Perceived Social Support, Heart Rate Variability, and Hopelessness in Patients With Ischemic Heart Disease
Conditions: Ischemic Heart Disease
Sponsor: University of Illinois at Chicago

 
 
 
 
Research Protocol: 
Perceived Social Support, Heart Rate Variability, and Hopelessness in Patients with 
Ischemic Heart Disease 
(Hope Beats Study) 
 
NCT: 
NCT05003791 
 
 
Principal Investigator: 
Madison (Buursma) Goodyke, BSN, RN 
PhD Student 
College of Nursing, Department of Biobehavioral Nursing Science 
University of Illinois Chicago 
 
Date created: 9/23/2021 
Reviewed and revised: 2/12/2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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TABLE OF CONTENTS 
Page 
Table of Contents ............................................................................................................ 2 
List of Abbreviations ........................................................................................................ 3 
1.0 Project Summary/Abstract ....................................................................................... 4 
2.0 Objectives/Aims ..................................................................................................... 4 
3.0 Eligibility ................................................................................................................. 5 
3.1 Inclusion Criteria ............................................................................................. 5 
3.2 Exclusion Criteria ............................................................................................ 5 
3.3 Excluded or Vulnerable Populations ............................................................. 5 
4.0 Subject Enrollment ................................................................................................ 5 
5.0 Study Design and Procedures .............................................................................. 6 
6.0 Expected Risks/Benefits ....................................................................................... 8 
7.0 Data Collection and Management Procedures ................................................... 8 
8.0 Data Analysis ......................................................................................................... 8 
9.0 Quality Control and Quality Assurance ............................................................... 9 
10.0 Data and Safety Monitoring .................................................................................. 9 
11.0 Regulatory Requirements ..................................................................................... 9 
11.1 
Informed Consent ......................................................................................... 9 
11.2 
Subject Confidentiality ................................................................................ 10 
11.3 
Unanticipated Problems .............................................................................. 10 
Appendices .................................................................................................................... 12 
 

 
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LIST OF ABBREVIATIONS  
 
HF 
 
 
High frequency 
HIPAA 
 
Health Insurance Portability and Accountability Act 
HRV  
 
Heart rate variability 
IHD 
 
 
Ischemic heart disease 
PHI 
 
 
Protected health information 
PSS  
 
Perceived social support 
QA 
 
 
Quality assurance 
RMSSD 
Square root of the mean of the sum of the squares of differences 
between adjacent RR intervals  
RR 
The interval between normal successive heartbeats  
USPS  
 
United States Postal Service 
 

 
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1.0 
Project Summary/Abstract 
Cardiovascular disease is the leading cause of death worldwide, with ischemic heart 
disease (IHD) the leading cause of cardiovascular mortality. Persons with IHD suffering from 
psychological distress, including hopelessness, are more likely to die from IHD. Following a 
stressful event, the vagus nerve enables activation of either a sympathetic (fight/flight) or 
parasympathetic (rest/digest) response. Heart rate variability (HRV), the beat-to-beat variability 
between normal successive heart beats, is a biomarker of both adaptive and maladaptive 
reactions to stress. Decreased HRV predicts greater risk for morbidity and mortality and is 
associated with poor mental health outcomes in persons with IHD. As stated by polyvagal 
theory, HRV may be influenced by social support. Decreased perceived social support (PSS), a 
social determinant of cardiovascular risk, is predictive of increased morbidity and mortality in 
persons with IHD. Decreased PSS has been associated with hopelessness in patients with 
cancer, but this relationship has not been studied in IHD beyond the applicant’s small pilot study 
of patients with hopelessness. Hopelessness, a negative outlook and sense of helplessness 
about the future, is present in 27-52% of patients with IHD. This is of grave concern, because 
hopelessness is associated with a 3.4 times increased risk of mortality and nonfatal myocardial 
infarction in patients with IHD, independent of depression. This research focuses on 
understanding the biological (HRV) and social (PSS) aspects of hopelessness, with the long-
term goal of developing and testing novel interventions to reduce the adverse effects of 
hopelessness and improve health outcomes in patients with IHD. Participants for this cross-
sectional study will be recruited while hospitalized for an IHD event. Participants will include 
patients who report moderate to severe hopelessness from Dr. Dunn’s NIH-funded study 
(R01NR017649, n = 225); additional patients with minimal to no hopelessness will be recruited 
and enrolled by the applicant (n = 45). Data collection will take place remotely two weeks after 
hospital discharge. Specific aims include: Aim 1) Evaluate the relationship between HRV and 
hopelessness in patients with IHD; Aim 2) Determine the relationship between PSS and 
hopelessness in patients with IHD; and Aim 3) Explore the possible mediating effect of HRV on 
the relationship between PSS and hopelessness in patients with IHD. The outcomes of this 
proposed study and the training plan will prepare the PhD student to launch a program of 
research focused on the biological and social dynamics of symptoms experienced in patients 
with IHD, with a long-term goal of promoting personalized health treatments for persons with 
IHD. 
 
