to the 
application.  If the IRB approval letter is not yet available, submit it once you 
receive it. 
  
  Or, if the other site is 
 in human subjects research, attach the 
 
not engaged
letter of support to your application.
10.0
 Study Design
10.1  
Study design 
:
* 
(Help Text updated 9/13)
Cardiac rehabilitation involves exercise training, education, and lifestyle counseling for patients with 
cardiac conditions. Home and center-based cardiac rehabilitation programs, if followed by patients, are 
equally effective in their benefits on risk factors, health-related quality of life, death, and clinical events 
following acute myocardial infarction or coronary revascularization. This study will compare the 
effectiveness of existing cardiac rehabilitation programs. The San Francisco VA Medical center offers a 
home-based (but not a center-based) cardiac rehabilitation program to patients who are hospitalized for 
myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting. The other 
study sites offer a center-based (but not a home-based) cardiac rehabilitation to the same group of 
patients. All facilities have initiated a comprehensive CR intervention with 7 components:
 
Educate and engage stakeholders (grand rounds, posters, brochures, one-on-one meetings)
 
Automate referrals
 
Standardize templates and stop codes for consults, progress notes, exercise prescription, and the 
patients' Individualized Treatment Plans
 
Use database to track all patients referred; monitor % enrolled, number of sessions completed.
 
Standardize outcome assessment
 
For CABG patients, provide in-hospital assessment and phase I cardiac rehabilitation; coordinate 
care with home PT
 
Offer a phase II cardiac rehabilitation program within 6 months of hospitalization.
 
The only difference between the sites is that San Francisco offers a home-based cardiac rehab program 
and other sites will offer a center-based cardiac rehab program.
 
Research outcomes will include processes of care (% of eligible patients referred, % enrolled, average 
number of sessions completed, provider knowledge) and patient outcomes (6 minute walk distance, 
physical activity, quality of life, patient and caregiver satisfaction, re-hospitalization, mortality). The 
study will evaluate the effectiveness of each CR program on these outcomes. All 6 minute walk tests 
associated with the home-based portion of the study will be conducted at the San Francisco VA Medical 
Center.
 

 
In addition, research participants will be asked to participate in a total of 2 additional study visits. The 
visits will take place 3 months and 6 months after their enrollment in the cardiac rehabilitation program. 
Medical records will be reviewed and death certificates will be obtained for up to 10 years of follow-up.  T
his protocol will require national access to VA electronic health records through CAPRI and/or VistAWeb.
10.2  If this is a clinical trial, check the applicable phase(s) 
:
(Help Text updated 9/13)
Phase I
Phase II
Phase III
Phase IV
11.0
 Scientific Considerations
11.1  Hypothesis 
:
(Help Text updated 9/13)
This study has a hypothesis:
 Yes   
 No
If yes, state the hypothesis or hypotheses:
Patients undergoing home based cardiac rehabilitation will not differ in 6 minute walk time, physical 
activity, quality of life, patient and caregiver satisfaction, and re-hospitalization as compared with 
patients undergoing center-based cardiac rehabilitation.
11.2  
List the specific aims:
* 
Aim 1. Determine whether automatic referral to home- vs. center-based CR increases patient participation 
in CR after hospitalization for myocardial infarction or coronary revascularization.
 
Aim 2. Among patients who choose to participate in CR, compare the effectiveness of home- vs. center-
based CR on six-minute walk distance, quality of life, and healthcare expenditures.
 
Aim 3: Determine whether the effects of home vs. center-based CR differ by age, gender, race, ethnicity, 
distance from medical center, employment, socioeconomic status, social support, caregiver status, 
comorbid conditions, or patient preference.
 
11.3  Statistical analysis: 
The outcomes listed will be measured at baseline, and then at 3 and 6 months following first visit to CR. 
Prior to inferential statistics, we will use descriptive statistics and graphs to explore distributions, 
univariate outliers, and basic bivariate associations with home- vs. center-based CR. We will then 
compare baseline characteristics of the two groups to examine differences on key subgroup variables 
including age and type of procedure resulting in the need for CR. Imbalanced baseline measures will be 
included as covariates in outcome analyses.
 
