Heart Health Buddies: Peer Support to Decrease Cardiovascular Risk (CDA 13-263)
Phase: NA
Conditions: Cardiovascular Disease
Sponsor: VA Office of Research and Development

 
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Title: Heart Health Buddies: Peer Support to Decrease CVD Risk 
Principal Investigator: Karen Goldstein, MD MSPH 
Co-Investigators: Eugene Oddone, MD MHS; Maren Olsen, PhD 
 
Purpose. This intervention will use a hybrid reciprocal peer support and peer coach 
model to initiate and sustain healthy behavioral changes. Veterans who are at-risk for 
cardiovascular disease (CVD) will be enrolled in the study and paired with another 
Veteran to receive and provide social support around engaging in CVD risk reduction 
behaviors. Enrolled participants will be offered a series of group sessions focused on 
CVD risk reduction goal setting and action plan development. Between group sessions, 
peer partners will be asked to have weekly calls to discuss action plan challenges, 
explore options for problem solving, and provide encouragement and accountability for 
personal goals. Participants who do not engage in the group sessions or weekly phone 
calls, or who request additional help, will receive support from trained peer coaches. 
The goal of this pilot is to evaluate the proof of concept for this hybrid reciprocal peer 
support (RPS) and peer coach intervention to improve heart healthy behaviors among 
Veterans at risk for CVD. The aims are: 
 
Aim 1: Examine the feasibility and acceptability of a 12-week hybrid peer coach-
reciprocal peer support intervention for Veterans at risk for CVD  
• Feasibility will be evaluated by ease of recruitment, measurement of enrollment 
and retention rates 
• Acceptability will be assessed quantitatively by successful and attempted peer 
partner contacts as well as self-report of amount, frequency and modality of 
contacts, rates of participation in group sessions, and through post-intervention 
qualitative interviews with study participants and study staff 
 
Aim 2: Explore gender differences in feasibility/acceptability of new hybrid peer support 
model 
• Gender differences will be evaluated through qualitative comparison of 
participant reported experiences with intervention content as well as peer and 
group interactions by gender; and, quantitatively via exploration of differences in 
enrollment, retention, refusal reasons and frequency of peer contacts 
 
Background and Significance. The majority of middle-aged Veterans have at least 
one risk factor for cardiovascular disease1; these risk factors and subsequent 
cardiovascular disease (CVD) lead to significant personal and financial burden for 
patients and the VA healthcare system2. Poor social support incurs additional risk of 
cardiac and all-cause mortality 3, while higher levels of social support lead to better 
health outcomes4. Unfortunately, many Veterans are socially isolated, and 61.8% of 
female and 47.6% of male middle-aged Veterans are unmarried 5. While supplemental 
social support can come from multiple sources, one type that may be especially well-
suited to the Veteran population is peer support. Peer support is an evidence-based 

 
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approach to augmenting social support and could be a valuable tool to promote Veteran 
engagement in CVD risk reduction behaviors. There are multiple approaches of using 
peer support to improve health. One example is reciprocal peer support which pairs 
individuals to both give and receive social support around a common health goal. A 
second is peer coaching which delivers unidirectional support from someone with 
advanced training and who has improved their health behaviors to an individual with the 
same disease state but who is currently struggling with behavior change. Both peer 
coach and reciprocal peer support models have been effective in promoting health 
outcomes 6,7. The strength and benefit of these different models of peer support varies 
based on patients’ motivation levels and their ability to proactively engage with peers.  
Design. We propose a pilot study that will examine a 12-week intervention to evaluate 
proof of concept of a hybrid peer coach/reciprocal peer support intervention for 
Veterans (Figure 1). Using the ORBIT (Obesity Related Behavioral Intervention Trials) 
framework for intervention development8, this phase II study will aim to assess 
acceptability and feasibility with specific attention to gender-differences and an 
assessment of factors contributing to successful peer engagement. Veterans who are 
at-risk for developing CVD will be invited to participate in a novel peer-support 
intervention that combines reciprocal peer support with additional peer coaching for less 
motivated participants and provides all participants with interactive, facilitated group 
sessions. The study will include up to 24 patients (or up to 12 peer-partner pairs) and up 
to 6 peer coaches per cohort. We will consider conducting a second cohort for this pilot 
depending on the results of the initial cohort. This study was presented to the Durham 
COIN’s Veteran Research Engagement Panel (VetREP), a group of 11 Veterans who 
are dedicated to providing feedback, and input from this panel was incorporated into the 
design, including content for group sessions, peer partner matching criteria, approach to 
recruitment messaging, and intervention name. 
 
Figure 1. Hybrid Reciprocal Peer Support/Peer Coach Intervention 
 

 
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Because participants who will be peer partners and peer coaches will both be 
considered study participants, we will list their eligibility criteria separately. 
 
