Stroke Self-Management: Effect on Function and Stroke Quality of Life
Phase: NA
Conditions: Stroke
Sponsor: VA Office of Research and Development

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Stroke Self-Management:  Effect on Function and Stroke 
Specific Quality of Life 
 
 
Teresa Damush, PhD, Principal Investigator 
Implementation Research Coordinator, VA Stroke QUERI, 
Associate Professor, IU School of Medicine 
Richard L. Roudebush VAMC 
1481 W. 10th Street (11H) 
Indianapolis, IN 46202 
(317)-988-4277 
teresa.damush@va.gov 
 
Laura Myers, PhD, Co-Investigator 
Research Scientist 
Richard L. Roudebush VAMC 
(317) 988-3482 
laura.myers2@va.gov 
 
Arlene Schmid, PhD, OTR, Co-Investigator 
Assistant Professor, IU School of Health and Rehabilitation 
Research Scientist 
Richard L. Roudebush VAMC 
(317) 988-3480 
arlene.schmid@va.gov 
 
Linda S. Williams, MD, Co-Investigator 
Research Coordinator, VA Stroke QUERI, 
Associate Professor, IU School of Medicine 
Richard L. Roudebush VAMC 
(317) 988-3337 
linda.williams6@va.gov 
 
James D. Fleck, MD, Site-Investigator 
Methodist Hospital 
IU Health Physicians Neurology 
355 West 16th Street 
317-962-5819 
jdfleck@iupui.edu 
 
 
 
 

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Jason Mackey, MD, Co-Site Investigator 
Methodist 
IU Health Physicians Neurology 
355 West 16th Street 
317-962-5819 
jsmackey@iupui.edu 
 
Cristina S. Ivan, MD, Site-Investigator 
Wishard Hospital 
IU Health Physicians Neurology 
1050 Wishard Boulevard RG 6th Floor 
317-630-6146 
crivan@iupui.edu 
 
Zhangsheng Yu, PhD, Co-Investigator 
Biostatistician 
IU School of Medicine Department of Biostatistics 
317-274-2688 
yuz@iupui.edu 
 
Laurie Plue, MA, Co-Investigator 
Co-Implementation Research Coordinator, VA Stroke QUERI 
Richard L. Roudebush VAMC 
(317) 988-2351 
laura.plue@va.gov 
 
Flossy Lincoln, MPH, Project Manager 
 VA Stroke QUERI 
Richard L. Roudebush VAMC 
(317) 988-4892 
flossy.lincoln@va.gov 
 
Gloria Nicholas, BSN/RN, Case Manager 
Clinical Research Nurse I.U. School of Medicine 
Richard L. Roudebush VAMC 
(317) 988-4388 
gloria.nicholas@va.gov 
 
Kathy Snow, MBA w/MIS, Senior Data Manager 
CIEBP 
Richard L. Roudebush VAMC 
(317) 988-2151 
kathryn.snow@va.gov 
 
 
 
 
 

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Jeffery L. Barnd, MCAD, MCSD, Data Manager 
CIEBP 
Richard L. Roudebush VAMC 
(317) 988-3642 
jeffery.barnd@va.gov 
 
Xia He 
Data Manager  
Regenstrief Institute 
317-423-5662 
xhe@regenstrief.org 
 
Evgenia Teal 
Data Manager 
 Regenstrief Institute 
eteal@regenstrief.org 
 
 
Jeff Fahner, RN,  
Clinical Applications Coordinator, Systems Redesign 
Richard L. Roudebush VAMC 
(317) 988-3332 
jeff.fahner@va.gov 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 Follow-up and Record Retention 
 
 

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 1.0 Background 
 
 Epidemiology of Stroke. Stroke is a high volume medical condition. On 
average, one United States citizen experiences a stroke every 45 seconds. 
Stroke affects 700,000 persons each year in the U.S of which 200,000 are 
recurrent episodes.  Stroke is the third leading cause of death, produces the 
greatest number of hospitalizations for neurological disease and is the leading 
cause of adult acute-onset and long-term disability in the United States. Up to 
50% of stroke survivors have some functional disability within 6 months of an 
ischemic stroke event. Veterans surviving stroke are even more vulnerable to 
functional disability given the recent reductions in rehabilitation facilities and the 
fragmentation of acute stroke care services. Stroke is estimated to affect at least 
15,000 veterans each year with estimated costs of $111 million for acute 
inpatient care, $75 million for post acute inpatient care, and $88 million for follow-
up care over 6 months post stroke. 
 
Within the VA, approximately 60,000 patients had a primary outpatient encounter 
for stroke during fiscal year 2010 (FY10). Data from the Office of Quality and 
Performance (OQP) Stroke Special Study demonstrate that more than 5,000 
veterans were admitted to a VA facility for acute ischemic stroke in FY07 and 
another 5000 veterans with a transient ischemic attack (TIA) or mini-stroke, were 
admitted in a VA facility or received care at an urgent clinic or emergency 
department in VA. One year post-stroke mortality for VA inpatients is 
approximately 20%; and 30% of veterans with stroke are discharged to non-
community, institutional settings. The total VA cost of stroke treatment was 
almost $315 million in FY05, with a cost per patient of over $18,000.  
Moreover, patients who have had a stroke or a transient ischemic attack (TIA) 
are at risk for recurrent stroke and death. Over 12% of those with stroke or TIA 
will experience another stroke within a year. A recent study of Canadian TIA 
survivors reported a 22% rate of recurrent vascular events. Although some stroke 
risk factors are not modifiable (e.g. age), many stroke risk factors are modifiable 
(e.g., hypertension, and physical inactivity). Modifiable risk factors are most 
effectively managed through a combination of lifestyle and medication 
management and thus require strategies that target and support behavioral 
modification and the uptake of prescribed therapies by clinical providers.  
 Stroke Prevention Efforts. Although many stroke risk factors are modifiable, 
most patients with stroke or TIA do not have adequate control of their stroke risk 
factors. Data from the National Behavioral Risk Factor Survey indicated only 3% 
of adults living in the US reported healthy lifestyle characteristics (e.g., 
nonsmoking; healthy weight; regular physical activity; and consumption of five 
fruits and vegetables per day). In a recent randomized trial of high-dose folate 
vitamin therapy in patients with recent stroke, stroke survivors in the trial 
continued lifestyle practices that elevated their stroke risk (e.g., cigarette 
smoking). Many studies have documented inadequate control of blood pressure 
after vascular events.  Despite knowledge of the methods and impact of risk 
reduction, providers may not aggressively counsel or treat patients with 
behavioral or medical interventions for stroke prevention.  

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Current VA Secondary Stroke Programs.  With the exception of the Bay Pines 
VAMC in Florida, we are aware of no systematic or standardized programs or 
support available in VHA to improve guideline adherence for stroke risk factor 
management.  Although some programs exist to support specific risk factor 
management (e.g. diabetes, or hypertension), these are not routinely targeted to 
veterans with recent stroke or TIA. Further, there is less support for management 
of behavioral risk factors and for improving stroke survivors’ education and self-
management practices. Yet, educating stroke survivors on stroke risk 
management is mandated by the VA/DoD stroke rehabilitation guidelines, 
championed by the American Stroke Association, and included in the JC criteria 
for stroke care. We have chosen to implement this program within a year of the 
stroke/TIA event given our previous experience in our pilot study. This time 
period provides a sufficient timeframe to harness a patient’s motivation to change 
after stroke. In addition, our preliminary data from stroke survivors suggest that 
stroke survivors are ready to make lifestyle changes after their stroke 
hospitalization and have transitioned to home (see section C). 
 Evidence-based Tools to Manage Stroke Risk Factors. Research of existing 
stroke risk factor management tools revealed two systematic programs: the 
American Stroke Association (ASA) (a division of the American Heart 
Association, AHA) Get with the Guidelines (GWTG) Program and the Stroke 
PROTECT (Preventing Recurrence of Thromboembolic Events through 
Coordinated Treatment) program. Both programs are based upon the AHRQ, 
clinical guidelines for stroke, as are the VA/DoD guidelines for stroke 
rehabilitation.  During acute care for stroke, one of the recommended goals is to 
begin therapies for prevention of recurrent stroke.   
American Stroke Association (ASA). The Get With the Guidelines Program 
(GWTG) is a hospital-based quality improvement program developed to improve 
care for patients with cardiac disease and stroke and to obtain a 20% reduction 
in heart disease, stroke, and risk by 2020. The GWTG Stroke program focuses 
on implementing guidelines for acute stroke treatment and ischemic stroke 
prevention. The program identifies local champions to lead the hospital’s team to 
implement the guidelines prior to patient discharge as research has shown that 
patients are more likely to comply with medication prescriptions at 6 months if 
medications are started during hospitalization.  For ischemic stroke prevention, 
providers target smoking cessation counseling, lipid and cholesterol levels, anti-
thrombotics, weight and exercise management, atrial fibrillation, and diabetes 
management. The stroke module has been rolled out to over 1392 hospitals 
since 2003 and the Bay Pines VAMC is the only VA hospital included in part 
because of the external data reporting requirements.  No data has been released 
to date specifically on secondary stroke risk factor management. 
Most recently, the Scientific Council for the AHA published a set of clinical 
guidelines that promoted physical activity participation among stroke survivors to 
enhance functional status and minimize disability.  Although these guidelines and 
the complimentary physical activity monitoring tools are available from the ASA, 
there is no specific effort to provide them to veterans with recent stroke or TIA. 

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We have incorporated the ASA risk factor management support materials into 
our stroke self-management program. 
 Patient Self-Management programs. During the past several decades, patient-
self management (PSM) programs have been developed to foster self care 
among patients with chronic disease.  Variation exists in terms of the program 
components, location of the program with the health care system and staff 
involvement.  Experts define PSM as strategies that enable the patient’s ability to 
monitor and manage daily health and symptoms, to problem-solve to overcome 
barriers encountered, to modify lifestyle risk factors, and to communicate with 
clinical providers as active collaborators in defining and adhering to health and 
therapeutic goals. 
 