2.0 
Objectives/Aims 
Specific Aims are to:  
Aim 1: Evaluate the relationship between HRV and hopelessness in patients with IHD.  
Hypothesis: Higher levels of HF HRV will be associated with lower levels of hopelessness.  
Aim 2: Determine the relationship between PSS and hopelessness.  
Hypothesis: Higher levels of PSS will be associated with lower levels of hopelessness.  
Aim 3: Explore the possible mediating effect of HRV on the relationship between PSS and 
hopelessness.  
Hypothesis: HF HRV will mediate the relationship between PSS and hopelessness. 

 
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* As an extension of Dr. Dunn’s NIH-funded study 
(https://clinicaltrials.gov/ct2/show/NCT03907891), data collected from patients with IHD who 
report moderate to severe hopelessness will be analyzed to examine the aims. The PI of this 
study (Hope Beats) will also collect and analyze data from patients with minimal to no 
hopelessness. The data collected from patients reporting minimal to no hopelessness are 
presented in this clinical trial registration. 
 
3.0 
Eligibility 
 
3.1 Inclusion Criteria 
• 
Eligibility criteria for hopelessness screening include: Adults ≥ 18 years old; 
diagnosed with myocardial infarction, unstable angina, or who undergoing 
percutaneous coronary intervention or coronary artery bypass graft surgery; 
speak and read English; and can complete the screening instrument.  
 
3.2 Exclusion Criteria 
• 
The following exclusion criteria are in place because they alter heart rate 
variability: having a pacemaker or implanted cardioverter-defibrillator, chronic 
arrhythmia, history or current valvular disease, history of organ transplant, 
current use of immunosuppressive medications, or diabetic autonomic 
insufficiency. Although research conducted in 2016 identified HRV diminishing 
with age when controlling for disease and medication use, more recent research 
has identified no relationship between HRV and age. A study of healthy 
individuals, controlling for other health conditions, did not find any relationship 
between resting HRV and age in adults older than 40. Another study of healthy 
participants identified no significant difference in resting HRV between persons in 
the age group 40-49 compared to 50-59. Because the median age for a male 
with IHD is 65 years and for females is 70 years, the age range of 40-80 years 
was chosen to be representative of the IHD population and to mitigate the 
confounding effect of age on HRV. 
 
3.3 Excluded or Vulnerable Populations 
• 
Only English-speaking patients are eligible to enroll in the study, because not all 
instruments are readily available in languages other than English. 
 
4.0 
Subject Enrollment 
The PI will screen potentially eligible patients over the phone or in person. Screening will 
include asking patients if they meet any of the exclusion criteria described above. Patients who 
are eligible for enrollment after screening will be asked by the PI to participate in the proposed 
research. The PI will read through a script to describe the study. If a patient agrees to 
enrollment in the study, written consent will be obtained. If the participant is enrolled after 
hospital discharge, they will be sent a link via email or text message, which will take them to the 
REDCap e-consent page, where they will provide an electronic signature. After the electronic 
signature is accepted and confirmed, a copy of the signed e-consent will be sent to the patient 
by email and/or postal mail and a copy will be saved in the REDCap database.  

 
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5.0 
Study Design and Procedures 
Human Subjects Involvement, Characteristics, and Design 
The proposed study uses a cross-sectional design. Patients enrolled in Dr. Dunn’s study 
(until March 3/6/2023) with moderate to severe hopelessness and the additional 45 patients 
recruited who screen to have minimal to no hopelessness by the PhD student will be included in 
the analysis of Aim 2. Aims 1 and 3 will include patients from Dr. Dunn’s study who meet the 
stated inclusion and exclusion criteria for the proposed study, in addition to the 45 patients who 
report minimal to no hopelessness. Both groups of patients (moderate to severe hopelessness 
and minimal to no hopelessness) will complete the same hopelessness screening in the hospital 
and the Week 2 data collection measures.  
 
Data Collection Procedures. Study participants will receive a study package by USPS mail 
two weeks after hospital discharge plus or minus two days and will also receive an instructional 
phone visit at Week 2. Study package materials will include a Polar H7 heart rate monitor, 
ActiGraph wGT3X-BT (to link to the Polar monitor for HRV data collection), written instructions 
for HRV measurement, hard copies of questionnaires (to read along with during the data 
collection phone call), instructions to return the monitors, and a prepaid return envelope. 
Participants will also be sent a secure link via text or email to an instructional video depicting 
verbal and visual demonstration of proper placement for the Polar H7 heart rate monitor and 
ActiGraph wGT3X-BT. The PI will call the participant once a mail delivery notice has been 
received. During the call, the PI will confirm proper placement of the two monitors used to 
measure HRV and answer any questions. All data collection will occur at Week 2. Study 
measures and their characteristics can be found in Table 1.  
Heart Rate Variability Procedures. At Week 2, participants will be instructed to place the 
Polar H7 heart rate monitor around the center of their chest, in contact with the skin, and the 
ActiGraph wGT3X-BT around their waist, according to directions outlined in the written 
instructions provided and as demonstrated in the instructional video and practiced with the 
applicant over the phone. Participants will be informed that the monitors are used to gather data 
about their body at rest. The Polar H7 heart rate monitor connects to the ActiGraph with 
Bluetooth® wireless technology so that the interval between normal heart beats (RR data) can 
be transferred to csv files for analysis. The HRV protocol will take place during a 10-minute time 
period on two consecutive days, to ensure at least one 10-minute time frame of usable data. 
Participants will be instructed to place the monitors first thing in the morning after they wake up 
and empty their bladder. Once the monitors are placed, participants will be instructed to lay 
supine quietly for 10 minutes and avoid moving or using any devices or watching tv. The 
standardized HRV protocol improves reliability of the HRV measurement because control of 
extraneous variables is maintained. Respirations will not be controlled because this can 
artificially increase HF HRV. The gold standard amount of time for a short-term HRV recording 
is 5 minutes. The 5 minutes of the recording with the least amount of artifact will be used for 
analysis. After 10 minutes of recording are completed, the heart rate monitor and ActiGraph will 
be removed. After the participant completes the 10-minute HRV measurements on two 
consecutive days, they will be asked to return the monitors in a prepaid envelope that will be 