To appropriately model these nested data, we will use linear mixed models also called multilevel or 
hierarchical linear models. Our primary outcomes on which only the patient or their caregiver provide 
data will be analyzed using a multivariate regression model with a simple random -effects structure with 
repeated-measures. We anticipate that patients who agree to enroll in home-based CR will be different 
than those who agree to enroll in center- based CR. Therefore, we will use other variables measured at 
baseline to construct a propensity score for home- vs. center-based CR, and we will adjust the 
multivariable analyses for this propensity score. Planned subgroup analyses will include the effects of the 
following predictors on outcomes: age, gender, race/ethnicity, SES, distance to nearest facility that can 
provide rehabilitation, and presence of caregivers. We will determine whether these same socio-
demographic factors are associated with patient preference. We will also conduct subgroup analyses 
where we have identical measures from patients and caregivers.

 
11.4  If this study has undergone scientific or scholarly review, please indicate which entity performed the 
review:
Cancer Center Protocol Review Committee (PRC) (Full approval is required prior to final CHR approval 
for cancer-related protocols.)
CTSI Clinical Research Center (CRC) advisory committee
Departmental scientific review
Other:
Specify 
:
Other
12.0
 Background
12.1  Background:
Ischemic heart disease (IHD) is the leading cause of death in Veterans and has been identified as a priority 
condition for improving healthcare within the VA. Exercise-based cardiac rehabilitation (CR) is an evidence-
based, cost effective therapy that reduces morbidity and mortality following acute myocardial infarction 
(MI), coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). The American 
Heart Association (AHA) and American College of Cardiology (ACC) recommend referral to CR as one of its 
9 performance measures for secondary prevention (along with aspirin, beta blockers, statins and smoking 
cessation) in patients with IHD. Unfortunately, despite the compelling benefits and widespread 
endorsement of its use, CR is vastly underutilized in VHA. A recent Presidential Advisory from theAHA 
concluded, “The remarkably wide treatment gap between scientific evidence of the benefits of cardiac 
rehabilitation and clinical implementation is unacceptable.” Only 35 (27%) of VA facilities offer CR 
programs, and less than 10% of eligible veterans receive this guideline-recommended therapy. Geographic 
distance is by far the largest barrier to participation. Of the 9.2 million veterans currently enrolled in VHA, 
6.7 million (73%) live more than 60 minutes from a VA CR center [based on geography data from VA 
Planning Systems Support Group (PSSG)]. Thus, there is an urgent need to adapt CR programs to improve 
access to and utilization of CR among rural veterans.
 
12.2  Preliminary studies:
In a recent study conducted at the Iowa City VA (Wakefield et al, 2014), 48 patients completed a home-
based program and 12 patients completed face-to-face CR. There was no difference in blood pressure, 
lipid levels, weight, glycosylated hemoglobin or rate of rehospitalization between the two groups. Home-
based CR participants were highly satisfied with their care and had a better completion rate than 
patients who underwent face-to-face CR (89% vs. 73%). Costs for home and center-based CR 
programs were comparable. These findings suggest that a home-based CR program is a viable, safe, 
and cost- effective alternative to center-based programs. In a 2010 Cochrane review, there was no 
significant difference in mortality among patients randomly assigned to home-based CR vs. center-
based CR.
12.3  References:
 
If you have a separate bibliography, attach it to the submission with your other study documents. 
13.0
 Sample Size and Eligibility
13.1  Number of subjects that will be enrolled at UCSF and affiliated institutions:

200
13.2  Total number of subjects that will be enrolled at all sites 
:
(Help Text updated 9/13)
400
13.3  Estimated number of people that you will need to consent and screen here (but not necessarily 
enroll) to get the needed subjects:
400
13.4  Explain how and why the number of subjects was chosen 
:
(Help Text updated 9/13)
Sample size estimation for the difference between two groups over four assessments assuming a linear 
trend. The estimate is based on a two-sided alpha of .05, power of .90, a constant correlation of 0.5 
among all repeated measurements, and a 5% overall attrition. San Francisco will enroll 200 participants 
while the other centers will enroll 100 participants each with a study total of 400 participants. With these 
assumptions, a composite effect of .5 can be detected
 