Peer support partner eligibility criteria will be determined by electronic data 
abstraction:  
Inclusion Criteria 
• Age 35-64 years 
• Enrolled in a Durham VAHS primary care clinic (including the women’s health 
clinic) 
• At risk for CVD as defined by having at least one of the following: 
o Uncontrolled hypertension defined as at least one blood pressure >150/100 
in the previous 12 months 
o Documented history of obesity defined as (BMI >30) in the previous 12 
months 
o Uncontrolled non-insulin dependent diabetes mellitus (E11) defined as a 
hemoglobin A1c >8.0 in the last 12 months 
 
Peer support partner Exclusion Criteria: 
• Insulin-dependent diabetes  
• Serious mental illness defined as schizophrenia, bipolar disorder, dementia, active 
psychosis psychiatric hospitalization within the last 12 months or current high-risk 
suicide flag in their CPRS medical record 
• Active substance use as documented in CPRS or positive screening during 
telephone screening 
• Limited Life expectancy (<6 months) or severely ill defined as enrolled in hospice 
or actively undergoing chemotherapy or radiation therapy for cancer 
• Current pregnancy 
 
Additional Peer support partner eligibility criteria will be determined by telephone 
screening: 
• English as preferred language  
• No significant hearing impairment that precludes participation in telephone calls 
• Lives within 30 minutes of the Durham VAMC 
• Agrees to attend regular visits per study protocol 
• No contraindication to engage in at least moderate physical activity 
• Lack of planned pregnancy within next 6 months 
• Willing to use personal phone for peer and coach contact 
  
Peer coach eligibility criteria will be determined by electronic data abstraction: 
Peer coaches are intended to be patients with at least one CVD risk factor that was 
previously out of control and who have made a sustained behavior change related to 
increasing physical activity or diet. Coaches will be initially recruited through existing 
Durham VAMC program staff (e.g., nutritionists, MOVE! staff) who may be able to 
identify a potential coach based on the following core criteria. We will mail recruitment 
letters to potential coaches identified by staff. If we cannot recruit sufficient number of 

 
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coaches using this method, we will conduct an administrative data pull to identify 
potential coaches. 
 
Core Inclusion Criteria for coaches 
• Age 35-64 years 
• Enrolled in a Durham VAHS primary care clinic (including the women’s health 
clinic) 
• At least one of the following: 
o Hypertension  
o Hyperlipidemia  
o Current or prior obesity demonstrated by current BMI <30 with previous 
BMI >30 within last 24 months 
o Non-insulin dependent diabetes  
• Sustained improvement in physical activity or dietary change within the previous 
3-6 months 
 
Data Pull Inclusion Criteria  
• Age 35-64 years 
• Enrolled in a Durham VAHS primary care clinic (including the women’s health 
clinic) 
• At least one of the following: 
o Hypertension with most recent BP <140/90, but with at least one BP 
>150/100 in prior 24 months 
o Prior obesity demonstrated by current BMI <30 with previous BMI >30 
within last 24 months 
o Non-insulin dependent diabetes with hemoglobin a1c <8.0 with value >8.0 
within the last 24 months 
 
Peer coach exclusion criteria 
• Insulin-dependent diabetes  
• Serious mental illness defined as schizophrenia, bipolar disorder, dementia, active 
psychosis, psychiatric hospitalization within the last 12 months or current high-risk 
suicide flag in their CPRS medical record 
• Active substance use as documented in CPRS or positive screening during 
telephone screening 
• Limited Life expectancy (<6 months) defined as enrolled in hospice 
• Contraindication to engage in at least moderate physical activity 
• Current pregnancy or planned pregnancy in next 6 months 
 
Additional Peer coach eligibility criteria will be determined by telephone 
screening: 
• Sustained improvement in physical activity or dietary change within the previous 3-
6 months 
• English as preferred language  
• No significant hearing impairment that precludes participation in telephone calls 

 
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• Lives within 30 minutes of the Durham VAMC 
• No contraindication to engage in at least moderate physical activity 
• Agrees to attend regular visits per study protocol 
• Lack of planned pregnancy within next 6 months 
• Willing to use personal phone for peer contact 
 
Eligible patients will receive a recruitment letter from study staff at the Durham VAMC. 
Participants will have a least a week after recruitment letters are mailed to call in and 
opt-out of study participation. Potential participants will also be recruited via provider 
referrals or by calling study staff in response to advertisements. Study staff will call 
patients to further ascertain eligibility, describe the study and schedule an in-person 
baseline assessment.  
 
Baseline visit: Veterans meeting eligibility criteria and who express interest in 
participating in the study will be scheduled for an in-person visit with a study staff 
member. Participants will sign a written consent and HIPAA. After completing the 
consent process, participants will complete self-report measures (see Table 1 below). 
This visit will be scheduled at a time acceptable to the Veteran and participants will be 
compensated $50 for this visit. 
 
Table 1. Outcome measurements 
 
Baseline visit content: The Veteran will 
complete surveys and baseline 
measurements including height, weight, 
blood pressure, arm curls, six minute 
walk, fasting blood draw, and an 
assessment to obtain information for peer 
matching (not peer coaches). Patient will 
also receive an activity monitor at the 
baseline visit. Participants will be 
compensated up to $120;$ 50 for 
completion of the baseline visit, $50 for 
the 12-week post-assessment, incentive 
of $20 for completing 10-12 weekly 
phone calls with their peer support, or $10 for completing 4-9 weekly phone calls with 
peer support. This will be measured by self-report through paper logs that participants 
will submit and/or through SMS/text messaging updates. The participants will be 
instructed not to include identifying information in texts.   
 