 
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picked up from their mailbox by USPS and returned to the PI, mitigating any exposure to 
COVID-19. 
Phone Visit to Complete Questionnaires. After completion of the HRV measurement 
instructional phone visit, participants will receive their Week 2 data collection visit. Participants 
in the PI’s study will receive their phone visit from the PI. The PI will follow a script for data 
collection. Data collection interviews will take on average 20 minutes. During the phone visit, the 
data collector/PhD student will first ask how HRV measurement went that morning and remind 
participants to complete the measurement the following morning. Participants will then be asked 
to complete the four questionnaires indicated at the Week 2 timepoint in Table 1 (demographic 
questionnaire, State-Trait Hopelessness Scale, ENRICHD Social Support Inventory, and Patient 
Health Questionnaire-9). Demographic data are being collected to describe the sample and 
determine if these variables are confounders. Depressive symptoms are being measured as a 
potential covariate because of the known association between hopelessness and depression.16 
Upon completion of data collection, participants will be compensated $20 for their time and 
commitment to the study. This is the same amount that patients enrolled in Dr. Dunn’s study 
receive after their Week 2 visit. All questionnaire and electronic medical record data will be 
logged directly into REDCap using a secure electronic tablet. Data from medical records will be 
collected within 2 weeks of the participant’s hospital discharge. 
Measures. Characteristics of study measures appear in Table 1. 
Table 1. Study Measures, Concepts, Variables, & Psychometric Properties 
Measure 
Concept  
Time-
point 
#  
Items 
Range 
Description  
Reliability/ 
Validity 
Polar H7 
Heart Rate 
Monitor 
Heart rate 
variability 
Week 2 
NA 
Varies 
by 
domain 
• Monitor is worn across patient’s chest to 
provide heart rate data 
• Monitor has Bluetooth capabilities with 
ActiGraph WGT3X-BT so RR data can be 
transferred to csv files for analysis 
Strong correlation 
with ECG for 
measuring short-
term HRV (r=0.99) 
Demographic 
Questionnaire  
 
Demographics  
Week 2  
17 
NA 
• Age, sex, race, smoking status, ability to 
participate in physical activity, history of 
depression, marital status, education level, 
insurance status, employment status 
NA 
State-Trait 
Hopelessness 
Scale (STHS) 
State and trait 
hopelessness  
Week 2 
23 
 
1-4 
• 4-point Likert-type scale: 1 = strongly disagree, 
4 = strongly agree 
• Differentiates state and trait hopelessness 
• Adding the item scores and dividing by the 
number of items provides a total score for each 
subscale 
• Reliability:  
state a = 0.87,  
trait a = 0.87 
• Concurrent and 
predictive validity 
with IHD patients 
ENRICHD 
Social Support 
Inventory 
(ESSI) 
Perceived 
social support  
Week 2 
5 
5-25 
• 5-point Likert-type scale: 1 = none of the time, 
5 = all of the time 
• Items summed for score: higher scores 
indicate greater perceived social support 
Found valid and 
reliable in patients 
with IHD 
Patient Health 
Questionnaire
-9 (PHQ-9) 
 
Depressive 
symptoms  
Week 2 
9 
0-27 
• Measures depressive symptom severity 
• Items scored on a Likert-type scale from 0 = 
not at all to 3 = nearly every day and summed 
for a total score  
• Separate cognitive and somatic depressive 
symptoms dimensions have been validated in 
patients with IHD 
Internal reliability 
and criterion and 
construct validity 
previously 
established 
Medical 
Records 
Abstraction 
Form  
Clinical 
characteristics  
Hospital 
5 
NA 
• Two purposes: 1) To confirm eligibility and 2) 
To collect diagnoses, cardiovascular 
procedures, and admission height and weight 
NA 
 
 

 
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6.0 
Expected Risks/Benefits 
Potential Risks. There is minimal likelihood or seriousness of potential risks to participants. 
There are no identified physical, legal, or financial risks. Participants may become fatigued 
during completion of the study questionnaires and HRV monitoring and may feel apprehensive 
or distressed sharing information, but there is low probability of this and a low level of 
seriousness. There is potential for loss of confidentiality; however, procedures to protect against 
this risk will be put in place, as described below. Patients will continue to seek and receive 
standard medical care for their IHD diagnosis; therefore, any health care problems that may 
arise will be referred to their health care provider. 
 