13.5  * Eligible age range(s):
0-6 years
7-12 years
13-17 years
18+ years
13.6  Inclusion criteria:
CABG within 6 months prior to first session
PCI within 6 months prior to first session
Acute MI within 6 months prior to first session
13.7  Exclusion criteria:
Age < 18 years
Pregnant
Behavioral or cognitive limitations that interfere with performing exercise training
Significant movement disorder that interferes with exercise training
Blind, deaf or mute
Homeless (or unstable housing anticipated during the next 3 months)
LVEF <35% without ICD
Staged PCI with significant remaining lesion
Decompensated heart failure
QTc > 500 msec and no ICD
6MWT < 75 m (post-op) or < 150 m (non-surgical)
Long-term (>30 days) SNF placement
Atrial arrhythmia not rate controlled
Mobitz Type II or 3
 degree AV block without pacemaker
rd
Deceased
History of unprovoked or exercise-induced VT, VF or syncope with no ICD
Concerning ventricular ectopy in past 24 hours with no ICD (Lown grading system)
Polymorphic/multiform PVCs
Couplets, Salvos, or non-sustained VT
R on T pattern
>10 PVCs per minute

13.8  There are inclusion or exclusion criteria based on gender, race or ethnicity:
  Yes   
  No
If
, please explain the nature and rationale for the restrictions:
 yes
14.0
 Other Approvals and Registrations
14.1  
 
Do any study activities take place on patient care units:
* 
  Yes   
  No
If 
, attach a letter of support for the study from the involved patient care manager(s).
Yes
14.2  
Does your protocol involve any radiation exposure to patients/subjects? The UCSF Radiation 
* 
 
Safety Committee requires review of your protocol if it includes administration of radiation as part of 
standard of care 
 research exposures:
OR
  Yes   
  No
14.3  
This study may generate genetic data that may be broadly shared (e.g. submitted to NIH for 
* 
 in 
, 
, etc):
Genome-Wide Association Studies (GWAS)
dbGaP TCGA
  Yes   
  No
14.4  
This study involves administration of vaccines produced using recombinant DNA technologies to 
* 
human subjects:
  Yes   
  No
14.5  
This study involves human gene transfer (NOTE: Requires NIH Recombinant DNA Advisory 
* 
Committee (RAC) review prior to CHR approval):
  Yes   
  No
14.6  This study involves other regulated materials and requires approval and/or authorization from the 
following regulatory committees:
Institutional Biological Safety Committee (IBC)
Specify BUA #:
Institutional Animal Care and Use Committee (IACUC)
Specify IACUC #:
Radiation Safety Committee
Specify RUA #:
Radioactive Drug Research Committee (RDRC)

Specify RDRC #:
Controlled Substances
15.0
 Procedures
15.1  
Procedures/Methods 
* 
(Help Text updated 9/13)   For clinical research list all study procedures, test 
and treatments required for this study, including when and how often they will be performed. If 
there are no clinical procedures, describe the Methods:
The following table lists measurements that will be collected as part of usual care (whether or not the 
patient participates in the study). This includes information collected from both medical records and 
subject interview, and the timepoint at which the information is collected. This protocol will require 
Information will not be 
national access to VA electronic health records through CAPRI and/or VistAWeb
used or stored from subjects who withdraw or are withdrawn from the study. 
 
 
Clinical (Standard of Care)
Measurements
Baseline 12 weeks 6 months  
 
Date
X
X
X
 
Resting blood pressure (mm Hg)
X
X
X
 
Resting pulse (beats/min)
X
X
X
 
Weight (kg, lbs)
X
X
X
 
Resting O2 sat
X
X
X
 
Height (cm, in)
X
 
 
 
Waist circumference (cm)
X
 
 
 
Hip circumference (cm)
X
 
 
 
Steps per week
X
X
X
 
6MWT 
 
standardized course
Date
X
 
 
 
Start time ( _ _ : _ _ )
X
 
 
 
End time ( _  _ : _ _ )
X
 
 
 
Total distance (meters? feet?)
X
 
 
 
Peak heart rate
X
 
 
 
O2 sat at end of course
X
 
 
 
Max perceived exertion (Borg 1- 10)
X
 
 
 
Comments
X
 
 
 
 
 
 
Baseline12 Weeks6months 
Medication use
Aspirin
X
X
X  
Clopidogrel
X
X
X  
Beta blocker
X
X
X  
Angiotensin receptor blocker (ACE/ARB)
X
X
X  
Calcium channel blocker
X
X
X  
Statin
X
X
X  
Niacin
X
X
X  
Fish oil
X
X
X  
Other cholesterol medication
X
X
X  
Diuretic
X
X
X  
Nitrate
X
X
X  
Insulin
X
X
X  
Oral hypoglycemic
(e.g., metformin, glipizide)
X
X
X  
Warfarin
X
X
X  
Factor Xa inhibitor
(e.g., Rivaroxaban, Apixaban)
X
X
X  
Proton pump inhibitor
(e.g., omeprazole, pantoprazole)
 