The evidence on the effectiveness of (PSM) programs varies across chronic 
conditions. Randomized controlled trials of PSM programs have demonstrated 
improvements in outcomes for chronic medical conditions including asthma; low 
back pain; hypertension; arthritis; and diabetes. In addition, PSM programs offer 
patients options and strategies for coping with chronic medical conditions in order 
to function daily and maintain health-related quality of life. Patients with chronic 
disease are often left on their own to cope and manage their symptoms in 
between medical visits.  
In summary, although a couple of hospital based quality improvement programs 
exists, there are no evidence based stroke self-management programs available 
to implement in VHA for patients surviving stroke and TIA.                                                                 
Deliverables to Veteran Health Administration.  We have developed a stroke 
self-management program using core elements of a generic, evidence-based 
chronic disease program and infused the program with stroke specific elements 
based upon the input of key VA stroke stakeholders through a formal 
development evaluation. The programs include standardized manuals for the 
program provider and for the stroke/TIA survivor along with patient support 
materials (see Appendices 1 and 2). We have already fielded requests by front 
line VA nurses for stroke education materials. If our program demonstrates 
efficacy and later effectiveness, our ultimate goal is to assist the VHA in 
becoming a leader in high quality stroke care by implementing a stroke self-
management for veterans with stroke and TIA in VHA inpatient and outpatient 
services in order to reduce functional disability, reduce stroke risk factors, and 
improve stroke specific quality of life. With future implementation across VA 
facilities nationwide in mind, we will upload all program materials into the VA 
Stroke QUERI toolkit that is available online and promoted in our dissemination 
efforts to clinical neurology providers in VA. Thus, the deliverables to the VA from 
the proposed project are: 1) an evidence-based stroke self-management 
program including its standardized materials for VA providers and patients; 2) a 
formative evaluation of patient barriers and facilitators to stroke self-
management.  
The audience for the information generated as a result of this study includes VA 
researchers, managers, clinicians, nurses, social workers, health psychologists 
and veterans themselves along with their caregivers. VA researchers, particularly 
health services and implementation researchers (including QUERI investigators) 

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will use our findings about stroke self management and risk factor reduction to 
inform the design of implementation projects including the use of tailoring 
strategies based upon resources and staffing. VA managers will use our data to 
plan similar projects or to extend risk factor management and self-management 
program to other high risk groups of veterans.  As the patient medical home 
interest in VA becomes more widespread in VA, the standardized program 
provides an opportunity for specialized outpatient care to collaborate with primary 
care services. Clinicians may use our data to stimulate and inform efforts at their 
own facility to increase stroke risk factor management and patient post stroke 
self-management and potentially reduce the occurrence of future strokes. 
Veterans will find our stroke self-management program and support materials 
helpful in defining the best care after stroke and improving their management of 
risk factors and maintain their community roles. In addition, the additional support 
from the program may increase Veteran stroke patient satisfaction with VHS. 
Significance for the Veteran Health Administration. Stroke affects at least 
60,000 veterans each year and this number will likely increase as the veteran 
population ages. According to the ASA, the prevalence of stroke is expected to 
double by 2020 with the increased proportion of older adults nationwide. Our 
previous QUERI work indicates that stroke risk factors are often undermanaged 
by VHA. Our proposed study provides VHA with an evidence-based tool for 
implementing VA/DoD guidelines on secondary stroke prevention. Moreover, the 
proposed project will evaluate the program in 3 facilities with small, medium and 
large volume of stroke patients that will enable us to plan the tailoring of the 
program to accommodate the structure of VA neurological services across VHA. 
Furthermore, as VHA sets up its Patient Care Medical Home Labs with a focus 
on patient self-management and behavioral health, our stroke self-management 
program offers a standardized program with support materials for health 
psychologists and care managers to use for stroke survivors in outpatient care.  
 
Preliminary Studies          
 Prior work that informs this project. We have conducted several studies that 
provide critical background and data that led to the development of our stroke 
self-management program, inform this project, and illustrate how this project is a 
natural next step in our goal to improve the quality of care for veterans with 
stroke. In addition, our recently completed pilot study of our stroke self-
management program provides key insight into the design and delivery of our 
proposed intervention. Dr. Damush has also conducted a successful study of a 
self-management intervention for primary care patients with low back pain, which 
informs our design of the lifestyle modification module. 
 Randomized controlled trials. Dr. Damush was a co-investigator on a stepped 
care project for veteran and non-veteran patients with musculoskeletal pain of 
the low back, hip or knee and with depression.  Dr. Damush developed the pain 
self-management protocol, trained the nurse case managers, and directed the 
implementation of this portion of the intervention. From this study, we bring the 
experience of delivering a medication and lifestyle modification program in the 
VA outpatient care setting adjuvant to primary care services. The co-investigator, 

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Dr. Williams, has recently completed an NIH-funded study investigating the 
effectiveness of an antidepressant case-management intervention vs. usual care 
in the treatment of post stroke depression.  From this study, which completed 
enrollment of more than 400 stroke survivors and 250 family caregivers, we have 
gained important knowledge and experience that inform our study design in 
terms of identifying stroke patients at the time of hospitalization, successfully 
following them for as long as nine months post-stroke, interacting with our 
existing VA clinic systems to conduct the study, and detecting and managing 
symptoms in the post-stroke period. Moreover, IU Health Methodist Hospital in 
Indianapolis was one of the study sites for which our Research Coordinator, Ms. 
Gloria Nicholas, BSN, was the lead case manager. From this experience we 
have maintained a professional relationship with this local site which has become 
a primary stroke center certified by the Joint Commission and has agreed to be a 
local site for this proposed project.  
 Qualitative Research. Our team has also used focus groups to assist in the 
design and evaluation of primary care-based interventions. We completed 12 
focus groups of veteran stroke survivors (6 groups had strokes and the other 6 
had TIAs) at Indianapolis and Houston VAMCs. We queried participants and their 
family caregivers on stroke risk reduction practices, preferences, barriers 
encountered, provider assistance, and use of existing tools to assist with this 
management. Participants discussed their awareness and use of 
nutrition/dietician services, blood pressure home monitoring machines, smoking 
cessation preferences, and medication adherence strategies, lack of physical 
activity, anger management classes, and stress management techniques.  The 
stroke survivors indicated that they were more willing to change behavior and 
manage stroke risk factors after the stroke, indicating that experiencing a stroke 
was indeed a teachable moment for stroke risk factor management.  
Patient readiness to change – Across the groups, stroke survivors discussed 
what risky behaviors they stopped after experiencing a stroke as the stroke 
became a teachable moment. Indeed, some veterans who reported experiencing 
multiple stroke events said those events influenced them to change their 
behaviors. In sum, we have a multidisciplinary team with extensive experience in 
interview and focus group conduct and analysis, and intervention development.  
Finally, our team is experienced in conducting focus groups and semi-structured 
interviews for stroke research, including some recent examples that directly 
inform our design.   
Stroke Self-Management Pilot Study                                                                                           
As a secondary objective of a VA IIR on the Detection and Treatment of Post-
Stroke Depression (PI – Williams LS and Co-PI – Damush TM), we pilot tested 
our stroke self-management program at two VAMCs (Indianapolis and 
Gainesville, Florida). The objective was to pilot test the effect of a self-
management intervention to help patients manage post-stroke symptoms. 
Design. We employed a prospective, randomized, outcome-blinded design to 
assess the impact of a self-management program vs. usual care among veteran 
stroke survivors at the two facilities. Outcomes were assessed by trained 
interviewers blinded to treatment assignment. Participants were identified during 

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admission for ischemic stroke and were randomized in blocks of four, stratified by 
site and by receipt of inpatient rehabilitation (as a marker of stroke severity), to 
the patient self-management intervention or usual care intervention. Enrollment 
took place within a month of stroke discharge. Participants were consented using 
standard procedures in compliance with local IRB and VA guidelines. 
 
Intervention: The program applied theoretical concepts of Bandura’s Self-Efficacy 
to the intervention components: Verbal Persuasions (e.g. doctor 
recommendations), Social Modeling/Vicarious Experiences (e.g., learning from 
other stroke patients experiences), Past Achievements (e.g., smoking relapse), 
and Reinterpretation of Sensations/Physical State (e.g. use of distraction and 
relaxation methods to thwart depression and anxiety). Participants received 6 
biweekly telephone sessions to deliver the stoke self-management program or a 
placebo telephone call program that mimicked the intervention schedule.  
Sessions targeted primary outcomes of stroke self-management, and secondary 
outcomes of self-efficacy. The self-management program followed a 
standardized manual (placebo call simply asked how the patient was doing), and 
interviews were conducted at 3 and 6 months with a booster call at 4.5 months. 
We based our self-management intervention on the Stanford Self-Management 
Program, a program centered on enhancing patient self-efficacy to manage 
symptoms.  
 
Based upon the underlying theory and the results of our formative evaluation, we 
created a menu of stroke self-management topics that were incorporated into a 
6-session program with a written standardized manual delivered bi-weekly 
primarily by telephone. The topics included: expectations after stroke; 
negative/positive thinking; addressing fears; meaningful activities; follow up 
medical visits; communication with providers and caregivers; adapting/coping 
with disabilities; medication adherence; physical activity to improve mood and 
energy; access to community resources; and stroke risk factor modification. Each 
session targeted building self-efficacy using goal setting and behavioral 
contracting. Each patient was coached to choose at least one specific goal to 
work on in each session, including the specifics of when, where, and for how long 
they would do the specific behavior. Patients rated their confidence in carrying 
out each behavior and were encouraged to only select behaviors that they rated 
a 7 out of a possible 10 (completely confident in doing). In the follow-up 
telephone calls, patients received individualized feedback about their progress 
toward their selected goal(s) and were encouraged to continue to work on the 
chosen behavior or to select or add a new behavior goal.  
 