Protections Against Risk: The PI who will conduct remote data collection (by phone) 2 
weeks after patients’ hospital discharge, has been trained to assess for potential fatigue or 
apprehension of participants. If participants exhibit apprehension, they will be given the option to 
discuss this, to complete the questionnaires at another time, to be referred to their physician for 
further counseling follow-up, or to discontinue the study. These are all expected to be effective 
approaches. Patients will additionally be informed that they can withdraw from the study at any 
time, without loss of benefits they would otherwise be entitled to and without penalty to their 
health care. There is no risk for incidental findings. 
 
7.0 
Data Collection and Management Procedures 
The Polar H7 heart rate monitor connects to the ActiGraph with Bluetooth® wireless 
technology so that the interval between normal heart beats (RR data) can be transferred to 
comma-separated value files for HRV analysis. The RR data will be exported from ActiLife and 
uploaded and analyzed in Kubios HRV Software (a secure HRV analysis software for scientific 
research) to generate the time, frequency, and nonlinear domain measures of HRV. Patient 
numeric codes will be used when analyzing the data; no patient identifiers will be used. All 
questionnaire and electronic medical record data will be logged directly into the REDCap 
database via Web interface. The web server synchronizes uploaded files to an alternate location 
and is backed up daily. De-identified data sets for analyses will be created by importing data 
from REDCap into the statistical programs R and SPSS.  
 
8.0 
Data Analysis 
Data Analysis for Each Aim. Confirmation of the internal reliability of scales will be 
assessed using Cronbach’s alpha. The following analyses will be used for each aim. 
Aim 1: Kubios HRV software will be used to generate the HRV data for time, frequency, and 
nonlinear domain analyses. Kubios uses a threshold-based artifact correction algorithm that 
compares RR beats against a local average interval. The lowest level threshold that accurately 
detects artifact without overcorrecting normal beats will be used for each recording. Recordings 
with >5% artifact will not be used in analysis because even a small number of corrected ectopic 
or missing beats can have a great influence on short-term HRV results. To prevent the issue of 
not having useable data for a participant, participants are instructed to obtain the measurement 
at two separate timepoints. The recording with the least artifact will be used. The primary 
analysis for Aim 1 involves regressing hopelessness levels on HRV, after controlling for relevant 
demographic (e.g., age, sex) and other covariates (e.g., time of day, deviation from protocol, 

 
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etc.), using a multiple regression framework. All covariates as well as hopelessness and HRV 
levels will be normalized using transformations as needed; to ensure model robustness to 
variable distributions we will also apply rank-based approaches and bootstrapping of standard 
errors. As part of a sensitivity analysis, we will fit these same models within the two subgroups: 
those with moderate to severe hopelessness versus minimal to no hopelessness. Additional 
subgroup analyses will be completed to evaluate potential differences between sexes and type 
of IHD event and will include adding interaction terms to the models between sex or type of IHD 
event and HRV. 
Aim 2: The STHS and ESSI scores for all patients in Dr. Dunn’s study enrolled until 3/6/23 
and the 45 patients that will be recruited for the proposed application will be pooled to assess 
the relationship between hopelessness and PSS. Again, we will analyze the relationship using a 
multiple regression framework regressing STHS on ESSI and controlling for relevant 
demographics (see previous paragraph). A secondary analysis will add depression to the model 
to ensure that any relationship between STHS and ESSI is not better explained by depression. 
Additional secondary analyses will follow as noted above with subgroup analyses by level of 
hopelessness and interactions for sex and type of IHD event with ESSI.  
Aim 3: Finally, we will follow the approach of Shrout and Bolger to evaluate the potential for 
HRV to be acting as a mediator of the PSS and hopelessness relationship. As suggested by 
Shrout and Bolger, bootstrapping will be used to determine the significance of the mediation 
effect. 
Missing Data. Previous analyses using several of the same instruments in similar 
populations have yielded low missing data rates (< 1-2%). These individuals are typically not 
included in the analysis. For scales such as the STHS and PHQ-9, a regression-based 
imputation procedure to predict single or multiple missing items will be used, assuming data are 
missing completely at random.  
 
9.0 
Quality Control and Quality Assurance 
 
The PI is responsible for collecting and analyzing the data for the proposed study. HRV 
data will be analyzed as soon as monitors are returned to ensure proper data capture. 
Participants that do not have an appropriate HRV recording will be asked to wear again. The PI 
will ensure all data is entered accurately during each visit.  
 
10.0 Data and Safety Monitoring 
Institutional Review Board (IRB) approval was received from both the sponsoring institution 
and recruitment site hospital before the study began. 
 
11.0 Regulatory Requirements 
11.1 Informed Consent  
The recruiting hospital is responsible for recruiting, consenting and screening eligible 
patients (i.e., those who are screened as hopeless) for Dr. Dunn’s study. Interested patients will 
provide verbal consent for the hopelessness screening, including a HIPAA waiver. The screening 
consent includes permission for review of the patient’s medical records to collect patient 