Reciprocal peer pair matching: Prior peer support research supports the importance of 
giving and receiving peer support from someone of similar background and life 
experience (i.e., health condition). Peer pairs will be matched on primary behavior goal 
(either physical activity or diet) and gender. If possible given the small size of this study, 
peer pairs will also be matched on additional characteristics such as military era. 
However, we suspect that matching on this many variables will prove difficult due to the 
Measure 
 
Baseline 
Week 12 
Primary Outcomes 
Feasibility: Enrollment/Retention rates; amount peer contact 
X 
X 
Acceptability: Qualitative interviews and peer process 
evaluation 
 
X 
Secondary Outcomes 
Patient Activation Measure (PAM) 
X 
X 
International Physical Activity Questionnaire, short form 
X 
X 
Starting the Conversation (Diet) 
X 
X 
Health Specific Social Support instrument 
X 
X 
Self-report heart health support 
X 
X 
Physical parameters (height, weight, blood pressure) 
X 
X 
Physical tests (Six-minute walk test, arm curl test) 
X 
X 
FitBit output 
 
X 
Descriptive measures 
 
 
Demographics including smoking status, medical risk factors 
X 
 
Military sexual trauma (MST) 
X 
 
PSQ 8 
X 
X 
PTSD PC-PTSD-5 
X 
X 
 

 
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small sample size. In the event that we have trouble matching an enrolled participant or 
a participant withdraws from the study, we may consider relaxing our criteria or 
matching more than two peers together, or have a coach work with a single participant 
directly.  
 
Peer coaches: Before interaction with reciprocal peer pairs, coaches will undergo 
approximately 3-5 hours of formal motivational interviewing-based communication 
training by study team members including key skills such as active listening, non-
directive support, eliciting change-talk, promoting incremental change, and patient 
confidentiality 3,11. Peer coaches will reflect on their experience improving their own 
CVD risk factor control and consider how they can work with other Veterans to achieve 
similar success 11. Peer coach training will be reinforced at monthly peer coach “check-
in” meetings for debriefing and problem solving12. Coaches can also contact study team 
members if any urgent issues or concerns arise. Coaches will receive up to $370 in  
incentive payments for participation in study activities: $50 for completing the baseline, 
$75 for the initial training, up to $75 for attending and leading activities at the 3 group 
sessions ($25 per group), $50 for the 12-week follow-up and $10 per month per 
participant coached by phone up to a maximum of $40 per month (120 total). Coach to 
participants calls will be verified by self-report through submitted paper call logs and/or 
SMS/text reporting. They will be paid at 3 time points. 
 
Initial Peer contact:  Participants who complete the baseline assessment will be 
scheduled to attend the first group session (see Table 3). During this session, 
participants will be introduced to both their peer partner and peer coaches. This initial 
session will include an overview of key CVD facts, action planning, a brief (<1 hour) 
training session on being an effective peer partner (e.g. instruction on key MI 
communication skills), and relationship building activities for peer partners. Participants 
will set an initial action plan step towards their behavioral goal. At the end of this 
session, peer pairs will agree upon a time for their next contact which will take place via 
telephone. Depending on the timing of recruitment and the first group session, peer 
coaches may reach out to individual reciprocal peer participants by phone while 
awaiting the first group session to keep them engaged. 
 
Structured group sessions: As noted through prior work, peer support interventions are 
most successful when paired with a structured behavior change or self-management 

 
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program. Behavioral change techniques 13,14 to be deployed through group sessions 
and peer interactions are noted in Table 2. Over the three-month pilot study period, 
there will be three group sessions led by peer coaches and a study interventionist at 
approximately week 1, week 3 and week 5. Each session will include brief instruction 
and practice of an accessible physical activity (i.e. stretching, yoga), a small amount of 
didactic content, and 
time for peer partners 
to problem solve 
action plans and 
provide in-person 
encouragement and 
support.  Physical 
activity exercises and 
didactic content will be 
led by a study 
interventionist; peer 
activities will be led by 
coaches. Participants 
will be asked to 
complete brief 
assessments of the 
quantity and quality of 
their interactions with 
peer partners since the previous group session. Content for listed domains will be 
adapted from existing and previously developed resources (e.g. MOVE!’s Telephone 
lifestyle coaching workbook). Participants will be provided with personalized 
participation certificates at group 3. 
 
Reciprocal Peer Pair contacts: Peer partners will be encouraged to have at least one 
contact every week for 12 weeks; this frequency of calls is supported by previous work 
in peer support and will allow them to work together on their weekly action steps 7,15. 
Peer partners may have more frequent contact if they choose. Based on prior studies, 
we anticipate that the average length of each call will be approximately 10-20 minutes. 
In addition, peer partners will be encouraged to send text messages to each other or the 
coaches. We will recruit patients who are willing to use their own personal phone for 
peer and coach contact. During weekly calls, peer partners will discuss progress on 
their action plans and support each other with problem solving. Peer coaches will reach 
out to each peer partner after week 1 to check in about how the first call went and offer 
suggestions and assist with problem solving if communication concerns are raised. Peer 
buddies will be asked to send an SMS/text message to the study team phone after each 
call with their partner to assist with verification that a call has taken place. If no message 
has been received for a buddy pair for one week, then a SMS/text message will be sent 
to the pair reminding them to attempt a call. If no message has been received from a 
buddy pair for two weeks, then a peer coach will call them individually to check-in and 
assist with any problem solving as needed. 
 