 
Enrollment, consent and other patient variables were collected at baseline (prior 
to hospital discharge or within four weeks of discharge). Outcomes were 
collected via telephone at three months and six months post-enrollment.  
Patients assigned to usual care received stroke education pamphlets and a 
general stroke education session at enrollment, and phone calls to assess stroke 

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symptoms (with no self-management training) at identical time points as 
intervention patients as an active attention control. 
 
Results. We enrolled 63 veterans with stroke into the pilot program (41 from the 
INVAMC and 22 from the GVVAMC). The intervention and control groups did not 
differ on age, race, sex, or on percent living alone. The groups also did not differ 
on the admission NIH Stroke Scale (3.3 intervention vs. 3.3 control) indicating the 
participants had on average minor stroke severity. Although not statistically 
different, the intervention group had slightly higher baseline depression symptom 
scores than the control group (mean PHQ9 6.5 vs. 4.2). 
 
Stroke Self-Management Intervention Processes. Of the six planned 
sessions, the average number of sessions completed by the intervention group 
was 5.0 and the average number of attention sessions completed by the control 
group was 5.7. The session rates completed did not differ by site. The most 
frequent activities reported in the behavioral plans by those in the intervention 
were the following: became active around the home; walked in the community; 
took pills as doctor recommended; ate healthy foods and eliminated unhealthy 
foods; practiced other physical activity and listened to relaxation CD. 
Self-efficacy. Baseline mean score for the self efficacy measure of 
Communicating with Physician in the intervention group was 8.5 vs. 8.9 in the 
control group (p > 0.05). Mean change from baseline was significantly different 
between groups at the second follow up visit (intervention group with mean 
increase in confidence of 0.5 points vs. control group mean decline of 0.8 points.  
Model based estimates controlling for intervention group and visit also showed a 
significant difference in mean self efficacy of communicating with a physician at 
the 2nd follow up visit (p-value = 0.0231).     
Self-Management behaviors. Participants in the intervention group 
reported an increase in time spent in aerobic activity compared to the control 
group. At 3 months the intervention group demonstrated a mean increase in 47.6 
minutes in intervention compared to a mean decrement of 3 minutes in the 
control group (p = 0.13); this effect was sustained at 6 months (increase in 24.4 
minutes in the intervention group compared to increase of 4 minutes in control 
group, p = 0.50), although these differences were not statistically significant.  
Stroke Specific Quality of Life. At baseline, subjects in the intervention 
group had significantly lower (worse) mean scores for several SSQOL scales 
including Mobility, Thinking, Energy, and Work as well as SSQoL overall score. 
This imbalance is likely due to the relatively small sample size in this pilot study. 
Mean change from baseline in SSQoL Family roles (baseline intervention mean 
score = 3.6 and control mean = 4.2) was significantly different between groups at 
the 3 month follow up visit. On average subjects in the Intervention group 
showed an improvement of 0.5 points, while subjects in the control group showed 
a decline of 0.3 points.  Model based comparisons at this time point were also 
different; however, this difference was only marginally significant with p-value 
0.052.                                

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Mean change from baseline for SSQoL Social roles scores (baseline 
intervention mean score = 3.1 and control mean = 3.6) was significantly different 
between groups at the first follow up visit (intervention group improved by 0.3 
points vs. control group decreased by 0.4 points).  Model based comparisons 
also showed a similar difference at the first follow up visit with p-value = 0.04.  
Similar estimates of mean change from baseline of SSQoL Work scores were 
also significantly different between groups at the 6 month visit.    
 
Self-management intervention impact and context. This study is one of the 
first to test the efficacy of a stroke self-management program that was developed 
with input from key stakeholders (i.e., veterans with stroke, caregivers, and 
clinical providers of stroke care). Currently, there are no other published results 
from a stroke specific self-management program. Our process measures indicate 
that offering a stroke self-management program after stroke is feasible. However, 
recruiting strictly from the acute stroke phase can limit the reach of this program 
into the veteran population, especially for VA facilities that provide less acute 
inpatient stroke care but may provide significant stroke rehabilitation or follow-up 
care. Although our sample size limited our statistical power to detect an 
intervention effect, we observed consistent differences in patient self-efficacy and 
stroke specific quality of life suggesting that the program has the potential to 
improve the quality of life of veterans with stroke. We employ this data to design 
and evaluate the efficacy of a more focused stroke self-management program 
(this proposed IIR).                                                                                                      
Conclusions/Impacts. The results of this study demonstrate feasibility in 
participating in a self-management program for veteran stroke survivors. 
Veterans with stroke may have some unique needs for self management support 
for some issues including feeling confident and comfortable enough to leave the 
home and participate in the community after stroke. A lack of transportation 
services and difficulty with reading and writing after stroke may produce 
challenges in the process of learning self-management. Thus, we offer our 
program both in person and by telephone to meet the delivery needs of the 
veteran.  
 
LESSONS LEARNED FROM 
PREVIOUS RESEARCH 
IMPLICATIONS FOR THE PLANNED 
INTERVENTION 
Reasons for refusal to participate 
included needing time to adjust before 
participating in a program 
Extend the recruitment period from 4 
weeks to 12 months post stroke to 
account for the patient’s readiness to 
change. 
Short- term improvements in self-
management reverted back to baseline 
after program ended 
Extend the program from 3 months to 6 
months to foster behavioral change. 
Family role, Social role, and Work role 
functioning improvements were 
associated with intervention 
assignment. 
Establish these outcomes as our 
primary outcomes of the trial and target 
the intervention to increase focus on 
these roles. 

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Reading and writing after stroke may 
be problematic for some stroke 
survivors. 
Created a behavioral checklist to simply 
goal setting form. 
Walking and working around the home 
were the most frequently report 
physical activities 
Promote these activities in the exercise 
and physical activity component of the 
intervention. 
Cell phone minute use to interact with 
staff was problematic for some 
veterans 
Provide compensation for completing 
research assessments. 
Stroke survivors desire for fellowship 
from similar stroke survivors. 
Include monthly stroke support group 
during months 4-6. 
C4. Theoretical Framework.  We employ the principles of Social-Cognitive 
theory 51 to guide the development of the intervention elements that target patient 
self-efficacy, processes, and outcomes (Figure 1). 
 
 
C.4b  Social Cognitive Theory and Patient Self-Management: We will base our self-management 
intervention on the Stanford Self-Management Program, a program centered around enhancing patient self-
efficacy to manage symptoms.29,38 Self-efficacy, defined as the level of confidence in one’s ability to 
perform a specific behavior, is a concept within social cognitive theory and is the link between knowledge 
and action.51  Patients may possess health knowledge, but may perceive themselves as incapable of 
performing health behaviors. According to social cognitive theory, a person’s behavior is predicted by the 
confidence in ability to perform a specific behavior in a given situation and the outcome expectations of 
behavior performance.51,52  Bandura suggests that we are constantly processing, evaluating, and 
reevaluating information about our strengths and weaknesses, which form the basis for perceptions of 
abilities (i.e., self-efficacy). We evaluate even more when we encounter problems or new situations. Self-
efficacy, in turn, affects the behaviors we choose or avoid and the amount of effort put forth to perform 
those behaviors (e.g., treatment adherence).  
 
Self-efficacy perceptions are influenced by a variety of cognitive 
determinants, including: 1) verbal persuasion; 2) past experiences or 
performance accomplishments; and 3) vicarious experiences or learning through 
observation of events or other people. We will specifically address these 
cognitive determinants in our self-management program.   Physiological states 

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also provide information to the person that may affect self-efficacy so we will 
assess patient-perceived symptoms as potential mediators of the intervention. In 
addition, we will employ this framework to guide our outcomes measurement and 
planned evaluations.          
 
 
 Research Design and Methods 
 
STROKE SELF-MANAGEMENT STUDY DESIGN AND EVALUATION 
RECRUIT 
BASELINE 
RANDOMIZE 
INTERVENTION 
(6 months) 
3  
MONTHS 
6 
MONTHS 
12 
MONTHS 
 
ASSESSMENT 
 
CONTROL 
ASSESSMENTS 
 
Study timeline (see Gantt Chart): The study is planned for four years. We will 
devote our efforts to start up and training during the first 3 months of year 1 and 
then proceed with recruitment during Months 4 – 30. We will conduct follow up 
assessments through Month 42. We will finish year four with analyses of the 
intervention and a summative evaluation to guide our next phase of implementing 
the stroke self-management program. 
 
2.0 
Rationale and Specific Aims 
Stroke is prevalent, costly and associated with increased long term 
disability, morbidity and mortality. Despite advances in the prevention and 
acute management of stroke, many patients do not receive high quality 
stroke care and there is wide variation in the transitional points of care 
across the continuum of stroke. Veterans with a stroke or transient 
ischemic attack (TIA) are at elevated risk for future vascular events within 
90 days and death within the year. The VA/Department of Defense (DoD) 
and Joint Commission (JC) stroke clinical care guidelines promote the 
management of risk factors to prevent secondary stroke events. Yet, 
there are no post stroke programs designed and systematically offered to 
reduce this risk, and increase stroke, specific quality of life among 
veterans after discharge from VA.  
 
Our previous research with key VA stakeholders, veterans and their 
caregivers, identified the recovery period after stroke as stressful and 
taxing as they attempt to self-manage their health with residual 
disabilities, navigate the VHA healthcare system, and cope with the loss 
of functioning and roles (family, social, work) and the consequential social 
isolation. 
 