 
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characteristics and comorbidities. Those patients who do not qualify for Dr. Dunn’s study will be 
referred to the PI for assessment of eligibility for the PI’s study. 
Patients who do not meet the hopelessness criteria for Dr. Dunn’s study (they have minimal 
or no hopelessness) will be approached by the PI to discuss possible enrollment in the 
proposed study. The PI will screen patients over the phone or in person to ensure they do not 
meet any of the study exclusion criteria. If a patient is eligible and agrees to enrollment in the 
study, written consent will be obtained. The consent will explain the study, risks, benefits, 
voluntary nature of participation, and the patient’s right to discontinue participation at any time 
without consequences. If the participant is enrolled after hospital discharge, they will be sent a 
link via email or text message, which will take them to the REDCap e-consent page, where they 
will provide an electronic signature. After the electronic signature is accepted and confirmed, a 
copy of the signed e-consent will be sent to the patient by email and/or postal mail and a copy 
will be saved in the REDCap database.  
11.2 Subject Confidentiality  
Confidentiality: The confidentiality of participants and their data will be protected in the 
following ways: 1) no identifying information will be used as sources of identification for 
participants; 2) at time of enrollment, the REDCap system will assign each patient a four-digit 
numerical code, which will become the identifier of records for all patients; 3) consent forms will 
be kept double-locked separate from research data; 4) contact information needed for USPS 
shipments and phone visits will be entered and stored on a secure dedicated server with 
appropriate firewalls using the REDCap system; 5) all electronic tablets used to collect and send 
data will be double-password-protected; 6) electronic copies of completed questionnaires will be 
stored on a secure dedicated server with appropriate firewalls using the REDCap system; 7) 
dissemination of research data will be done in aggregate form only; and 8) hospital name and 
city will be omitted in all reports and presentations.  
11.3 Unanticipated Problems 
 
Participants will be queried about potential adverse events and unanticipated problems as 
defined below:  
 
Adverse event. An adverse event will be defined in this research as any untoward or 
unfavorable medical occurrence in a study participant, including any abnormal symptom 
(including psychological), sign (including physical), or disease temporally associated with the 
participant’s involvement in the research, whether or not considered related to participation in 
the research. Adverse events in this study will include, but not be limited to, death, cardiac 
restenosis (myocardial infarction, revascularization with coronary artery bypass surgery or 
percutaneous coronary intervention), or suicidal ideation.  
 
Unanticipated problem. An unanticipated problem will be defined in this research as any 
incident, experience, or outcome that meets all of the following criteria: 1) unexpected (nature, 
severity, or frequency) given the research procedures that are described in the research 
protocol and informed consent, and given the characteristics of the study population; 2) related 

 
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or possibly related (reasonable possibility that the problem may have been caused by study 
procedures) to participation in the research; and 3) suggests that the research places 
participants or others at a greater risk of harm (including physical, psychological, economic, or 
social harm) than was previously known or recognized. Unanticipated problems in this study will 
include, but not be limited to, a breach of confidentiality. 
 
 
Adverse events and unanticipated problems will be monitored in several ways during the 
implementation of the study protocol. First, adverse events and unanticipated problems will be 
monitored by the PI during data collection. The PI will document any adverse events and 
unanticipated problems reported to them by participants and report these immediately to their 
advisor. Second, all patients will be provided a toll-free phone number to contact the PI directly 
if they have any issues or concerns to report 
 
All adverse events and unanticipated problems will be reported to the PI’s advisor within 
24 hours. If the advisor evaluates the adverse events and unanticipated problems to be 
moderate or serious, she will notify the PI and convene the SMC. All unanticipated problems or 
serious adverse events that may be related to the study protocol will be reported by the PI to the 
university IRB and hospital IRB within 48 hours of the committee meeting. The PI will 
immediately respond and closely monitor any reported adverse events and unanticipated 
problems. The PI will enter all adverse events and unanticipated problems into the study 
database. Regardless of whether an adverse event or unanticipated problem is related to the 
study protocol, the participant’s primary care provider will be notified of an event if it affects the 
patient’s clinical status.  
 
 
 
 

 
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APPENDICES 
Appendix A 
 
Screening, Recruitment, and Enrollment 
A1 
 
Eligibility Screening for Hopelessness 
 
A2 
Exclusion criteria for Enrollment in PI’s Study 
 
Appendix B 
 
Data Collection Script 
B1 
 
Week 2 Data Collection Script 
Appendix C 
 
Participant Documents 
C1 
 
Written Instructions to Complete Heart Rate Variability 
Measurement 
 
C2 
Directions to Return Monitors after Heart Rate Variability 
Measurement 
 
Appendix D 
 
Data Collection Instruments 
D1 
 
State-Trait Hopelessness Scale 
 
D2 
ENRICHD Social Support Instrument 
 
D3 
Demographic Instrument  
 
D4 
Patient Health Questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix A 
Screening, Recruitment, and Enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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A1: Eligibility Screening for Hopelessness 
 
Indicate yes or no whether the following inclusion criteria are met for the study: 
Inclusion Criteria 
 
Yes 
No 
≥18 years old 
 
 
 
Diagnosed with MI, unstable angina, who underwent percutaneous 
coronary intervention (PCI) or coronary artery bypass graft (CABG) 
surgery 
 
 
Speaks and reads English 
 
 
 
Can complete the screening instrument 
 
 
 
 
If “yes” to all the above criteria, patient is eligible to be screened for hopelessness (see 
state scale of State-Trait Hopelessness Scale on next page)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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State Hopelessness: Screening and Scoring 
 