 
 
 
Other?
X
X
X  
Labs
Lipid panel (HDL, total chol, triglyceride, calculated LDL)
X
X
X  

Direct LDL
X
 
X  
Complete blood count (CBC)
X
 
X  
Liver function tests
X
 
X  
Albumin
X
 
X  
Urine microalbumin
X
 
X  
Urine creatinine
X
 
X  
Electrolytes (Na, K, Cl, C02)
X
 
X  
Glucose
X
 
X  
BUN
X
X
X  
Hemoglobin A1C
X
X
X  
Creatinine
X
X
X  
eGFR (calculated)
X
X
X  
B-type natriuretic peptide (BNP)
X
X
X
 
Troponin-I
X
 
 
High sensitivity CRP*
X
 
 
Questionnaires
CCS angina classification?
Self-reported angina frequency?
X
X
X
 
 
 
 
Activity during the past month?
Not at all active
A little active (1 to 2 times/month)
Fairly active (3 to 4 times/month) Quite active (1 to 2 times/week)
Very active (3 to 4 times/week)
Extremely active (5 or more times/week)
 
 
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
Typical week during the past month
F requency 
ntensity 
ime
I 
T 
T ype
 
 
 
 
 
X
 
 
 
 
 
X
 
 
 
 
 
X
 
 
 
 
 
 
Number of hours sitting per weekday
 
 
 
 
Overall quality of life
X
X
X
 
Disease-specific quality of life
X
X
X
 
Depressive symptoms
X
X
X
 
Anxiety symptoms
X
X
X
 
Positive affect
X
X
X
 
Servings fruits/vegetables per day
X
X
X
 
Smoking
X
X
X
 
Alcohol use
X
X
X
 
Drug use
X
X
X
 
Comorbid medical conditions
X
X
X
 
 
 
The following table lists all information collected from study subjects for research only. This includes 
information collected from subject interviews, questionnaires, and other research activities (i.e. the six 
minute walk test conducted at months 3 and 6). The table also includes the timepoint at which the 
information is collected.
 
Research
Measurements
Baseline12 weeks6 months 
 
6MWT 
 
standardized course
 
Date
SOC
X
X
 
 
Start time ( _ _ : _ _ )
SOC
X
X
 
 
End time ( _  _ : _ _ )
SOC
X
X
 
 
Total distance (meters? feet?)
SOC
X
X
 
 
Peak heart rate
SOC
X
X
 
 
O2 sat at end of course
SOC
X
X
 
 
Max perceived exertion (Borg 1-10)
SOC
X
X
 
 
Comments
SOC
X
X
 
 
Trails A and B (seconds to complete) X
X
X
 
Digit symbol (# correct in 120 sec)
X
 
X
 
Number of chair stands in 30 sec
X
 
X
 
Overall quality of life
X
X
X
 
Disease-specific quality of life
X
X
X
 

Satisfaction with health care
X
X
X
 
Sleep quality
X
X
X
 
Positive affect
X
X
X
 
Caregiver communication
X
X
X
 
Functional status (ADLs, IADLs)
X
X
X
 
Cardiac self-efficacy
X
X
X
 
Exercise self-efficacy
X
X
X
 
Patient Activiation
X
X
X
 
Rate My Plate
X
X
X
 
Servings fruits/vegetables per day
X
X
X
 
Grams of saturated fat per day
X
X
X
 
Medication adherance
X
X
X
 
Smoking
X
X
X
 
Other Outcomes
 
 
 
 
Days until resume driving
 
X
 
 
Days until resume intercourse
 
X
 
 
Days until resume work
 
X
 
 
Patient (out of pocket) expenses
 
X
 
 
Knowledge about cardiac disease
X
X
X
 
Days until rehospitalization
X
X
X
 
Reason for rehospitalization
X
X
X
 
Days until death
X
X
X
 
Cause of death
X
X
X
 
 
Tandem Stand Test                                         X                X              X
Side by side Stand Test                               X                  X              X
Heel Toe Stand Test                                      X                  X            X
    
 
 
 
 
 
 
 
If you have a procedure table, attach it to the submission with your other study documents.
15.2  Interviews, questionnaires, and/or surveys will be administered or focus groups will be conducted:
 Yes   
 No
List any standard instruments used for this study:  
Trails A and B coginitive function tests
Digit symbol cognitive function test
Seattle Angina Questionnaire
Patient Activation Measure
International Physical Activity Questionnaire
Index of Activities of Daily Living
Dietary Assessment Medication Adherence
Perceived Stress
Patient Satisfaction in Healthcare
AUDIT
REAP
MOCA
PHQ 8
DASI
 
 
Attach any non-standard instruments at the end of the application.