 
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Partners will be provided with sample questions and prompts to initiate and guide 
discussion on action plans and problem solving. However, they will not be scripted as to 
promote authentic communication and enhance the perceived value of peer 
communication; thus, tangential topics or patient concerns may be covered. All 
participants will be instructed not to give medical advice and that they should not act on 
any advice given to stop or start a new therapy without discussing with their provider. 
Participants will have contact information for study staff in case a participant would like 
to request a new partner and the 24-hour VA crisis line number if he or she is having 
urgent concerns about a partner’s well-being. It is expected that incompatibility of peer 
dyads requiring cessation of peer contact will be rare based on previous reciprocal peer 
support trials 6,16. If a peer pair is recognized as incompatible, those peers will be 
accommodated on a case-by-case basis including potentially having them join another 
peer partner team or being supported directly by a peer coach. 
 
Peer coach contacts: Peer coaches will have up to three types of interactions with the 
reciprocal peer pairs: 1) leading activities and discussions at group sessions, 2) a 
beginning and mid-study phone call to individual peer partners to check-in on peer 
partner experiences and provide guidance and interaction support, and 3) ongoing 
phone support as needed. As needed coach phone support will be triggered by: 1) lack 
of participant engagement in calls to partner or attending group sessions (for example, if 
there are no phone calls between a pair of reciprocal peer support partners in first 10-14 
days), or 2) if requested. Coaches will have sample scripts to reference during phone 
support calls and a manualized guide for group session activities. All group sessions will 
be monitored for fidelity by the PI using a checklist for key features of the planned 
session. Coaches will then receive supportive feedback on their approach and pointers 
on needed adjustments. They will also have opportunity to role play during at least 
group monthly sessions with all peer coaches to practice and hone their communication 
and non-directive support skills. The amount of time each coach will spend providing 
support will be 10 hours over 12 weeks at a minimum for group session participation 
and initial calls with peer pairs. Additional time with ad hoc support for individuals as 
needed is unknown and will be determined during the course of the pilot, but is 
expected not exceed an additional 12 hours. Peer coaches will be asked to keep a log 
of the time spent working with peers during the course of the study. 
 
Peer contact monitoring: We will ask participants to send an SMS/text message to the 
study coordinators study phone after each call with their peer buddy (and for coaches 
after calls with a peer buddy participant). If we have not heard from a buddy pair after 
one week, we will send SMS reminder. All text messages will be sent from a study 
specific phone number used only for texting and calling participants.  Receiving 
SMS/text message verification of buddy pair communication and coach to buddy 
communication will help us to identify an efficient, validated method of communication 
verification for future use in future studies. Other monitoring approaches may include: a) 
self-report of the number and approximate length of recent calls during each group 
session; b) a brief, post-intervention survey that will include specific questions about 
frequency and duration of peer communication; c) informal participant feedback about 
peer contact process, improvements needed to peer orientation and need for specific 

 
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support materials. Participants will receive the portion of their incentive that is based on 
the number of calls completed depending on the number of calls that they have 
reported. 
 
Outcome Measures: Outcome measures will be assessed during a post-intervention 
visit at 12 weeks with all peer coaches and reciprocal peer partners. Participants who 
complete the post-intervention evaluation at week 12 will receive a $50 incentive. Heart 
health buddies are paid $50 after the baseline and after the 12-week follow-up visit.  
 
Feasibility will be evaluated by assessing recruitment rates overall and by different 
approaches (i.e., #patients sent letters, #consented, #consented in response to flyers, 
#consented by provider referral), retention rates (#participants completing week 12 
post-intervention assessment, # completing baseline assessment), drop-out rates, and 
reasons for refusal. We will also track frequency and amount of completed peer partner 
and peer coach calls using self-report via SMS/text message and on paper logs as well 
as attendance at group sessions.  
 
Acceptability will be assessed through post-intervention interviews. The conversation 
will be recorded via a VA-approved device (USB Sparky recorder). Peer partners will be 
called on the phone. Coach feedback will be collected at either the final coach check-in 
group, or over the phone.  The recording will be kept on a VA computer behind a VA 
firewall. For all participants, we will ask about perceived value of group sessions, 
training experience, facilitators and barriers to peer interactions, and general feedback 
about improving the intervention. Reciprocal peer participants will also be questioned 
about their perceptions of the peer matching process and receipt of support from peer 
coaches. Peer coaches will be asked about the value of the monthly coach meetings 
and their experience supporting reciprocal peer pairs and individual participants. 
Experience with peer interaction will be assessed using an established 17-item peer 
process measure17 that includes questions on availability of peer, assistance in daily 
management, support provided and linkage to care, and a measure that assesses to 
what extent support received was directive vs non-directive18. Social support will be 
evaluated by Health specific social support scale, which is a 12-item scale used in other 
interventional research. Physical activity will be measured using the International 
Physical Activity Questionnaire, short form20 which assesses PA during the previous 7 
days and is summarized in a continuous measure of MET-min per week. It will also be 
assessed at baseline and 12 weeks with a 6-minute walk and arm curl test, and 
recording steps and active minutes from an activity monitor at group sessions and the 
12 week study visit.  Diet will be assessed using Starting the Conversation21 which is an 
8-item measure designed for health behavior promotion with summary scores ranging 
from 0 (more healthy diet) to 16 (less healthy diet). Physical parameters such as weight, 
height, serum lipids and blood pressure will also be measured. Venipuncture will take 
place at a Durham VAMC clinical lab to obtain lab values, with blood samples staying 
within the Durham VAMC environment. Specimens will not be retained.  
Analyses: Aim 1: Examine the feasibility and acceptability of a 12-week hybrid peer 
coach/reciprocal PS intervention for Veterans at risk for CVD:  