Today (Right now)… 
 
1. Today, it is difficult for me 
to imagine my future.   
 
Strongly 
disagree 
1 
 
Disagree 
 
2 
 
Agree 
 
3 
 
Strongly agree 
 
4 
 
2. Today, I believe I cannot 
make a difference.   
                      
 
Strongly 
disagree 
1 
 
Disagree 
 
2 
 
Agree 
 
3 
 
Strongly agree 
 
4 
 
3. Today, I believe that things 
will improve. 
 
 
Strongly 
disagree 
4 
 
Disagree 
 
3 
 
Agree 
 
2 
 
Strongly 
agree 
1 
 
4. Today, I believe I am 
powerless to change my 
future.    
 
Strongly 
disagree 
1 
 
Disagree 
 
2 
 
Agree 
 
3 
 
Strongly agree 
 
4 
 
5. Today, I see my future as 
gloomy.        
 
 
Strongly 
disagree 
1 
 
Disagree 
 
2 
 
Agree 
 
3 
 
Strongly agree 
 
4 
 
6. Today, I believe I will 
accomplish what I set out to 
do.    
 
Strongly 
disagree 
4 
 
Disagree 
 
3 
 
Agree 
 
2 
 
Strongly 
agree 
1 
 
7. Today, I believe I can help 
improve things.  
                        
 
Strongly 
disagree 
4 
 
Disagree 
 
3 
 
Agree 
 
2 
 
Strongly 
agree 
1 
 
8. Today, I feel giving up would 
be easier.    
                           
 
Strongly 
disagree 
1 
 
Disagree 
 
2 
 
Agree 
 
3 
 
Strongly agree 
 
4 
 
9. Today, I believe I can 
overcome obstacles.   
                                                        
 
Strongly 
disagree 
4 
 
Disagree 
 
3 
 
Agree 
 
2 
 
Strongly 
agree 
1 
 
10. Today, things will not work out 
as I would like.   
           
 
Strongly 
disagree 
1 
 
Disagree 
 
2 
 
Agree 
 
3 
 
Strongly agree 
 
4 
 
 

 
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Steps to score:  
1) Add 10 item scores, to get a total (NOTE that reverse-scored items have different values in bold 
above).  TOTAL SCORE = ________ Divide total by 10 to get a final score.  FINAL SCORE = 
_______ 
3) Repeat steps 1 and 2 to confirm final score  
4) If FINAL SCORE is 1.8 or greater, patient is eligible for the Dr. Dunn’s study. If FINAL SCORE is less 
than 1.8, patient is eligible for the student’s study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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A2: Exclusion Criteria for Enrollment in PI’s Study 
 
Indicate yes or no whether the following exclusion criteria are met for the study: 
 
Exclusion Criteria 
 
Yes 
No 
Younger than 40 or older than 80 years of age 
 
 
 
Has a pacemaker or implanted cardioverter-defibrillator 
 
 
 
Has a chronic arrhythmia 
 
 
 
History of or current valvular disease  
 
 
 
History of organ transplant 
 
 
 
Current use of immunosuppressive medications  
 
 
 
Diagnosed with diabetic autonomic insufficiency  
 
 
 
 
If “no” to all the above criteria, patient is eligible to enroll in the PI’s study  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix B 
Data Collection Script 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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B1: Week 2 Data Collection Script 
 
Hello Mr./Ms./Mrs. ______________________, 
 
My name is __________ and I am an investigator for the research project that you enrolled in 
during your hospital stay. How are you doing today? 
 
During this call, I will instruct you on how to wear the two monitors that were shipped to you and 
I will have you complete some questionnaires with me. This visit typically takes 15-20 minutes.  
 
When our team talked with you in the hospital, they asked your permission to audio record my 
session with you today. It will be used to give me feedback on how I do. Is that OK? 
 
If Yes: Thank you. To ensure your confidentiality, I will no longer be using your name. 
If No: Proceed as usual 
 
Heart Rate Variability 
To start, I will assist you in placing the two monitors that were recently shipped to you. I will 
need you to place these monitors first thing in the morning and wear them for 10 minutes on two 
consecutive days. The black monitor links to the red monitor to give us information about your 
body at rest.  
 
We ask that after you wake up, use the restroom, and then place the monitors and wear them 
for 10 minutes. In the bag you will find the two monitors. The monitor labeled Polar will need to 
be worn around your chest and in contact with your skin. Please open the ultrasound gel in the 
bag and place some gel on the inside part of the Polar monitor. This helps it connect better with 
your skin. Next, place the monitor around your chest and make sure it is tight enough so that it 
does not move. The piece that has Polar written on it should be in the front center of your chest. 
Next, place the red monitor around your waist with the red monitor centered over your right 
thigh. A blue light should flash on the red activity monitor when both monitors are on correctly. If 
a blue light is not flashing, use your hands to warm the monitor around your chest until the blue 
light flashes. 
 
Once the monitor is flashing blue, I will need you to lay flat on your back for 10 minutes. During 
this time, I ask that you remain silent and still. The monitors should be placed first thing in the 
morning, after you use the restroom, for two days in a row.  
 
Questionnaires 
We will now complete the questionnaires together. Please find the hard copy of the 
questionnaires that were shipped to you so that you can read along. To complete the 
questionnaires, I will read each question to you and have you state your answer. I will chart your 
answers in our computer system. Do you have any questions before we begin? 
 