While disease specific programs exist for chronic conditions such as 
diabetes or specialty clinics are available for specific conditions (e.g., 
hypertension, anti-coagulation), to our knowledge, there are no published 
evaluations of stroke-specific self-management programs. Thus, we lack 
an evidence-based program to address the identified needs of veterans 
with stroke/TIA. We developed and pilot tested a stroke self-management 

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program that incorporated the general core elements of the Stanford 
University Chronic Disease Self-Management program and added stroke 
specific elements based on the results of our formative developmental 
evaluation with key VA stroke stakeholders. Our pilot test study 
demonstrated positive trends in self-efficacy, self-management and risk 
management behaviors, and stroke specific quality of life. We plan to 
incorporate the lessons learned from the pilot study to more rigorously 
test the effect of a stroke self-management program on functioning, 
stroke specific quality of life, and risk factor management in a randomized 
controlled trial. Our ultimate goal is to establish an evidence-based stroke 
self-management program to implement in VHA. The specific aims of this 
project are: 
 
Primary Aim 1. To determine the effect of a stroke self-management 
program on stroke specific quality of life at 3, 6, and 12 months. 
 
Secondary Aim 2. To determine the effect of a stroke self-management 
program on process factors: self-efficacy and self-management behaviors 
at 3, 6, and 12 months.   
 
Secondary Aim 3. To conduct a summative evaluation at 12 months to 
understand patient barriers and facilitators to stroke self-management. 
 
To evaluate these specific aims, this study will test the following 
hypotheses: 
Hypothesis 1. Compared to subjects randomized to usual care, 
participants with stroke/TIA who are randomized to the stroke self-
management intervention will demonstrate better stroke specific 
functioning and quality of life at 3, 6, and 12 months. 
Hypothesis 2. Compared to subjects randomized to usual care, 
participants with stroke/TIA who are randomized to the stroke self-
management intervention will report. 
 
3.0 
Inclusion Criteria 
•  age 18 or older, 
•  acute diagnosis of ischemic stroke or TIA within past 12 months,   
•  able to speak and understand English,  
•  no severe cognitive impairment,  
Our language and cognitive screening strategy is identical to that 
which we have successfully employed in our NIH-funded post-
stroke depression study and our pilot study.  The cognitive 
screening is designed to allow patients with moderate cognitive and 
language effects of stroke to be included in the study. This is 
important because these stroke effects are critical impairments that 
impact patients and their families and may also impact the success 
of the intervention.  Cognitive screening will be done with Short 

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Portable Mental Status Questionnaire which assesses short- and 
long-term memory and orientation. This screener has been 
validated in a study of older community dwelling adults and we 
have also successfully used this screener in our VA study of PSD. 
All patients with a score > 6 will be enrolled, as this score has 
previously identified patients without severe dementia, which would 
decrease reliability of self-reported symptoms and satisfaction, 
while allowing the inclusion of patients with cognitive effects of 
stroke. Language screening will be done with the National 
Institutes of Health Stroke Scale, commands and language 
questions. Patients with significant language comprehension 
(commands score > 0) or receptive language deficits (aphasia 
score > 2) will be excluded. 
•  access to a telephone,  
•  willing to follow-up in VA/IU Health/Wishard outpatient care,  
•  willing to attend all individual phone and group meetings during the 6 
month intervention,  
•  life expectancy of at least 6 months as defined by the patient’s treating 
clinical provider, 
• No documented personality disorder diagnosed by a health professional, 
• Ability to self-manage, 
• No active alcohol and/or substance abuse, 
• No end stage renal disease on dialysis. 
 
4.0 
Enrollment/Randomization 
 
We will obtain written consent and enroll patients into this randomized controlled 
trial. Patients interested in participating in the study will be consented using 
standard procedures in compliance with local Institutional Review Board, HIPAA 
guidelines and VA R & D Committees. Patients would be given the opportunity to 
be consented via telephone and sign the written informed consent statement and 
HIPAA form by mail. All patients will receive a copy of the informed consent form, 
written in 6th grade English or less, and will be given time to read it or have it read 
to them and to ask questions.  For all potential study subjects, permission to 
discuss the study with the patient will be obtained from the attending physician 
prior to recruitment.  Methodist, Wishard, Roudebush, and Jesse Brown patients, 
who do not wish to participate in this study, will be excluded. Our investigators 
have extensive experience in recruiting stroke / TIA survivors for studies and are 
well-integrated into the local clinical and research culture at their respective 
facilities. 
 
Indianapolis study team would also assist Jesse Brown study site to recruit, 
consent, administer assessments and conduct study intervention with Jesse 
Brown patients over the phone and via mail. 
 

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Retrospectively - We will use a modification of Reker’s high specificity algorithm 
to identify patients hospitalized with acute ischemic stroke. Specifically, primary 
position admission ICD-9 codes related to ischemic strokes and TIAs (DXPRIME 
from PTF main) have been demonstrated to have at least 88% sensitivity and 
90% specificity for identifying patients with acute ischemic stroke. These ICD-9 
codes will be extracted from PTF main to identify the study sample in the VA and 
from INPC (Indiana Network for Patient Care) data by Regenstrief for the 
Methodist and Wishard patients. We will apply this algorithm retrospectively to 
identify Roudebush veterans meeting the study criteria during the past 12 months 
during the beginning of recruitment phase given that we are recruiting 
prospectively up to 12 months post discharge. We will add time since stroke 
event at baseline as a covariate in the analyses to control for this time effect. We 
have used these criteria successfully in past qualitative and administrative data 
research. 
 
 Prospectively - Subjects will be identified during their stroke/TIA admission at   
Methodist Hospital, Wishard Hospital and Roudebush.   Indianapolis study 
personnel at each site will conduct daily screenings of neurology, medicine, and 
rehabilitation admissions (including review of electronic medical record and/or 
written admission logs and verbal contact with providers) to identify all patients 
with acute ischemic stroke/TIA at Methodist, Wishard and Roudebush VAMC.  
 
We will obtain written consent and enroll retrospective and prospective patients 
into this randomized controlled trial at Methodist, Wishard and Roudebush. 
Patients interested in participating in the study will be consented using standard 
procedures in compliance with local IU Institutional Review Board, HIPAA 
guidelines and Roudebush VA R & D Committees. Patients would be given the 
opportunity to be consented via telephone and sign the written informed consent 
statement and HIPAA form by mail. All patients will receive a copy of the 
informed consent form, written in 6th grade English or less, and will be given time 
to read it or have it read to them and to ask questions prior to being consented. 
 
We will use a stratified block randomization scheme. Randomization will be 
conducted with each stratum defined by site and stroke/TIA diagnosis. With each 
stratum, participants will be randomized by blocks of size 8. In other words, we 
will randomly assign equal number of participants in each block into the 
intervention or control group (i.e. 4 in intervention and 4 in control group). 
Randomization by blocks is used to ensure balanced number of subjects in two 
arms.  
 
For the exit focus groups, we will take a random sample of approximately 25% of 
the study intervention subjects from each site and invite those participants o 
participate in an exit focus group. A total of up to 108 intervention subjects from 
Methodist, Wishard, Roudebush and Jesse Brown will be invited.  We plan to 
hold -up to 9 groups with  6-10 participants per focus group. At each site, one 
group will consist of subjects who completed all of the 12 week stroke self-
management program to best understand compliance and motivation and the 

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other group will consist of subjects who completed less than the 12 week program 
to best understand their barriers. Two groups will be comprised of Jesse Brown 
participants, two groups will target Methodist participants, two groups will be 
comprised of Wishard participants and the remaining two groups will be comprised 
of participants from Roudebush VAMC.  Each focus group will meet once for up to 
two hours.  Sessions will be held in a conference room located at Jesse Brown VA, 
Roudebush VA, Wishard Hospital and at Methodist hospital, so that the location is 
easily accessible and familiar.  In the past, we have made transportation 
arrangements for participants and will do the same for participants in this study.  
Participants will be reminded by telephone one week before, and again two days 
before the focus group.   
 
5.0 
Study Procedures 
 
Before study activities commence approval from IU IRB will be obtained followed 
by Roudebush VAMC Research and Development Committee approval.  Once 
all the necessary regulatory approvals are obtained we will commence this study.  
We will conduct a randomized controlled trial comparing subjects randomly 
assigned to the stroke self-management intervention to subjects randomly 
assigned to usual care. Subjects from both groups will be assessed at baseline, 
3, 6, and 12 months. The stroke self-management program will be delivered over 
6 months (12 weeks biweekly sessions followed by 12 weeks of bimonthly 
telephone and group support sessions). Usual care participants will receive 
written stroke risk factor materials. Our primary outcomes will be stroke specific 
quality of life and our secondary outcomes will be stroke self-management, self-
efficacy, functioning, and post stroke depression. Additionally, we will hold focus 
groups with approximately 25% sample of intervention subjects from each site to 
best understand their barriers to participation and suggestions for future 
implementation. At each site, one group will consist of subjects who completed all 
of  the 12 week stroke self-management program and the other group will consist 
of subjects who completed less than the 12 week program.  The focus groups will 
be audio taped after participants have consented to be audio taped per VA and 
IU requirements. 
 