15.3  Conduct of study procedures or tests off-site by non-UCSF personnel:
  Yes   
  No
If yes, explain:
 
15.4  Sharing of experimental research test results with subjects or their care providers:
  Yes   
  No
If yes, explain:
15.5  
Specimen collection for future research and/or specimen repository/bank administration:
* 
  Yes   
  No
15.6  Time commitment (per visit and in total):
Baseline visit will include an additional 1 hour of research related activity
Month 3 and Month 6 follow up visits will take approximately 1 hour and 30 minutes for research activities. 
Total time committment will be approximately 4 hours over 6 months.
 
15.7  Locations:
All study activities and data collection will take place either by telephone or at the San Francisco VA 
Medical center. All telephone calls to collect data will originate from the SFVAMC.
 
15.8  Describe the resources in place to conduct this study in a way that assures protection of the rights 
and welfare of participants:
We have the neccessary staff, space, and resources to complete the study. All staff have completed human 
subject's training as required by UCSF and the SFVAMC. The SFVAMC has on-site 24 hour emergency 
medical and psychiatric care should the need for these resources arise.
 
16.0
 Alternatives
16.1  Study drug or treatment is available off-study:
Yes 
No  
Not applicable 
16.2  
Is there a standard of care (SOC) or usual care that would be offered to prospective subjects at 
* 
UCSF (or the study site) if they did not participate:
 Yes   
 No
If yes, describe the SOC or usual care that patients would receive if they choose not to participate:

If subjects choose not to participate in this study they can continue to particpate in the standard of care 
cardiac rehabilitation option(s) available to them. At the San Francisco VA Medical Center these options 
include participating in a home-based CR program administered through the SFVAMC or referral to an 
outside center-based CR program.
 
16.3  Describe other alternatives to study participation that are available to prospective subjects:
Patients may elect to participate in cardiac rehabilitation without being part of the study or they may elect 
to not participate in any cardiac rehabilitation program.
17.0
 Risks and Benefits
17.1  
Risks and discomforts:
* 
Questionnaires: The questionnaires will involve personal questions. Some of the questions may make the 
participant uncomfortable or upset.
 
6 minute walk test: The risks of any exercise test include disorders of the heart beat, abnormal blood 
pressure responses and dizziness. However, these risks are exceedingly rare during the 6 minute walk test.
 
Balance tests:
Risks associated with the balance tests include abnormal blood pressure responses and dizziness and 
potential fall. These risks are excedingley rare
 
 
Confidentiality: Participation in research will involve a loss of privacy, but information will be handled as 
confidentially as possible. Names will not be used in any published reports about this study.
 
 
17.2  Steps taken to minimize risks to subjects:
Questionnaires: Participants are free to decline the questionnaires. Any subject identified to be actively 
suicidal at the study appointment or during a follow-up interview will receive immediate psychiatric 
referral, which is available 24 hours per day at the San Francisco VA medical Center.
 
6 minute walk test: Participants will be monitored closely while assessments are made in the hospital. 
Testing will be halted for chest pain or shortness of breath.
 
Balance tests: Study personnel will stand next to subjects when they perform the balance tests. This will 
allow personnel to catch study subjest should they fall. In addition, balance tests will be conducted next 
toa wall with attached bar that study subjects will be able to grab if they become dizzy.
 
Confidentiality: Names will not be used in any published reports about this study. Use of identifying 
information will be minimized and adhere to VA privacy guidelines for storage. (double locked file cabinets 
and encrypted electronic sources)
 
17.3  Benefits to subjects:
 
  Yes   
  No
If yes, describe:
 
17.4  Benefits to society:
If home based cardiac rehabilitation is proven equitable to center based cardiac rehabilitation, the costs 
associated with care could be lower and the overall incidence of repeated revascularization could be 

lower. The travel burden related to center based cardiac rehabilitation could be eliminated. Patient 
satisfaction and quality of life may be increased in the home-based rehabilitation arm as they will not 
need to attend a cardiac rehabilitation clinic outside of their home.
17.5  Explain why the risks to subjects are reasonable: 
If the study is successful in determining the most effective aspects of cardiac rehabilitation and 
determining whether home-based CR is as effective as center-based CR, future participants in CR 
programs may have an improved quality of life and fewer cardiac events. The risks of particpation are 
relatively minimal to the individual, with potential benefits to society outweighing these risks.
 