 
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Demographics and Characteristics 
The first questionnaire will have you answer questions about yourself. (Ask patient the 
questions in questionnaire and chart answers in REDCap) 
 
Self-Assessment Questionnaire (Hopelessness) 
For the next questionnaire, please note that the first set of questions asks how you feel “today 
(right now)”, and the second set of questions asks how you feel “typically (over time). Also note 
that some of the questions are worded in a positive manner, and others are worded in a 
negative manner”. (Ask patient the questions in questionnaire and chart answers in REDCap) 
 
Suicidal Ideation Screening 
To be completed only if participant scores 1.8 or higher on the self-assessment questionnaire 
The next few questions I ask will be used to assess your safety. (Complete suicide ideation 
questions with patient and following instructions in the virtual suicide protocol based on patient 
risk level). 
 
Patient Health Questionnaire (PHQ-9) 
We will move on to the next questionnaire. Over the last 2 weeks, how often have you been 
bothered by any of the following problems? (Ask patient the questions in questionnaire and 
chart answers in REDCap) 
 
Enriched Social Support Instrument 
The next set of questions assesses how you view your social support. The scale ranges from 
none of the time to all of the time. (Ask patient the questions in questionnaire and chart answers 
in REDCap) 
 
Serious Adverse Events and Adverse Events 
At the end of every visit, I like to check in and make sure you have not experienced any of the 
following since the research staff talked with you in the hospital or after your discharge home. 
(Complete questions). 
 
Return Monitors and Compensation 
Thank you so much for your time today! Please remember to place the two monitors in the 
prepaid return envelope. You can place the envelope in your mailbox and the postal service will 
pick it up. Once I receive the returned monitors, I will send you $20 to thank you for participating 
in the study. 
 
Do you have any questions about how to return the monitors or any other questions about the 
study? 
 
Thank you for participation in the study! 
 

 
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Appendix C 
Participant Documents 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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C1: Written Instructions to Complete Heart Rate Variability Measurement 
 
Placement of Two Monitors 
 
Thank you for your participation in our research study. When you receive this package, 
please give me a call and I will instruct you on how to wear the monitors for the study. The 
instructions below describe the same process I will guide you through over the phone. 
Please complete your wearing of the two monitors the first time on the morning after you 
receive the package. We ask that after you wake up, use the restroom, and then place the 
monitors and wear them for 10 minutes. In the bag you will find the two monitors. The monitor 
labeled Polar will need to be worn around your chest and in contact with your skin. Please open 
the ultrasound gel in the bag and place some on the inside part of the Polar monitor. This helps 
it connect better with your skin. Next, place the monitor around your chest and make sure it is 
tight enough so that it does not move. The piece that has Polar written on it should be in the 
front center of your chest. Next, place the red monitor around your waist. The two monitors 
should be worn as shown in the image below. A blue light should flash on the red activity 
monitor when both monitors are on correctly. If a blue light is not flashing, use your hands to 
warm the monitor around your chest until the blue light flashes. 
Once both monitors are on correctly, please find a spot in your house where you feel 
comfortable lying flat on your back for 10 minutes, such as your bed or a couch. While lying 
down, please remain silent and try not to move for the 10 minutes. Once the 10 minutes is done, 
you can remove both monitors.  
 
Complete this same process again the next morning. After you have worn the two monitors two 
times for 10 minutes, you can remove them a final time and place them in the prepaid return 
envelope. 
 
 
 
 
 
 
 
 
 
 
             
Figure showing proper monitor placement. 
 
Thank you! 
 
 
 
R 
L 

 
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C2: Directions to Return Monitors after Heart Rate Variability Measurement 
 
Directions to Return 2 Monitors to Research Staff 
 
After you have worn the 2 monitors for 10 minutes on two consecutive days and 
completed your phone visit with a data collector, please place the monitors in the 
return envelope. Shipping has been prepaid and the US Postal Service will pick 
up the envelope from your mailbox. 
 
After you complete your phone visit with a data collector and research staff 
receive the returned monitors, you will be sent $20 for completing the study.  
 
Please do not hesitate to call with any questions. 
 
Thank you for your participation in the study! 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix D 
Data Collection Instruments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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D1: State-Trait Hopelessness Scale 
 
Self-assessment (State-Trait Hopelessness) Scale 
Part 1 of 2 
 
DIRECTIONS: A number of statements, which people may use to describe their thoughts, are given 
below. Read each statement and then circle the response to the right of the statement that best describes 
how you are thinking today (right now). There are no right or wrong answers. All of your information 
will be kept confidential.  
 
Today (Right now)… 
 
1. Today, it is difficult for me to 
imagine my future.   
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
2. Today, I believe I cannot make a 
difference.   
                      
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
3. Today, I believe that things will 
improve. 
 
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
4. Today, I believe I am powerless to 
change my future.    
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
5. Today, I see my future as gloomy.   
 
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
6. Today, I believe I will accomplish 
what I set out to do.    
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
7. Today, I believe I can help 
improve things.  
                        
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
8. Today, I feel giving up would be 
easier.    
                           
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
9. Today, I believe I can overcome 
obstacles.   
                                                        
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
10. Today, things will not work out 
as I would like.   
           