 
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Quantitative measures We will calculate the outcome retention rate. For self-report we 
will calculate mean and distribution of the number and duration of peer phone contacts 
(both reciprocal peer pairs and peer coach calls) and compare to planned call 
frequency. We will also ask participants about any behavior changes made during the 
intervention and compare change from baseline in a diet and exercise assessment. We 
will also examine changes from baseline in patient-centered measures (e.g. physical 
parameters, social support) to assess variability of outcome measures to ensure 
appropriate responsiveness needed for use in an IIR. We will not interpret p values or 
determine an effect size as this is not appropriate for a pilot22.  
Qualitative measures: Post-intervention interviews will be audio-recorded  and 
analyzed using a rapid analysis approach based on key features of peer support 23 (e.g. 
support of daily management) and data-derived codes. Participant responses will be 
organized by pre-planned constructs (e.g., barriers and facilitators to peer partner 
interactions) and suggestions for improving the intervention. The qualitative interview 
will take place by calling the participant from a VA phone or in-person focus group for 
the coaches, and recorded on a VA-approved recording device (Sparky USB recorder). 
The recordings will be kept on a VA computer behind the VA firewall. Team members 
will listen to the recorded interviews and take detailed notes according to the pre-
planned constructs. This process will be completed for approximately five interview 
recordings. After the initial review and coding, the preliminary findings will be discussed 
as a team. Additional review by other team members will take place as needed. Once 
any differences have been resolved, then the rest will be coded independently by Dr. 
Goldstein. Interview results will inform further intervention tailoring. For example, we 
may learn that peers would prefer more frequent opportunity to meet with their partner 
early in the intervention or that peers want additional access to peer coaches.  
Aim 2: Assess gender differences in feasibility and acceptability of 12-week hybrid peer 
coach/reciprocal peer support intervention: We plan to target 50% recruitment of women 
Veterans to allow for stratification of feasibility and acceptability assessments by 
gender. We will seek evidence of large differences in recruitment, retention, or rates of 
peer call completion that might suggest lower engagement in intervention activities. 
Additionally, we will stratify interview analysis by gender to explore qualitative findings 
that may vary by gender. Such differences, if identified, would inform the need for 
gender-specific tailoring of the intervention activities. For example, if female participants 
attend group sessions at notably lower rates than male participants and qualitative 
interviews identify that women do not feel comfortable participating in peer activities with 
men, then we will consider a gender-specific peer intervention for CVD risk reduction in 
the future.  
 
Sample size: As noted, we plan to recruit sufficient participants to support two cohorts 
of reciprocal peer pairs and group sessions, with a target enrollment of up to 24 
Veterans plus up to 6 Veteran peer coaches. This will allow adequate opportunity to 
evaluate feasibility and acceptability for our pilot protocol and sufficient input from 
participants to inform intervention tailoring and improvement for a larger RCT while 
being responsive with the practical limitations of the shortened time period for this pilot.  
A larger sample is not needed as we are trying to be powered to perform inferential 
statistics. 

 
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Data Management: Data collection will occur using VA-approved software, which are  
REDCap, Epi Info,and/or Excel, and Atlas Ti. Recording of the post-intervention 
interview will be over the phone and recorded on a Sparky device. A study tracking 
database will be created for this study in conjunction with the Center’s software 
development team using Microsoft.NET and/or excel spreadsheets. Outcome measures 
will be entered into database using REDcap,  which is a VA Intranet Web application 
approved by VA and run by VA VIReC. The REDcap software is web-based but 
participants will be interviewed either in person or over the phone and data will be 
entered by study staff on VA computers behind the VA’s firewall. The data are housed 
on a VA Informatics & Computing Infrastructure (VINCI) Server. All study data will be 
stored on a secure VA server.  The tracking and survey databases for this study will be 
developed in conjunction the Durham COIN biostatistics unit (directed by Dr. Olsen, 
mentor) and the software development core. Call attempts, call lengths and number of 
texts will be collected by self-report. Study participants will be encouraged to wear a 
pedometer/activity meter for the duration of the study. We will provide a non blue-tooth 
enabled pedometer/activity meter type device to the participants. We will ask them to 
bring their pedometer to each group meeting, and the final assessment, so that steps or 
daily activity data from the past 21-30 days can be manually collected from the device 
by a staff member during the group meeting/assessment.    
 