Patient self-management intervention                                                                                 
5.a. Stroke Self-Management Program (SSMP) Overview: The stroke self-
management program (SSMP) to be used in this trial includes core elements that 
have been shown effective in a primary care trial of veterans with 
musculoskeletal pain and depression conducted by our team as well as arthritis 
trials.  In addition, we have added stroke specific elements based upon our 
needs assessment of stroke survivors and input from clinical providers and family 
caregivers. Importantly, the SSMP is designed to assist veterans in identifying 
and improving self-management of a variety of common post-stroke symptoms 
and issues. Items listed below in the SSMP menu were derived from our focus 
group discussions. 
As demonstrated in our pilot study, the SSMP will be delivered over 6 bi-weekly 
telephone or face to face sessions during the first 3 months and followed by 3 

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monthly reinforcement telephone sessions coupled with 3 monthly group 
sessions during months 4-6. The intervention subjects may choose to complete 
these sessions by phone or in person with the study care manager.  Additional 
telephone contacts will focus on reinforcing, monitoring, and adjusting the goals 
and self-management strategies (reinforcement calls). Support Group sessions 
and care manager telephone monthly call sessions during months 4-6 will 
promote maintenance. The first biweekly telephone or face to face session will 
take place after the baseline assessment is completed. The care manager will 
schedule subsequent sessions at a time convenient to the participant, every 2 
weeks during months 1-3. During months 4-6, participants will receive 1 monthly 
call and will be expected to attend 1 support group meeting. Outcomes will be 
collected via interview at three, six, and twelve months post-discharge.  
We have developed a detailed standardized program manual for all six self 
management sessions and included the following materials in the Appendices: 1) 
a detailed script for care manager which includes a summary of topics to be 
covered in the six sessions; 2) a patient standardized manual; and 3) a 
behavioral checklist for participant goal setting.  
  
In subsequent telephone or face to face sessions, patients will receive 
individualized feedback about their progress. In addition, patients are 
encouraged to ask questions of their provider, participate in decisions about their 
healthcare, and to use positive talk and relaxation, two coping strategies that 
have been successful to manage negative affect. In subsequent sessions, 
patients may continue to work on the chosen behavior or may select a different 
behavior goal. Participants’ chosen goals will be tracked by staff. 
To promote self-efficacy, the program begins with patient education on the 
natural history of stroke and the rehabilitation process, emphasizing the potential 
outcome expectation for improvement over time.  This is designed to enhance 
patients' optimism for improved function and coping, but provide realistic 
expectations regarding disability.  Common diagnostic and treatment strategies 
will be discussed.  Post stroke symptoms and treatment strategies will be 
discussed as stroke survivors from the focus groups frequently mentioned that 
they did not recognize the symptoms of depression.  The instructor will promote 
behaviors based upon current evidence-based treatment recommendations 
found to have at least moderate support in the medical literature. In addition, 
patient education materials will show recommended exercises of stroke 
rehabilitation, including walking to improve mood and decrease fatigue. Patients 
are encouraged to adhere to their physicians' treatment recommendations, as 
well as to reduce their body weight (when appropriate). Another key issue 
identified from the focus group included adapting to a significant role change. 
Survivors and caregivers both reported a need to help the stroke survivor create 
a schedule or have something to do. We will incorporate the principles of 
behavior change to modify daily schedules of stroke survivors. To promote 
behavior change, the program includes goal setting and problem solving. Barriers 
to engaging in these behaviors are discussed.  During the planned meetings, 
patients will be educated on the benefits of physical activity for stroke and 

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depression management as well as the benefits of other strategies presented. 
Participants will be encouraged to develop an overall goal that they wish to 
achieve. 
 
Self-Efficacy Theoretical 
Concepts 
Mapped Stroke Self-Management Strategies 
1. Verbal Persuasions 
• 
Staff and lay leader explanations  
• 
Promotion of physician and therapeutic 
recommendations 
2. Social Modeling/Vicarious 
Experiences 
• 
Staff and lay leader demonstration of all strategies 
and new behaviors 
• 
Peers practice behavior in group meetings and 
share vicarious experiences 
• 
View material depicting stroke patients similar to 
them 
3. Past Achievements/Failures 
• 
Set realistic, achievable behavioral goals 
• 
Past failures may influence current level of effort so 
plan to overcome past failures. 
• 
Gain an understanding of the course of stroke 
rehabilitation and realistic outcome expectations 
• 
Negotiate the effort placed into cardiovascular risk 
factor modification 
 
4. Reinterpretation of 
Sensations/physical state 
• 
Discuss symptoms and how to diminish 
• 
Employ distraction methods – mental imagery 
• 
Employ relaxation techniques 
 
Strategies to achieve these goals will be presented during the support group 
meetings. Patients will be encouraged to attempt incorporating strategies 
presented in group sessions or telephone meetings outside on their own. To 
increase self-efficacy, patients will set weekly, small behavioral goals that will 
eventually lead them to achieve their overall goal. The goals should be easy to 
accomplish and the patient should feel confident that she could achieve this goal 
over the next week. It is important for patients to succeed in obtaining their small 
goals (i.e., achieve mastery). This success builds self-efficacy and motivates 
future behavior performance. Patients will verbally commit to a goal each week, 
record this commitment on a behavior contract, attempt to achieve their goals in 
between class sessions, monitor and record behavior, and report back during the 
next session on their successes or barriers encountered. The support group will 
provide encouraging feedback and help patients with problem-solving to 
overcome their barriers. These methods improve self-efficacy by providing 
feedback and eliciting solutions regarding barriers from patients rather than the 
group leader. Patients learn to help themselves and understand the process of 
finding solutions in order to modify behavior long-term.  In addition, sharing 
success stories provides patients with positive behavior models and vicarious 
experiences, thus enhancing self-efficacy. 
 
According to Social Cognitive theory, increased patient self-efficacy to self-
manage their stroke symptoms and to perform stroke self-management 

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behaviors will empower the patient to engage in stroke self-management. 
Increased stroke self-management therefore is proposed to improve patient 
outcomes: functional status and stroke specific quality of life. 
 
5.c  Telephone calls: the purposes of the telephone calls in the self-management 
program are twofold. First, the 6 bi-weekly self-management intervention 
sessions will be delivered by telephone during the first 3 months as we did in our 
pilot study given that transportation and mobility barriers may hinder in-person 
participation. Second, we will provide feedback and assist with goal setting 
through bi-weekly telephone follow-up during months 1-3 and then monthly 
during months 4-6. Calls will address the chosen behavior goal, self-
management strategies, and assess progress. We will help the patient problem-
solve and identify successes, and to modify goals and strategies appropriately. 
At all calls we will ask patients to describe their current practice of chosen self-
management behaviors by type, frequency and duration. The staff will record 
these practices and track in our database.  
5.d. Quality Control. As we have previously done in prior studies, Dr. Damush will 
observe a random sample of SSMP sessions by all instructors to insure the 
fidelity of the program. We will utilize teleconferencing with the participant’s 
permission to have the call monitored during the session for quality control 
purposes as we did in our pilot study. Dr. Damush will provide feedback to the 
instructor as needed. 
5.e  Support Group sessions: The SSMP sessions are based on Social-Cognitive 
theory and focus on increasing self-efficacy and social support to self-manage 
symptoms after stroke.  Participants will discuss goals and problem-solve to 
sustain behavioral change.  Study staff will conduct the group SSMP sessions 
using a standardized, written protocol. Since our focus group participants from a 
prior research study comprised of stroke survivors stated that it was helpful to 
hear from other stroke survivors, we will utilize the group sessions for stroke 
survivors to share their successes and to help problem solve each others’ issues 
around stroke self-management and recovery. The Roudebush VA research staff 
will provide the program for Wishard and Methodist participants as well given the 
close proximity and their previous experience in doing so. Ms. Gloria Nicholas, 
project coordinator and case manager, will train the Jesse Brown research staff 
and provide monthly support as needed as she has previously done in our 
previous research with staff located at external research sites. Participants 
enrolled in the intervention will be expected to participate at least one quarterly 
support group session during months 4-6 months of their study participation.  It is 
anticipated each support group sessions will last 1 -1.5 hours.  
 
After the completion of the 12 month assessment/interview, we will invite 
intervention participants, who had attended at least 1 Stroke/TIA Support Group 
while in the study, to attend the Stroke/TIA Support Group after they are finished 
with the study. At the completion of the 12 month assessment/interview, we will 
ask all participants in the intervention and control groups whether or not they are 

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interested in attending the Stroke/TIA Support group. Only those who say yes will 
then get invited for subsequent support group meetings. 
 
5.f  Exit Focus Groups:  Focus groups are carefully planned group interviews 
guided by a facilitator to understand people’s experiences on a given topic. They 
are ideal for understanding health care issues because group interaction produces 
insights that often do not surface in individual interviews.  The recommended 
method is to assemble people who have similar characteristics and experiences.  
Self-disclosure increases when participants can empathize with one another.  
In order to formally evaluate the process of implementation of the stroke self 
management program, we plan to conduct study focus groups during the last 
year in the study. The goal of these focus groups is a summative evaluation of 
participant barriers and facilitators.  The goal of this evaluation is to optimize 
implementation to improve potential for success. We will identify high and low 
stroke self-managers based upon program participation and our secondary 
outcomes and invite them to participate in an exit focus group.  We will query 
participants on their barriers and facilitators of participating in the program, 
perception of the components, identification of helpful and burdensome modules, 
and recommendation for improvements to the program. Data from the formative 
evaluation may lead to implementation improvement during the next phase of 
implementation, a regional, multi-site trial. 
 