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
Self-assessment (State-Trait Hopelessness) Scale 

 
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Part 2 of 2 
 
DIRECTIONS: A number of statements, which people may use to describe their thoughts, are given 
below. Read each statement and then circle the response to the right of the statement that best 
describes how you typically think—or how you have thought over the years. There are no right or 
wrong answers. All of your information will be kept confidential.  
 
Typically (Over the years)… 
 
1. Typically, things do not work out as 
I would like.                     
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
2. Typically, I believe I can overcome 
obstacles.  
 
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
3. Typically, I see myself as fortunate.
 
 
 
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
4. Typically, I see my future as 
gloomy.   
 
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
5. Typically, negative things seem to 
happen to me.                    
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
6. Typically, it is difficult for me to 
imagine my future.   
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
7. Typically, I believe I can help 
improve things. 
 
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
8. Typically, I feel giving up would be 
easier.    
 
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
9. Typically, I believe I will 
accomplish what I set out to do.    
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
10. Typically, I believe that things will 
improve. 
 
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
11. Typically, I believe I cannot make a 
difference.                        
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
12. Typically, I doubt that anything is 
worthwhile. 
 
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
13. Typically, I believe I am powerless 
to change my future.    
 
Strongly 
disagree 
 
Disagree 
 
Agree 
 
Strongly agree 
 
 
D2: ENRICHD Social Support Instrument 

 
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5-item ENRICHD Social Support Instrument 
 
1 
Is there someone available to 
whom you can count on to 
listen to you when you need to 
talk? 
none of 
the time  
a little of 
the time  
some of 
the time  
most of 
the time  
all of the 
time  
2 
Is there someone available to 
you to give you good advice 
about a problem? 
none of 
the time  
a little of 
the time  
some of 
the time  
most of 
the time  
all of the 
time  
3 
Is there someone available to 
you who shows you love and 
affection? 
none of 
the time  
a little of 
the time  
some of 
the time  
most of 
the time  
all of the 
time  
4 
Can you count on anyone to 
provide you with emotional 
support (talking over problems 
or helping you make a difficult 
decision) 
none of 
the time  
a little of 
the time  
some of 
the time  
most of 
the time  
all of the 
time  
5 
Do you have as much contact 
as you would like with 
someone you feel close to, 
someone in whom you can 
trust and confide in? 
none of 
the time  
a little of 
the time  
some of 
the time  
most of 
the time  
all of the 
time  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
D3: Demographic Instrument 
 

 
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Demographics 
 
1. What is your age in years?                                                 
2. What is your sex?  
(1) Female  
(2) Male  
 
3. Are you of Hispanic or Latino origin?  
(1) Yes  
(2) No  
 
4. What is your race?  
(1) White  
(2) Black/African American  
(3) American Indian or Alaska Native  
(4) Native Hawaiian or other Pacific Islander Asian  
(5) Other ___________  
 
5. What is your marital status?  
(1) Married  
(2) Separated  
(3) Divorced  
(4) Widowed  
(5) Never been married  
 
6. Have you ever been diagnosed or treated for depression?  
(1) Yes  
(2) No  
 
7. What is the highest grade of school or year of college you completed?  
(1) Eighth grade or less  
(2) Some high school  
(3) High school graduate  
(4) Some college  
(5) College graduate (bachelors)  

 
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(6) Some post-graduate college work (masters, doctoral)  
(7) Graduate with masters- or doctoral-level degree  
 
8. What is your current job status?  
(1) Employed full-time  
(2) Employed part-time  
(3) Retired  
(4) Disabled or unable to work  
(5) Student  
(6) Other (please list) _____________ 
 
9. What type of health insurance do you have?  
(1) Medicare  
(2) Medicaid  
(3) Government VA  
(4) Employer provided  
(5) Privately purchased  
(6) No health insurance 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
D4: Patient Health Questionnaire 
 

 
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Patient Health Questionnaire (PHQ-9) 
 
 
 
1. Little interest or pleasure in doing 
things  
not at all  
several 
days  
more than 
half the days  
nearly 
every day  
2. Feeling down, depressed or hopeless  not at all  
several 
days  
more than 
half the days  
nearly 
every day  
3. Trouble falling or staying asleep, or 
sleeping too much  
not at all  
several 
days  
more than 
half the days  
nearly 
every day  
4. Feeling tired or having little energy  
not at all  
several 
days  
more than 
half the days  
nearly 
every day  
5. Poor appetite or overeating  
not at all  
several 
days  
more than 
half the days  
nearly 
every day  
6. Feeling bad about yourself, or that 
you are a failure or have let yourself or 
your family down 
not at all  
several 
days  
more than 
half the days  
nearly 
every day  
7. Trouble concentrating on things, 
such as reading the newspaper or 
watching television  
not at all  
several 
days  
more than 
half the days  
nearly 
every day  
8. Moving or speaking so slowly that 
other people could have noticed?  Or 
the opposite - being so fidgety or 
restless that you have been moving 
around a lot more than usual.  
not at all  
several 
days  
more than 
half the days  
nearly 
every day  
9. Thoughts that you would be better 
off dead or of hurting yourself in some 
way  
not at all  
several 
days  
more than 
half the days  
nearly 
every day  
10. If you checked off any problems, 
how difficult have these problems 
made it for you to do your work, take 
care of things at home, or get along 
with other people?  
not 
difficult at 
all 
somewhat 
difficult 
very difficult  
extremely 
difficult