Safety Monitoring Plan. This is a minimal risk study so the potential for serious 
adverse events related to the study is low. We will document reported adverse events or 
problems on a standardized case report form detailing the event, when it occurred, any 
pertinent diagnostic workup, any treatment, and whether and when the symptom or 
problem resolved. Study staff will report any adverse event or unanticipated problem to 
the PI immediately. We will review any such events and determine the likelihood they 
were due to the study. Statistical tests are not planned for analyzing the safety data 
during the conduct of the study. There are no conditions that trigger an immediate 
suspension of the research. The PI will report any serious, unexpected, and study-
related adverse event or unanticipated problem to the local IRB according to the 
institution’s requirements. The IRB will review all adverse events during continuing 
review, which will likely occur annually. All adverse events will be reported in the annual 
report to the VAMC IRB.   
There are few potential risks associated with any of the measures or data to be 
collected. Participants do not have to answer any question that they do not wish to 
answer, as will be explained during the consent process. There are also small risks of 
injury or heart problems due to increased participation in physical activity. The threat of 
this potential problem will be reduced by screening for contraindications to physical 
activity participation and by providing proper instruction regarding methods for engaging 
in physical activity safely, as well as contraindications for continuing physical activity. 
Because the main physical activity to be stressed is low impact (e.g. yoga, walking), we 
do not anticipate that the health risks will be over and above the risks normally 
associated with daily activities. 
 
Privacy, Confidentiality, and Information Security 

 
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1. Lists of Data Reviewed and/or Collected for Screening/Recruitment and 
Conduction of Study:  
 
The Personal Health Information that will be obtained, used, and/or shared for this study 
includes:   
Identifier(s) 
Source(s) of Health Information 
 Names 
 Medical history & physical exam 
information 
 All geographic subdivisions smaller than 
a State, including street address, city, 
county, precinct, and zip code.  Describe: 
address 
 Photographs, videotapes, 
audiotapes, or digital or other images 
 All elements of dates (except year) for 
dates directly related to an individual, 
including birth date, admission date, 
discharge date, visit or treatment dates, 
etc.; and all ages over 89,  Describe: 
birthdate, treatment dates 
 Biologic specimens (e.g., blood, 
tissue, urine, saliva). Describe: blood 
draw to measure hemoglobin A1c and 
Fasting lipid levels 
 Telephone numbers 
 Progress notes 
 Fax numbers 
 Diagnostic / Laboratory test results 
 Electronic mail addresses 
 Operative reports 
 Social Security Numbers 
 Imaging (x-ray, CT, MRI, etc.) 
 Medical record numbers 
 Discharge summaries 
 Health plan beneficiary numbers 
 Survey / Questionnaire responses 
 Account numbers 
 Billing records 
 Certificate and/or license numbers  
 HIV testing or infection records 
 Vehicle identifiers and serial numbers, 
including license plate numbers  
 Sickle cell anemia information 
 Device identifiers and serial numbers 
 Alcoholism or alcohol use 
information 
 Web Universal Resource Locators 
(URLs) 
 Drug abuse information 
 Internet Protocol (IP) address numbers 
 Mental health (not psychotherapy) 
notes 
 Biometric identifiers, including finger & 
voice prints 
 Psychological test results 
 Full-face photographic images and any 
comparable images 
 Genetic testing 
 Any other unique identifying number, 
linked study ID, characteristic, or code, 
describe:  Study ID 
 Other, describe:        
 
2. Data and/or Specimen Acquisition:   
Data for this study will be collected through (check all that apply): 
  Prospective data and/or specimen collection obtained from participants.  Provide 
description of processes:  Surveys, in-person sessions and telephone interviews. 

 
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  Retrospective data collection and/or specimens obtained from medical chart 
review/data access.  Describe how data will be obtained (e.g., fileman, CDW, etc.):  We 
will review medical chart data to check if participants meet inclusion criteria. We will also 
perform a data pull of potentially eligible participants using VINCI, using approved VA 
procedures. Potentially eligible participant data will be pulled and transferred to a secure 
Durham VAMC server.  As the potential study pool may be large but the study number 
is small, the data pull will pull small batches of names and IDs to review and screen, 
before additional names are pulled until enrollment is complete.  
  Retrospective data collection and/or specimens obtained from an IRB-approved 
data and/or specimen repository.  Indicate the repository source including name, VA 
location, and IRB number:       . 
Note:  for data and/or specimens obtained from a VA approved data repository, a Data 
Use Agreement (DUA) must be executed prior to obtaining data and/or specimens.  See 
VHA Handbook 1200.12 for further information. 
 