C. We estimate holding 6-9 focus groups of approximately 6-10 participants per 
group. At each site, one group will consist of subjects who completed all of  the 12 
week stroke self-management program and the other group will consist of subjects 
who completed less than the 12 week program. Two groups will comprise of Jesse 
Brown VA Chicago participants, two groups will target Methodist participants, two 
groups will comprise of Wishard participants and the remaining two groups will 
comprise of participants from Indianapolis Roudebush VAMC.  Each focus group 
will meet once for up to two hours.  Sessions will be held in a conference room 
located at Jesse Brown VA, Roudebush VA, Wishard Hospital and Methodist 
Hospital, so that the location is easily accessible and familiar.  In the past, we have 
made transportation arrangements for participants and will do the same for 
participants in this study.  Participants will be reminded by telephone one week 
before, and again two days before the focus group.   
At the beginning of each focus group, the moderator will explain the procedures 
and discuss patient confidentiality. Only first names will be used during the taped 
conversations to retain patient confidentiality. Dr. Damush, a trained qualitative 
researcher and moderator, will moderate the groups as she has done for her 
recent Veteran study.  
5.g  Usual care:  Stroke and TIA survivors randomized to usual care will only 
receive written patient education materials on the stroke warning signs and 
pamphlets from the American Stroke Association on preventing secondary 
strokes. This is the current standard stroke/TIA education materials.  There are 
no current stroke self-management programs at Methodist, Wishard, Jesse 
Brown or Roudebush, so the potential for contamination is minimal. We will not 

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provide any telephone contact or self management materials during the 
intervention period to the usual care subjects except for contact to complete 3, 6 
and 12 month assessments.  Usual care subjects will be contacted by phone, in 
person or in certain situations by mail by study staff to complete these 
assessments.  
5.h  Adverse Events of the SSMP: If participants experience chest pain, 
shortness of breath, or dizziness, they will be instructed to cease activity and see 
their physician immediately if these symptoms persist or recur with further 
activity. The support group meetings will be held at the Roudebush and Jesse 
Brown VAMCs, Wishard Hospital and Methodist Hospital where access to 
emergency care is available 24 hours per day. All personnel will be trained in 
assessment and triage of symptoms post-stroke, and Ms. Nicholas has been 
successfully managing patients in this setting under the supervision of Drs. 
Williams and Damush during the past ten years. Per IRB protocol, all adverse 
events will be reported by the project coordinator/Care Manager to the IRB/VA R 
and D committee and VA research compliance officer. 
5.i  Dose and success of the SSMP: We will track attendance at all group 
sessions and telephone calls completed using a computer database to record the 
received dose of the SSMP. We will also assess patient adherence to their 
chosen self-management behaviors. 
6. Data Collection Protocol                                                                                                        
Below we outline the data collection protocol, including the variables that will be 
measured, how and when they will be assessed. Each assessment will take 
approximately one hour (see Appendix ). Interviews for the self-management 
intervention component will be conducted by blinded staff.  As in our previous 
studies, we will complete the assessments in person at the hospital, by 
telephone, or by mail. For those, who are unable to travel to the hospital, our 
research staff will travel using a government issued vehicle to the patient home 
within a 2 hour limit to complete to insure adequate follow up rates. Often, stroke 
survivors are not able to drive in the immediate months after the stroke event. 
Based on our pilot study, we have extended the intervention period from 3 to 6 
months. Indianapolis study team will access patients’ medical records for all 
study sites including Jesse Brown VAMC, to pull data or abstract data on 
healthcare utilization, functional status, and stroke quality improvement 
processes at the time of the stroke/TIA event and during the study participation 
period of all enrolled patients from all study sites. If a participant withdraws we 
will record the reason provided and as listed in the informed consent, we will 
attempt to contact to complete the remaining assessments. Data will be analyzed 
on an intention to treat basis. 
6.a. Measures: Primary Outcomes: Stroke specific, health-related, quality of life. 
Stroke specific quality of life will be assessed with the SS-QOL. This 62-item 
instrument assesses 12 domains relevant to stroke patients including energy, 
mobility, work, upper extremity function, ADLs, family roles, social roles, vision, 
language, thinking, mood, and personality. Our work has shown that the SS-QOL 
has good psychometric properties and that it provides a more meaningful 
assessment of overall post-stroke HRQOL than the SF-36. Our pilot data 

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demonstrated that 3 domains of the SSQOL were sensitive to change after the 
pilot intervention: family roles, social roles and work role functioning. In addition 
to the separate domains, an overall score can be calculated. We hypothesize 
that stroke survivors randomized to the intervention group will improve 
significantly on the domains of SSQOL and the overall score compared to those 
randomized to usual care. 
 
 
Secondary Outcomes. Self-Efficacy; Stroke Risk Factor Self-Management 
Behaviors.  To evaluate the processes by which self-management programs 
affect health and quality of life, we included measurement of self-management 
behaviors promoted in the intervention program and self-efficacy to manage 
stroke symptoms and for carrying out self-management behaviors as developed 
by the Chronic Disease Self-Management Program.  Self-Management Behavior 
Frequency (e.g. minutes spent in aerobic, communicate with physician) will be 
assessed using validated scales designed to measure the frequency during the 
past week the patient engaged in the specific behaviors.   We have used these 
scales among patients with stroke and with chronic medical conditions.  Self-
management behaviors (e.g., stretching exercises, progressive muscle 
relaxation) were assessed using questions adapted from a set of measures 
developed for intervention programs and previously published studies about the 
frequency of engaging in physical exercise, cognitive, and relaxation strategies 
that were promoted in the self-management program.  More specifically, 
respondents were queried about the total time spent during the past week spent 
doing stretching and strengthening exercises, walking and other aerobic 
exercise. Item responses ranged from none to more than 3 hours per week, 
which were converted to number of minutes per week of exercise ranging from 0 
to 180 minutes. For cognitive strategies, we asked participants how often they 
practiced visualization or guided imagery, progressive muscle relaxation, positive 
thinking or positive self-talk when they were feeling pain or unpleasant 
symptoms. Response categories ranged from 0 (“never”) to 5 (“always”). The 
mean of each item reflected the strategy score. We will also ask how many days 
a week is typically spent in strenuous exercise and for how many minutes.  
Self-efficacy( i.e., confidence to perform specific behaviors) will be 
measured using established scales designed to measure a patient’s confidence 
level to manage stroke self symptoms, communicate with their providers, and 
engage in self-management behaviors (e.g. exercise regularly).  We have used 
these scales in our previous research where patient’s rate their self-efficacy on a 
1-10 scale where 10 denotes high self-efficacy. For example, in our pilot study, 
participants in the intervention reported a greater confidence to communicate 
with their physician and to exercise regularly at six months compared to the 
control group.  
Functional Status 
In addition to assessing self-reported function, we will conduct several 
performance measures to assess functional status. We will begin with the Six-

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Minute Walk Test.  If subjects are able to complete the Six Minute Walk Test 
without stopping, they will be asked to complete a Dual Task Walk Test. 
Six-minute walk test has been used extensively to demonstrate functional 
status across a wide range of patients with specific medical conditions and older 
adults. It has demonstrated reliability and validity. Participants are instructed to 
walk as fast as they can on a marked course over six minutes. Distance walked 
is the outcome. Our co-investigator, Dr. Schmid is currently using the six-minute 
walking test to evaluate functional status among stroke patients and has not 
experienced any adverse events during the testing. We will conduct this test at 
the hospital. Similar to Dr. Schmid’s methodology, we will measure off the 
walkway and mark it with cones as we conduct the timed walk.  
 
Stroke outcomes will be assessed by having patients rank themselves on the 
modified Rankin scale, a commonly used global stroke outcome measure that 
categorizes patients into five outcome groups from no symptoms at all to 
severely disabled.  In addition, our research staff is trained on assessing a 
retrospective NIH Stroke Scale for stroke patients using the patient medical 
record within 24 hours of admission.  Dr. Williams established the methodology 
and training module that our research staff has all been trained. This scale 
captures stroke deficits in several domains (consciousness, vision, extraocular 
movement, facial control, limb strength, ataxia, sensation, and speech and 
language) and is used as a measure of stroke severity. 
Covariates. Site will be coded dichotomously to control for local effects. 
Demographics. Age, gender, race/ethnicity, education, marital status and 
household income will be assessed during the patient baseline interview. 
Household income will be assessed with a single item used in primary care 
interventions, “Do you have enough income to get by?” Depression symptoms 
are measured by the PHQ-9, a 9-item depression screener tool (derived from the 
first two items of the PHQ-9) that assesses DSM-IV symptoms of depression: 
depressed mood and anhedonia, and perform well as a depression screener in 
primary care and in post-stroke patients.  We will include to control for post 
stroke depression. Co morbidity - Patient co morbidity will be extracted from the 
medical record and evaluated using the Ambulatory Care Groups (ACG).  ACG is 
a reliable and valid evaluation that we have used in previous trials from this 
population as a covariate. Co morbidity will be used as a covariate in the 
analyses.  
Screening for stroke risk factor management: We will examine CPRS records to 
determine the proportion of participants in goal of their stroke risk factors during 
the subsequent 6 months after the stroke event. The chart reviews will be 
conducted by the site research assistants. As we have previously done in our 
previous research, we have created a chart abstraction form that denotes all 
stroke risk factors and the targeted goals for stroke survivors and includes the 
following elements: cholesterol LDL < 100; Blood Pressure < 130/80; current 
smoking status; HgA1C levels if diabetic; INR if on anti-coagulation; weight/BMI; 
alcohol use.  We expect all patients to have fasting lipid profiles done during 

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hospitalization if not performed in the three months prior to stroke onset. We 
expect patients with diabetes to have hemoglobin A1c values checked if not 
performed in the three months prior to stroke onset and all patients to have 
fasting blood glucose to screen for diabetes. We expect hemoglobin A1c values 
to be checked if the patient does not have a diabetes diagnosis but has at least 
two fasting serum glucose values > 140mg/dl. 
Lifestyle counseling/referral made. VISTA/CPRS (for veterans) and INPC 
(Methodist and Wishard patients) data will be pulled to search for evidence of 
lifestyle counseling and/or referrals made to appropriate specialists and existing 
facility programs in physical activity (e.g. use of rehabilitation facility to exercise), 
diet (e.g. nutrition clinic; dietitian), weight management (e.g. MOVE program), 
smoking cessation (e.g. classes), GRACE, Telehealth, and patient education 
during the study period including FY10 to FY18. Data will be scored 
dichotomously as yes/no. Raters (research study staff) in Indianapolis and 
Chicago will be trained to abstract these chart data and a random sample of 
charts will be dually-reviewed to assess ongoing inter-rater reliability as we have 
previously done. We expect the majority of stroke survivors to receive counseling 
and/or referrals to specialists in physical activity and diet, two modifiable stroke 
risk factors. For those who are overweight or smoke, we will calculate the 
proportion that received counseling/referral to program. 
 