18.0
 Data and Safety Monitoring Plan
18.1  Describe the plan for monitoring data and safety 
:
(Help Text updated 9/13)
Study staff will keep active and regular surveillance of the vital status of all subjects enrolled in this 
research study and report any and all adverse events as they occur. Study nurses will conduct an 
extensive initial assessment of all study subjects to determine any exercise risk factors and will maintain 
regular contact with subjects throughout their participation in the study. Serious adverse events that meet 
the reporting requirements set out by the UCSF Committee on Human Research will be reported within five 
working days of awareness.
 
18.2  This study requires a Data and Safety Monitoring Board:
Yes 
No or not sure 
If 
, press 
 to move to the next section of the application.
yes
SAVE and CONTINUE
18.3  If 
, provide rationale:
No
Social/Behavioral research 
Phase I trial 
Treatment IND/Compassionate Use Trial 
Other (explain below) 
If 
 explain:
Other,
Because this study does not include a control group, it will be difficult for a data safety monitoring board to 
determine whether any adverse events are due to study activities. As a result, we will not convene a DSMB 
to monitor this study.
 
19.0
 Confidentiality and Privacy
19.1  Plans for maintaining privacy in the research setting:
Participant data will be maintained per VA Privacy Protocols. Paper consents will be stored in double 
locked cabinets. Electronic data will be on encrypted drive. Use of identifying information will be 
minimized. Phone calls will not be recorded and caregivers who may be involved in the patient's care 
and recipient of patient information will be identified prior to the calls with the patient's consent.
 
Data will not be transferred from VA entities to non-VA entities.
19.2  Possible consequences to subjects resulting from a loss of privacy:

A loss of privacy may result in divulging patient health history and lab data, participation in a clinical 
research study, and personal demographics including insurance status and income. Subjects who 
participate in this study and have their information divulged could potentially experience job loss, loss of 
insurance coverage, or other consequences.
 
19.3  Study data are:
Derived from the Integrated Data Repository (IDR) or The Health Record Data Service (THREDS) at 
SFGH
Derived from a medical record (e.g. APeX, OnCore, etc. Identify source below)
Added to the hospital or clinical medical record
Created or collected as part of health care
Used to make health care decisions
Obtained from the subject, including interviews, questionnaires
Obtained from a foreign country or countries only
Obtained from records open to the public
Obtained from existing research records
None of the above
If 
, identify source:
derived from a medical record
VA CPRS
19.4  Identifiers may be included in research records:
  Yes   
  No
If 
, check all the identifiers that may be included:
yes
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
* Required for studies conducted at the VAMC
19.5  Identifiable information might be disclosed as part of study activities:
 Yes   
 No

If 
, indicate to whom identifiable information may be disclosed:
yes
The subject's medical record
The study sponsor
Collaborators
The US Food & Drug Administration (FDA)
Others (specify below)
A Foreign Country or Countries (specify below)
If 
, specify:
Others
VA regulatory personnel
19.6  Indicate how data are kept secure and protected from improper use and disclosure (check all that 
apply):   NOTE: Whenever possible, do not store subject identifiers on laptops, PDAs, or other 
portable devices. If you collect subject identifiers on portable devices, you MUST encrypt the devices.
Data are stored securely in My Research
Data are coded; data key is destroyed at end of study
Data are coded; data key is kept separately and securely
Data are kept in a locked file cabinet
Data are kept in a locked office or suite
Electronic data are protected with a password
Data are stored on a secure network
Data are collected/stored using REDCap or REDCap Survey
Data are securely stored in OnCore
19.7  Additional measures to assure confidentiality and protect identifiers from improper use and 
disclosure, if any:
Data will be kept on an encrypted network drive.
 