3. Level of Data:   
The following level(s) of data will be acquired/maintained for this study (check all that 
apply): 
  Identified (e.g., names, addresses or other identifiers included)  
  Coded (direct and/or all identifiers removed, but study code/ID included)  
  De-Identified (all HIPAA 18 and study ID/code removed): 
  Verified Statistically  
 
OR 
  Verified by Absence or Removal of HIPAA 18 and study ID  
  Limited Data Set 
  Other: Describe:        
 
4. Location of Data and/or Specimens, and Data Retention Plan:   
A. Data will be stored electronically in \\vhadurhsrdfile1\$projects. If a tracking database 
is developed for the study, at \\vhadurhsrdfile1\$research\Distributed 
Apps\HSRDTrackingApp.  Data that will be stored electronically include patient 
demographics, survey data and data from in-person sessions. The data will be stored 
on a secure VAserver (Durham VAMC building 1, room FG104) and backed up on a 
regular schedule.  
  Data will also be placed at the VA Informatics and Computing Interface (VINCI; 
http://vaww.vinci.med.va.gov/vincicentral/VINCIWorkspace.aspx). The VA Informatics 
and Computing Infrastructure is a partnership between the VA Office of Information 
Technology and the Veterans’ Health Administration Office of Research and 
Development.  Researchers and operations staff can use VINCI to access data and 
statistical analysis tools in a virtual working environment through a certified VHA 
network computer using the VA Intranet or Virtual Private Network (VPN).  
B. Data Retention Plan 
 Research records will be maintained and destroyed according to the National 
Archives and Records Administration, Records Schedule Number:  DAA-0015-2015-
0004.  Records destruction, when authorized, will be accomplished using the then 
current requirements for the secure disposal of paper and electronic records.  Currently, 

 
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destruction of research records (see DAA-0015-2015-0004, section 7.6 “Research 
Investigator Files” for materials included in research records) is scheduled for 6 years 
after the cut-off (the cut-off is the completion of the research project) and may be 
retained longer if required by other federal agencies.  Records will not be destroyed 
without pre-notification to the facility records manager.   
  Other data retention plan, describe:        
 
5. Data Access and Data Recipients:  Only members of our VAMC research team 
will have access to identifiers and coded data.  Study staff at other VA sites will 
access the data stored on a Durham VA server through a link provided to them. 
They will have access to a study folder that is behind the VA firewall.  
 
All VA research personnel who have access to VHA records are instructed, in 
accordance with VA policy, on the requirements of Federal privacy and information laws 
and regulations, VA regulations and policies, and VHA policy. All study personnel who 
are VA employees working within the VA system have fulfilled all required HIPAA and 
other VA security and privacy policy training requirements and have agreed to follow 
guidelines pertaining to the protection of patient data. All research staff sign VA Rules of 
Behavior, and all study staff are up-to-date with VHA Privacy Policy Training and the VA 
Office of Cyber and Information Security Awareness Training Course. The data security 
and privacy procedures summarized in that course include logging off or locking the 
computer when walking away from it; no sharing of access codes, verify codes or 
passwords; not allowing anyone else to use the computer under one’s password; and 
disposing of sensitive information using VA-approved methods (e.g., shredder bins). 
Access to study data will be removed for all study personnel when they are no longer 
part of the research team. A partial off-site waiver has been obtained to conduct study 
group meetings at an off-site location (Duke Sara W. Stedman Nutrition and Metabolism 
Center). No data will be stored there. A limited amount of phi (sign in sheets, retrieval of 
participants’ paper call logs or self-questionnaires) will be transported to and from this 
site. Study staff will secure the data by placing in secure containers during transport.   
 
6. Data and/or Specimen Transportation and/or Transmission for all data and/or 
specimens involved in the study:   
 
I. 
  Data and/or specimens will not be transported or transmitted outside of 
Durham VAMC environment. 
II. 
  Data and/or specimens will be transported BETWEEN sites that are under 
the auspices of the Durham VA Medical Center.   
III. 
 
a. 
 Local DVAMC memorandum “Authorization to Use, Process, Store, or 
Transmit VA Sensitive Information Outside VA Owned or Managed Facilities” 
has been pre-filled out for each study team member who may transport the 
data and/or specimens off-site.  This (these) forms are included with the IRB 
materials.   
 

 
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b. 
  Containers (e.g., briefcase, bin) are labeled with the following notice (label 
placed on the outside of container) in accordance with VHA Directive 6609: 
NOTICE!!! Access to these records is limited to: AUTHORIZED PERSONS ONLY. 
Information may not be disclosed from this file unless permitted by all applicable legal 
authorities, which may include the Privacy Act; 38 U.S.C. §§ 5701, 5705, 7332; the 
Health Insurance Portability and Accountability Act; and regulations implementing those 
provisions, at 38 C.F.R. §§ 1.460 – 1.599 and 45 C.F.R. Parts 160 and 164. Anyone 
who discloses information in violation of the above provisions may subject to civil and 
criminal penalties. 
 
   Data and/or specimens will be transmitted to other VA sites using the 
following method(s):  
  Data are de-identified and thus will be sent via unencrypted e-mail or 
unencrypted disk (encryption is optional). 
  Data are coded or contain identifiers and thus will be sent  
  Other, describe:   
B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier 
(tracking is optional). 
  Specimens are coded or contain identifiers and thus will be sent via VA-
authorized carrier with tracking.   
  Other, describe:   
 
IV. 
     