In addition to pulling data from VISTA/CPRS and INPC for all enrolled study 
participants, data from FY10 to FY18 for the Veteran Affairs study 
participants would be pulled electronically from the Corporate Data 
Warehouse VINCI and Austin National VA data. These data include vital 
signs, orders, consults, labs, health factors, fee-basis data, inpatient and 
outpatient files and vital status. 
We will use the Corporate Data Warehouse VINCI secure environment and 
the study folder on the Indianapolis VAMC HSR&D Research server, which 
is behind the VA firewall, for the abstracted data storage and analysis. The 
Indianapolis VAMC HSR&D Research server is behind the VA firewall and 
access is limited to approved individuals. Access to the server and study 
folder is controlled by VA username. 
 
Provider-Based Outcomes. Defining guideline-adherent treatment: We will determine 
medication management for stroke prevention treatment at the time of stroke discharge 
and at 3 and 6 months as a dichotomous yes/no variable using methodology developed 
in other VA studies and guided by a standard list of medications advocated in the stroke 
risk factor management program. The key stroke risk factors of interest are: 1) 
hypertension, 2) diabetes, 3) hypercholesterolemia. All of these outcomes will use the 
affected subgroup as the denominator and those on treatment as the numerator (e.g. 
subjects on treatment for hypertension/all subjects with a diagnosis of hypertension). 
Comparison will be by risk factor group. We expect all subjects to be discharged on 
either an antiplatelet (antithrombotics) or anticoagulant medication for stroke prevention, 
except in rare instances of contraindication (e.g. recent gastrointestinal or intracerebral 
hemorrhage, planned procedure in the next seven days) and so will assess this 
proportion treated out of all eligible patients. In addition, we will specifically examine the 
proportion of patients with atrial fibrillation and stroke who are appropriately 

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anticoagulated. In a similar method, the proportion of stroke survivors on statins, and 
antihypertensive medications will be assessed. In all treated patients, we will determine 
two key aspects of guideline adherence based on previously published methods in 
veterans:  
• 
dosage adequacy (# of tablets x strength (mg) of tablet/# days of prescription);  
• 
duration adequacy (# of days without medication/# days in the prescribing period 
after stroke) with inadequacy defined as > 21% of days without medication;  
We will use PBM data from FY10 to FY18 to determine adherent stroke risk reduction 
treatment prescribed pre-stroke and post-stroke. This would include outpatient 
medications. PBM variables include: Dosing instructions; Days Supply of Medication; 
Fill/Refill/Partial Date; Generic Drug Name; New/Refill/Partial Indicator; Patient ID(SSN); 
Prescription Patient Status; Provider Class; Provider Service/Section; Provider Specialty; 
Provider Subspecialty; Release Date; Total Quantity Dispensed; VA Drug Class; VA 
Product Name. The following are the precise VA Drug class data from the 
PharmacyBenefits Management Services (PBM) that would be used or reviewed.  
Anti-hypertensives/ 
statins 
 
CV100 
Beta blockers/related 
CV150 
Alpha blockers/related 
CV200 
CV250 
Calcium channel blockers 
Antianginals 
CV300 
Antiarrhythmics 
CV350 
Antilipemic agents 
CV400 
Anti-hypertensive combinations 
CV490 
Anti-hypertensives, other 
CV800 
Ace inhibitors 
CV805 
Angiotensin II inhibitor 
CV806 
Direct renin inhibitor 
CV900 
Cardiovascular agents, other 
Diuretics 
 
CV700 
Diuretics 
CV701 
Thiazides/related diuretics 
CV702 
Loop diuretics 
CV703 
Carbonic anhydrase inhibitor diuretics 
CV704 
Potassium sparing/combinations diuretics 
CV709 
Diuretics, other 
Diabetic medications 
 
HS500 
Blood Glucose regulation agents 
HS501 
Insulin 
HS502 
Oral hypoglycemic agents, oral 
HS503 
Antihypoglycemics 
HS509 
Hypoglycemic agents, other 
Thrombolytics 
 
 
tPA, tissue plasminogen activator 
 
anticoagulants 
 
antiplatelets 
Smoking Cessation Aides 
 

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6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
 
Per IU IRB protocol, all adverse events will be reported by the project 
coordinator/Care Manager to the IRB, VA R and D committee and VA research 
compliance officer within the required reporting time frame in which to submit.  
Adverse Events or unanticipated problems involving risk to subjects or other will 
be reported at the time of DSMB reviews. 
 
If participants experience chest pain, shortness of breath, or dizziness, while 
doing self management activities, they will be instructed to cease activity and see 
their physician immediately, if these symptoms persist or recur with further 
activity. The support and exit focus group meetings will be held at the Roudebush 
and Jesse Brown VAMCs, Wishard Hospital and/or Methodist Hospital, where 
access to emergency care is available 24 hours per day. All personnel will be 
trained in assessment and triage of symptoms post-stroke, and Ms. Nicholas has 
been successfully managing patients in this setting under the supervision of Drs. 
Williams and Damush during the past ten years.  
 
7.0 
Study Withdrawal/Discontinuation 
Any participant is permitted to withdraw from the project at any time without 
adverse effects.  Participants from Wishard hospital, Methodist hospital and 
Roudebush VAMC may withdraw from the study by notifying any of the 
Indianapolis research study staff.  If a participant withdraws, we will complete a 
standardized form for detailing the reason.  At the time participants withdraw, 
they will be informed that data already collected on them prior to the withdrawal, 
may continue to be reviewed by the study team, but further data collection will 
not occur. 
 
8.0 
Statistical Considerations 
 Planned Statistical Analyses                                                                                     
Baseline and Preliminary Analysis: In the randomized study, the preliminary 
phase of the analysis will consist of tabulating baseline characteristics of the 
participants who enrolled in the randomized study (from the survey and CPRS).  
The summary statistics will be compared between patients who were ineligible by 
provider review, eligible participants and eligible non-participants to see if the 
intervention reached a specific group of stroke survivors. We will use 
independent samples t-tests (for continuous measures) or chi-square tests (for 
categorical variables) to assess whether the randomization achieved balanced 
groups between sites. Power Estimation: Our primary endpoint is 12 months 
measurement with a 6-month intervention. With almost double dose of 
intervention, we expect that the intervention effect at 6-month may be larger than 
the 3-month intervention for SSQoL (overall score, family, and social roles), self-
management behavior frequency (minutes spent in aerobic, communication with 

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physician), and self-efficacy (communication with physician). Taking into 
consideration of the imbalance baseline measurements between two groups in 
the pilot study, a two group comparison of change may not appropriately reflect 
the real intervention effect. We therefore derive the change before and after the 
treatment in the intervention group from the pilot study and assume no change in 
control group as the basis of our sample size. We assume conservatively that the 
continued improvement of each individual in the second half the proposed study 
is only ¼ of the change in the first half, i.e. the proposed intervention will have 
only 1.25 times the effect of that in the pilot study. We expect the intervention 
effect at 12 months will be similar to the effect at 6 months. We performed the 
power calculation for the primary outcome SSQoL (overall, family, and social 
role) and secondary outcomes: Self-Management Behavior Frequency (minutes 
spent in aerobic), Self-efficacy (communication with physician), and Six-minute 
walk test. All the sample size calculations assumed an 80% power and 5% Type 
I error. 
9.0 
SSQoL: The primary hypothesis is participants randomly assigned to the 
intervention group will have a larger improvement of SSQoL overall score 
at the end of follow up (12 months) compared to those randomly assigned 
to the usual care group. Our pilot study demonstrated that overall SSQoL 
score in the intervention group increased by 0.2 with a SD<0.8. Assuming 
that in the stronger intervention of 6-month the improvement is 1.25 times 
of that of the pilot study and no change in the control group, the changes 
difference of overall SSQoL score will be 0.25. To achieve 80% power 
with 5% Type I error, we will need 162 subjects completing the 12 months 
follow up in each arm.   
10.0 Our pilot study showed that SSQoL family role score in the intervention 
group increased 0.5 with a SD=1.2. Assuming a 1.25 times change, the 
change difference of SSQoL family role score will be 0.75. Forty-nine 
subjects completing the 12 months follow up are needed in each arm to 
achieve 80% power to detect an effect on family role functioning. For 
treatment effect of SSQoL social role at 12-month, if we have 162 subjects 
completing 12 months follow up in each arm, we will have 80% power 
detecting an effect size of 31% of one standard deviation. In our pilot 
study, the effect size based on intervention arm is 21.4%. The detectable 
effect size is as small as 1.5 times of the pilot study. 
11.0 Self-Management Behavior Frequency: Our pilot study showed that 
minutes spent in aerobics  in the intervention group increased by 47.6 in 
the intervention group with a SD=126. Assuming 1.25 times of change in 
the stronger intervention, the change difference of minutes spent in 
aerobics will be 58.55. Seventy-four evaluable subjects completing the 12 
months follow up are needed in each arm to achieve 80% power to detect 
an effect on minutes spent on aerobics.  
12.0 Self-efficacy (communication with physician): Our pilot study showed 
that communication with physician in the intervention group increased by 
0.6 point in the intervention group with a SD=1.7. Assuming 1.25 times of 
change in the stronger intervention, the change difference of minutes 