19.8  This study may collect information that State or Federal law requires to be reported to other officials 
or ethically requires action:
  Yes   
  No
Explain:
 
19.9  This study will be issued a Certificate of Confidentiality:
  Yes   
  No
20.0
 Subjects
20.1  Check all types of subjects that may be enrolled:
Inpatients
Outpatients
Healthy volunteers
Staff of UCSF or affiliated institutions

20.2  Additional vulnerable populations:
Children
Subjects unable to consent for themselves
Subjects unable to consent for themselves (emergency setting)
Subjects with diminished capacity to consent
Subjects unable to read, speak or understand English
Pregnant women
Fetuses
Neonates
Prisoners
Economically or educationally disadvantaged persons
Investigators’ staff
Students
Explain why it is appropriate to include the types of subjects checked above in this particular study:
Describe the additional safeguards that have been included in the study to protect the rights and welfare 
of these subjects and minimize coercion or undue influence:
21.0
 Recruitment
21.1  
 Methods (check all that apply):
*
Study investigators (and/or affiliated nurses or staff) recruit their own patients directly in person or by 
phone.
Study investigators recruit their own patients by letter. Attach the letter for review.
Study investigators send a “Dear Doctor” letter to colleagues asking for referrals of eligible patients. If 
interested, the patient will contact the PI or the PI may directly recruit the patients (with documented 
permission from the patient). Investigators may give the referring physicians a study information 
sheet for the patients.
Study investigators provide their colleagues with a “Dear Patient” letter describing the study. This 
letter can be signed by the treating physicians and would inform the patients how to contact the study 
investigators. The study investigators may not have access to patient names and addresses for mailing
Advertisements, notices, and/or media used to recruit subjects. Interested subjects initiate contact 
with study investigators. Attach ads, notices, or media text for review. In section below, please explain 
where ads will be posted.
Study investigators identify prospective subjects through chart review. (Study investigators request a 
Waiver of Authorization for recruitment purposes.)
Large-scale epidemiological studies and/or population-based studies: Prospective subjects are 
identified through a registry or medical records and contacted by someone other than their personal 
physician. (Study investigators request a Waiver of Authorization for recruitment purposes.)
Direct contact of potential subjects who have previously given consent to be contacted for participation 
in research. Clinic or program develops a CHR-approved recruitment protocol that asks patients if they 
agree to be contacted for research (a recruitment database) or consent for future contact was 
documented using the consent form for another CHR-approved study.
Study investigators list the study on the School of Medicine list of UCSF Clinical Trials website or a 
similarly managed site. Interested subjects initiate contact with investigators.
Study investigators recruit potential subjects who are unknown to them through methods such as 
snowball sampling, direct approach, use of social networks, and random digit dialing.
Other
If 
, explain:
Other

21.2  
How, when, and by whom eligibility will be determined:
* 
The clinical nurses responsible for providing cardiac rehabilitation will determine eligibility by applying the 
study inclusion and exclusion criteria at the time patients are referred to cardiac rehabilitation.  
21.3  
How, when, where and by whom potential subjects will be approached:
* 
Eligible patients will be offered standard of care cardiac rehabilitation regardless of whether they wish to 
participate in the study. Most patients will be approached in the hospital (at the bedside). The research 
staff member will explain the benefits of cardiac rehabilitation and offer the patient the opportunity to 
participate in the study. If the patient agrees to participate in the study, a research staff member will 
obtain informed consent. If the patient declines to participate in the study, usual care will continue. If for 
some logistical reason consent cannot be obtained during a patient's hospitalization, and the patient still 
wishes to participate in the study, a member of the research staff will obtain informed consent prior to 
enrollment in the study. No study procedures will be conducted prior to obtaining consent.
 
21.4  * Protected health information (PHI) will be accessed prior to obtaining consent:
 Yes   
 No
22.0
 Waiver of Consent/Authorization for Recruitment 
Purposes
This section is required when study investigators (and/or affiliated 
nurses or staff) recruit their own patients directly.
22.1  
Study personnel need to access protected health information (PHI) during the recruitment process 
* 
and it is not practicable to obtain informed consent until potential subjects have been identified:
Yes 
If 
, a waiver of consent/authorization is NOT needed.
no
22.2  
 A waiver for screening of health records to identify potential subjects poses no more than minimal 
* 
risk to privacy for participants:
Yes 
If 
, a waiver of authorization can NOT be granted.
no
22.3  
Screening health records prior to obtaining consent will not adversely affect subjects' rights and 
* 
welfare:
Yes 
If 
, a waiver of authorization can NOT be granted.
no
22.4  
Check all the identifiers that will be collected prior to obtaining informed consent:
* 
Names
Dates
Postal addresses
Phone numbers

Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
None
Note: HIPAA rules require that you collect the minimum necessary.
22.5  
 Describe any health information that will be collected prior to obtaining informed consent:
*
Health information related to inclusion and exclusion criteria will be collected from the patient's electronic 
medical record.
 