  Data and/or specimens will be transported to non-VA/VHA sites (e.g.,       
academic affiliates, laboratories, etc.) using the following method(s): 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or 
unencrypted CD. 
  Data are coded or contain identifiers and thus will be sent via <chose 
method of transfer such as FIPS 140-2 encrypted CD or FIPS 140-2 
encrypted hard drive/flash drive> using VA—approved carrier with tracking.   
  Data are coded or identified and will be sent via the Safe Access File 
Exchange (SAFE) at https://safe.amrdec.army.mil/safe/.  SAFE is a secure 
method of exchanging files <2GB to and from individuals with a valid .gov, 
.mil, .com, or .edu email address. <insert information including collaborator 
name.> 
  Data are coded or identified and will be uploaded to sponsor website 
using electronic case report form (eCRF) <insert information including 
sponsor name and URL and the encryption the site uses.> 
 Other, describe: paper sign in forms as well as collection of phone logs will 
be physically secured and transported by study staff. 
B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier 
(tracking is optional) or will be hand-delivered by research study personnel.  
Specify method of delivery:        

 
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  Specimens are coded and thus will be sent via VA-approved carrier with 
tracking or will be hand-delivered by research study personnel.  Specify 
method of delivery:        
V. 
  We will communicate with veterans enrolled as participants in this research 
study through MyHealtheVet .    
 
 
In accordance with the HIPAA and the Privacy Act, for any coded or identifiable data or 
specimens released from the Durham VAMC (with the exception of Limited Data Sets), 
an Accounting of Disclosure (AOD) will be maintained (e.g., in a database or 
spreadsheet) that includes the participant’s name, date of the disclosure, description of 
the nature of the Individually Identifiable Information (III) disclosed, purpose of each 
disclosure, and the name and address of the person/agency to whom the disclosure 
was made. 
C.      
 Local DVAMC memorandum “Authorization to Use, Process, Store, or 
Transmit VA Sensitive Information Outside VA Owned or Managed Facilities” has 
been pre-filled out for each study team member who may transport the data 
and/or specimens off-site.  This (these) forms are included with the IRB 
materials.  <Please contact the facility privacy or security officer to obtain a copy 
of the form.> 
The memo referenced above is required to be fully signed for each study team 
member BEFORE any data can be transported by that individual. 
 
D. 
  Containers (e.g., briefcase, bin) are labeled with the following notice (label 
placed on the outside of container) in accordance with VHA Directive 6609: 
NOTICE!!! 
Access to these records is limited to: AUTHORIZED PERSONS ONLY. 
Information may not be disclosed from this file unless permitted by all applicable 
legal authorities, which may include the Privacy Act; 38 U.S.C. §§ 5701, 5705, 
7332; the Health Insurance Portability and Accountability Act; and regulations 
implementing those provisions, at 38 C.F.R. §§ 1.460 – 1.599 and 45 C.F.R. 
Parts 160 and 164. Anyone who discloses information in violation of the above 
provisions may subject to civil and criminal penalties. 
 
 
7. Risk Mitigation Strategies:   
  Data are fully de-identified (stripped of HIPAA 18 and study ID/code) before being 
shared outside of Durham VAMC. 
  Specimens are fully de-identified (stripped of HIPAA 18 and study ID/code before 
being shared outside of Durham VAMC. 
  Direct identifiers will be maintained separately from data and or specimens by using 
a code to “identify” subjects.  In a separate database (i.e., a “linking” or “cross-walk” 
database) this code will be linked to identifying subject information.   
  Other, specify:        
 
8. Suspected Loss of VA Information: 

 
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Should any incident such as theft or loss of data, unauthorized access of sensitive data 
or non-compliance with security controls occur it will be immediately reported according 
to VA policy. All incidents regarding information security/privacy incidents will be 
reported to the ISO and PO within 1 hour of acknowledgement of issue and done so 
using the VHADUR Research Events Report e-mail group 
(VHADURResearchEventReport@va.gov). 
 
9. Reporting of Results:   
  Reporting of results, such as in scientific papers and presentations, will never 
identify individual subjects.  Data will be presented in aggregate and individual-level 
data will not be published. Research results will be conveyed to the subject and and/or 
health care provider by request.  
  Other results reporting plan, describe:       
 
10. Future Use of Data: 
 
  Data will be retained for future use.  This is described elsewhere in the protocol and 
is noted in the HIPAA authorization. 
 
  Future Use of data is optional (i.e., not required by the research subject). 
  Future Use of data is required for participation in the study. 
  No future use of data is currently planned. 
 
11. Use of Mail Merge Technology 
  Mail merge programs will be used to generate letters and/or address labels for 
mailings to potential or already enrolled research subjects.  The study team is aware 
that to reduce risk of mail merge related privacy incidents, use of mail merge programs 
requires a 25% accuracy check to verify that (potential) research subject name and 
mailing address are properly “matched”.  If discrepancies are found, a 100% accuracy 
check is required before letters may be mailed.   
 
12. Use of Non-Standard Software 
 I do NOT intend to use any new specialized software (i.e. Software that’s not already 
approved OR installed) in this study. 
 
 I intend to use specialized software that has not already been installed and it has 
been approved for use by the VA Technical Reference Model (TRM) Group.  
(Note: All new software must be approved by TRM before it can be installed on VA 
systems.) 
 
 I intend to use previously installed software on my VA computer.  
 
<Provide the name of the software and a description of how it will be used.> 
 
13. Use of Cloud Computing Services 
 Cloud computing services will NOT be used in this study. 
 

 
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 Cloud computing services WILL be used in this study as described below and have 
been approved nationally by the VA Chief Information Officer (CIO).  (Note: ONLY cloud 
computing services that have been approved nationally may be used.) 
 
 
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