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spent in aerobics will be 0.75. Eighty-two subjects completing 12 months 
follow up are needed in each arm to reach 80% power. 
13.0 Six-minute walk test: In a randomized trial (Marsden et al 2010) with a 
similar intervention, the intervention’s group improvement at 3 months was 
a distance of 16.1 meters with 35.1standard deviation. Assuming a similar 
difference and standard deviation in improvement, we will need Seventy-
six subjects per arm to reach 80% power. On the other hand, if we have 
113 subjects in each arm completing the 12 months follow up, we will be 
able to detect of a difference of 13.5 meters in change of the walk test 
between the two arms with more than 80% power.  
14.0 The largest sample size needed for our primary and secondary outcomes 
is 162 subjects per arm for SSQol overall score. Assuming a conservative 
25% dropout rate based on previous research, 216 subjects in each arm 
are needed at randomization. For the Six-minute walk, with 113 patients in 
each arm, we will be able to detect a difference of 30% standard deviation 
between the intervention and control group. 
15.0 Baseline analysis. Site and patient characteristics including patient age, 
gender, and outcome measurements (e.g., NIH stroke scale score, 
SSQoL scores, Self-efficacy) will be compared between the control and 
intervention arm and among the three sites. For continuous outcome 
variables, two-sample t-tests will be used for comparison between arms 
and analysis of variance (ANOVA) model will be used for comparison 
among sites. Chi-square tests will be used for comparison of categorical 
variables at baseline. Appropriate transformation for continuous variable 
will be used if there is a normality assumption violation. Wilcoxon’s rank 
sum test will be used if necessary. For all analysis, we will use Statistical 
Analysis Software (SAS, version 9.1, Cary NC).  
16.0 Primary analysis: Primary Aim 1. To determine the effect of a stroke self-
management program on stroke specific functioning and quality of life at 3, 
6, and 12 months. 
17.0 Comparison: The primary outcome in this study is SSQoL scores. The 
primary endpoints will be at 3, 6, and 12 months after randomization. We 
will first compare the 3-month, 6-month, 12-month, changes in overall 
SSQoL score between intervention and control groups using two-sample t 
test.  We will also graphically examine the time course of the effects, 
testing the change from baseline for each time point.  
18.0  Modeling:  We will fit linear mixed effect models for utilizing the repeated 
measurements of change of overall SSQoL score 3, 6, and, 12  months 
from baseline. Fixed and random effect covariates will be included. We will 
use time as a categorical predictor and include intervention and their 
interaction as factor. A positive significant interaction term indicates a 
larger improvement in the intervention group. Other fixed effects include: 
site, admission diagnosis (TIA/stroke), patients’ age, gender, baseline 
overall SSQoL score, and PHQ9 depression score. A random intercept will 
be included to accommodate the correlation among repeated 
measurement of SSQoL from the same subject. We will use unstructured 

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covariance matrix to model the within subject correlation. The study is 
powered to test the difference of change of overall SSQoL score. 
Similarly, we will apply these analyses to the SSQoL domains. We will add 
time since stroke event at baseline as a model covariate to control for this 
time effect. 
19.0 Missing Data: Patients baseline characteristics will be compared between 
those with and without missing outcome data. The primary analysis based 
on linear mixed model approach is used in many randomized clinical 
studies (e.g. SCAMP Trial by Dr. Kroenke, Bair, Damush et  al: JAMA; 
2009; 301(20):2099-2110) and is valid even with differential dropout rates 
as long as the missing-at-random assumption is not violated, i.e. the 
probability of missing is not dependent on the unobserved values. 
Although this assumption cannot be tested directly, we will first compare 
patients’ baseline characteristics will be compared between those with and 
without missing outcome data to assess potential nonrandom dropouts. 
We will also fit a logistic regression model to compare intervention and 
control subjects with missing outcome data to determine if there is biased 
dropout. These will be followed by a number of sensitivity analyses. First, 
missing outcomes will be imputed using the last-observation-carried-
forward (LOCF) method. Second, we will impute missing data using 
predicted values from linear models build on the observed data. Finally, 
multiple imputation techniques will be used to rerun the mixed model. If 
the various methods do not substantially change our findings on the main 
outcome, then the findings are robust. Otherwise, they will be interpreted 
with extreme caution. 
20.0 Secondary analysis: Secondary Aim 2. To determine the effect of a stroke 
self-management program on self-management process factors: self-
efficacy and self-management behaviors at 3, 6, and 12 months.   
21.0 The analytical technique in the primary outcome analysis will be similarly 
applied to our secondary outcomes which are continuous measurements 
including: the self-management behaviors and self-efficacy scores, and 
the Rankin scale. The change of six-minute walking distance from 
baseline to 3, 6, and 12-months will be compared using a two-sample t 
test.   
22.0 Summative Evaluation of Participants Barriers and Facilitators:  Aim 3. To 
gather insights during the exit focus groups from those who participated in 
the intervention program.  The method of analysis of exit focus group 
transcriptions is as follows:     
At least two investigators will independently review and code transcripts 
by assigning labels and codes to data segments. Drs. Damush, Schmid 
and Williams have previously coded and analyzed transcripts together. 
We will permit emerging themes to be coded in a bottoms-up manner as 
we have done previously. We will use the session notes to catalog the 
principal themes that ensued and issues of both consensus and difference 
that transpired. The field notes and audiotapes will be transcribed into 
computerized text. The first step in the analysis will be to create a set of 

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agreed upon codes and a codebook that serve as a template for coding of 
the data. The investigators will use an iterative consensus building 
process to generate codes.  Each investigator, working independently will 
highlight sections of the field notes and transcripts that illustrate a theme. 
In the margin of the notes or transcript they will write down the name of 
the theme.  In a subsequent meeting the investigators will compare notes, 
note agreements and attempt to resolve disagreements.  Once agreement 
on the themes has been reached they will be arranged in terms of content 
and scope.  The codes will be arranged in a "hierarchical" structure where 
each major category of codes contains subcategories within it.  The 
codebook will allow us to convert the group conversations into a formal set 
of categories that will be systematically applied to each transcript.  Once 
the coding is complete, we will generate reports and frequency counts of 
key themes including how often and where they occur.  The key task in 
this stage of the analysis is to make comparisons among the different 
categories of participants in the full sample. The goal is to detect patterns 
within each dataset that characterize potentially meaningful differences or 
similarities between groups. When we are not identifying new themes 
across the group’s text, we will have reached information saturation.   
Quotes will be grouped according to our major themes, including common 
and useful facilitators of stroke self-management behaviors, and barriers 
to such activity. Suggestions for improvements will be recorded. 
Frequency of themes will be analyzed first by identifying themes per 
question, then overall. We will construct a typology and describe findings 
using quotes to illustrate points. Analyses will include words, contexts, 
consistencies, frequencies, intensities, specificity, and finally, big overall 
barriers and facilitators of stroke risk factor management from the groups 
will be identified. Lifestyle and medication management needs and 
preferences will be identified. Moreover, we will solicit feedback on the 
delivery methods of the program and suggestions for improvement. 
 
         
9.0      Privacy/Confidentiality Issues 
 
To minimize risk of loss of confidentiality or privacy, our study team will 
implement several measures. The study research team in Indianapolis has 
extensive experience collecting and managing confidential research information.  
All study staff will be certified in human subject research training and will adhere 
to HIPAA and all VA standards for research study data privacy.  Study data will 
only be shared with approved study team members identified as having access 
to study data. Face to face interviews and self management sessions will be 
conducted in a private location at Methodist, Wishard, Jesse Brown VAMC, and 
Roudebush VAMC. Phone interviews and phone self management sessions will 
be completed at telephone number provided by the participant. Study staff will 
make these phone calls to participants from a private location within the study 
sites.  All subject interviews will be assigned a study ID number and all identifying 
information removed.   All paper files will be stored separately in locked file 

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cabinets only accessible to research staff and all electronic files will be placed on 
on a Roudebush VAMC server that is protected by the VA firewall. End of study 
subject focus groups will be audio recorded.  These audio recorded focus group 
sessions will be uploaded to a Roudebush VA study folder located on a secure 
server behind the VA firewall.  Uploaded audio recordings will then be 
immediately deleted from the recording device. The focus group audio recordings 
will be transcribed.  Transcribed and audio recorded data will be stored 
separately in locked file cabinets only accessible to research staff and/or on a 
computer that is password protected only accessible to research study staff at 
Roudebush VAMC.  Transcription will be performed using Microsoft Word by a 
VA approved/contracted service and stored on a password protected research 
servers that are protected by the VA firewall.  Participants will not be individually 
identified in any reports or manuscripts from the study data.   
Data transfers:  
Completed survey data for enrolled subjects will be sent via registered delivery 
service (i.e., UPS) from Jesse Brown VAMC in Chicago to Roudebush VAMC in 
Indianapolis, where the Indianapolis research staff will enter the data into the 
ACCESS database.  
 Methodist and Wishard retrospective patient data will be extracted by data 
management from the Regenstrief Institute, Inc which is part of a hospital 
medical records system that is linked city-wide in Indianapolis excluding the 
Roudebush VAMC. Specifically, Regenstrief data managers will look for primary 
discharge diagnosis ICD-9 codes related to ischemic stroke and TIA of Methodist 
and Wishard patients. The data managers will extract data (patient name, SSN, 
date of discharge) and load this data onto a VA issued USB thumb drive. This 
thumb drive will be password protected and hand delivered to our project 
coordinator at Roudebush VAMC on a quarterly basis. Regenstrief data 
managers may also transfer Methodist hospital and Wishard hospital stroke/TIA 
patient data to Roudebush VAMC electronically to a secure VA network drive 
using “slashtemp”. The Regenstrief retrospective data of Methodist and Wishard 
patients will be uploaded behind the Roudebush VA firewall and merged with the 
existing study data in a study file on a VA secure server, the “R” drive.  
 
10.0 
Follow-up and Record Retention 
All data collected with identifiers will be stored at the Roudebush VAMC 
indefinitely or until RCS 10-1 signifies a destruction timeframe of research 
records.  At the time of identifiable data discard, paper will be shredded, files 
from computers and audio devices will be permanently deleted, and CDs will be 
deleted and destroyed.