Note: HIPAA requires that you collect the minimum necessary.
22.6  
Describe your plan to destroy the identifiers at the earliest opportunity consistent with the 
* 
research 
 provide a health or research justification for retaining the identifiers, or indicate and 
or
explain that retention is required by law:
All screening PHI will be maintained electronically on VA servers and will be kept indefinitely (and securely) 
until a VA policy on destruction of data is in place.
 
23.0
 Informed Consent
23.1  * Methods (check all that apply):
Signed consent will be obtained from subjects and/or parents (if subjects are minors)
Verbal consent will be obtained from subjects using an information sheet or script
Electronic consent will be obtained from subjects via the web or email
Implied consent will be obtained via mail, the web or email
Signed consent will be obtained from surrogates
Emergency waiver of consent is being requested for subjects unable to provide consent
Informed consent will not be obtained
23.2  
Process for obtaining informed consent:
* 
Informed consent will be obtained during a study interview at the San Francisco VA Medical Center and 
before any study interventions have been initiated. All subjects will have the opportunity to read the 
informed consent and have their questions answered. Participants will be able to decline to participate 
without affecting any of their care or their ability to access cardiac rehabilitation. One copy of the 
consent will be provided to the participant. One copy will be scanned into the EHR per VA regulations. 
One copy will be retained by study staff.

23.3  
How investigators will make sure subjects understand the information provided to them:
* 
Participants will verbalize understanding of the study and be able to describe what will happen during 
the study.
24.0
 Financial Considerations
24.1  Subjects payment or compensation method (check all that apply):
Payments will be (check all that apply):
Subjects will not be paid
Cash
Check
Debit card
Gift card
Reimbursement for parking and other expenses
Other:
Specify 
:
Other
24.2  Describe the schedule and amounts of payments, including the total subjects can receive for 
completing the study. If deviating from recommendations in Subject Payment Guidelines, include 
specific justification below. 
$50 reimbursement for baseline assesment. Paid upon completion of assesment.
$50 reimbursement for 3-month assessment. Paid upon completion of assessment.
$50 reimbursement for 6-month assessment. Paid upon completion of assessment.
The total amount any subject can receive for completing the study is $150
 
24.3  Costs to Subjects:  Will subjects or their insurance be charged for any study procedures?
  Yes   
  No
If 
 describe those costs below, and compare subjects’ costs to the costs associated with alternative 
yes,
care off-study. Finally, explain why it is appropriate to charge those costs to the subjects.
25.0
 CTSI Screening Questions
25.1  
This study will be carried out at one of the UCSF Clinical Research Services (CRS) centers or will 
* 
utilize CRS services. CRS centers are at the following sites:
SFGH Clinical Research Center
Moffitt Adult Clinical Research Center
Moffitt Hospital Pediatrics & NCRC
Mount Zion Hospital Clinical Research Center
Tenderloin Center
CHORI Children's Hospital Pediatrics & Adult Clinical Research Center
Kaiser Oakland Research Unit
SF VA Medical Center Clinical Research Unit
  Please note: Effective 3/1/14, the CRS form will no longer be completed and submitted in iRIS. The 
CRS budget request form can be found at: https://accelerate.ucsf.edu/files/crs
 
/BudgetRequest2015.docx. Follow the instructions on the form to submit.  Even if you click 'Yes' to 

this question, the form will no longer proceed to the Clinical Research Services (CRS) Application 
Form section.
  Yes   
  No
25.2  This project involves community-based research:
  Yes   
  No
25.3  This project involves practice-based research:
  Yes   
  No
26.0
 End of Study Application
26.1  End of Study Application Form   To continue working on the Study 
: Click on the section you need to edit in the left-hand menu. Remember to save 
Application
  
through the entire Study Application after making changes.  If you are done working on the 
: Click Save and Continue. If this is a new study, you will automatically 
Study Application
enter the Initial Review Submission Packet form, where you can attach consent forms or 
other study documents. Review the 
 for a list of required 
Initial Review Submission Checklist
 
attachments.   Answer all questions and attach all required documents to speed up your 
 
approval.