Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities: the SUCCEED Trial
Phase: NA
Conditions: Stroke, Secondary Stroke Prevention
Sponsor: University of California, Los Angeles

FULL PROTOCOL TITLE:  
Secondary stroke prevention by Uniting Community and Chronic care model teams 
Early to End Disparities:  the SUCCEED Trial 
NCT01763203
Supported by: 
The National Institute of Neurological 
Disorders and Stroke (NINDS) 
RFA-NS-12-007: Stroke Prevention/Intervention Research Program (SPIRP) (U54)
As submitted to NIH with grant application
April 2, 2012 

2 
Vickrey, Barbara G. (Project I) 
SUCCEED Trial 
04/02/12 
TABLE OF CONTENTS 
Page 
SYNOPSIS ................................................................................................................................................... 4 
1.
STUDY OBJECTIVES ...................................................................................................................... 6 
1.1 
Primary Objective ........................................................................................................................ 6 
1.2 
Secondary Objectives ................................................................................................................. 6 
2.
   BACKGROUND ............................................................................................................................... 7 
2.1 
Rationale ..................................................................................................................................... 7 
2.2 
Supporting Data .......................................................................................................................... 8 
3.
   STUDY DESIGN ............................................................................................................................... 9 
4.
   SELECTION AND ENROLLMENT OF SUBJECTS ....................................................................... 10 
4.1 
Inclusion Criteria ....................................................................................................................... 10 
4.2 
Exclusion Criteria ...................................................................................................................... 10 
4.3 
Study Enrollment Procedures .................................................................................................... 11 
5.
   STUDY INTERVENTIONS .............................................................................................................. 14 
5.1 
Interventions, Administration, and Duration ............................................................................... 14 
5.2 
Handling of Study Interventions .................................................................................................  14 
5.3 
Concomitant Interventions ......................................................................................................... 14 
5.4 
Adherence Assessment ............................................................................................................ 14 
6.
   CLINICAL AND LABORATORY EVALUATIONS .......................................................................... 15 
6.1 
Schedule of Evaluations ............................................................................................................ 16 
6.2 
Timing of Evaluations ................................................................................................................ 17 
6.3 
Special Instructions and Definitions of Evaluations .................................................................... 17 
7.
    MANAGEMENT OF ADVERSE EXPERIENCES ........................................................................... 20 
8.
    CRITERIA FOR INTERVENTION DISCONTINUATION ................................................................ 21 
9.
    STATISTICAL CONSIDERATIONS .............................................................................................. 22 
9.1 
General Design Issues .............................................................................................................. 22 
9.2 
Outcomes .................................................................................................................................. 22 
9.3 
Sample Size and Accrual .......................................................................................................... 22 
9.4 
Data Monitoring ......................................................................................................................... 23 
9.5 
Data Analyses ........................................................................................................................... 23 
10.
DATA COLLECTION, SITE MONITORING, AND ADVERSE EXPERIENCE
  REPORTING ............................................................................................................................... 24 

3 
Vickrey, Barbara G. (Project I) 
SUCCEED Trial 
04/02/12 
10.1 
Records to be Kept.................................................................................................................... 24 
10.2 
Role of Data Management......................................................................................................... 24 
10.3 
Quality Assurance ..................................................................................................................... 25 
10.4 
Adverse Experience Reporting .................................................................................................. 25 
11.
  HUMAN SUBJECTS ................................................................................................................... 26 
11.1 
Institutional Review Board (IRB) Review and Informed Consent ............................................... 26 
11.2 
Subject Confidentiality ............................................................................................................... 26 
11.3 
Study Modification/Discontinuation ............................................................................................ 26 
12.
  PUBLICATION OF RESEARCH FINDINGS ................................................................................ 27 
13.
  REFERENCES ............................................................................................................................ 28 

4 
Vickrey, Barbara G. (Project I) 
SUCCEED Trial 
04/02/12 
Target analytic sample of 
500 subjects in SUCCEED RCT
Patient meets inclusion criteria:
•
Stroke or TIA in the past 90 days
•
> 40 years of age
•
SBP >120 mm Hg
•
Speaks English, Spanish, Korean, Chinese
Baseline Data Collection:  Interview, BP measurement, lipid level
12 Month Data Collection: Interview, BP measurement, lipid level
Patient consents to 
participate in study
RANDOMIZATION 
(1:1, stratified by site and preferred spoken language)
3 Month Data Collection: Interview, BP measurement, lipid level
8 Month Data Collection: Interview
SYNOPSIS 
Study Title 
Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities:  
the SUCCEED Trial 
Objectives 
The primary objectives of this study are as follows: 
(1) To develop a community-centered component of a Chronic Care Model-based secondary stroke
prevention intervention.
(2) To test the impact of a sustainable Chronic Care Model-based intervention on control of systolic blood
pressure (primary outcome), composite stroke risk, and each individual stroke risk factor (secondary
outcomes), among 500 adults (over 90% minority) recruited “early” - during or shortly after
hospitalization for an ischemic or hemorrhagic stroke or TIA - at one of the four Los Angeles County
safety net medical centers.
(3) To conduct a cost analysis of SUCCEED from the perspective of the Los Angeles County Department
of Health Services, using intervention costs, cost equivalents of associated utilization of county system
resources, and cost equivalents of observed and projected vascular events.
Design and Outcomes  
The study design is a multi-center, randomized controlled trial. Patients will be randomized to either a Care 
Management and Community Health Worker led intervention versus Usual Care to improve management of 
stroke risk factors. The outcomes of this study will be assessed by a blinded Research Assistant. The total 
planned enrollment of this trail is 500 subjects. Subjects will be enrolled in the RCT for a period of 1 Year.  
Figure 1. SUCCEED Study Design 
We designate systolic blood pressure as the primary outcome for the 
purpose of sample size calculations.  We will assess multiple relevant 
outcomes including all risk factors and a composite index, cost, quality 
of life, adverse consequences, moderators, mediators, and a range of 
metrics of intervention program implementation and participation.   
Table 1 below shows the primary and secondary outcomes for 
SUCCEED. 
Table 1. Primary & Secondary Outcomes 
Primary Outcome 
Blood Pressure 
Secondary Outcomes 
Risk of recurrent stroke, future cardiovascular event 
Lipid profile: LDL cholesterol level, Triglyceride level, HDL cholesterol 
level 
Hemoglobin A1c 
C-reactive protein (CRP)
Adiposity: Body mass index (BMI), waist circumference, Waist-hip ratio, 
Waist-to-Height Ratio 
Healthy Lifestyle Behaviors & Factors: Physical Activity, Diet, Smoking, 
Alcohol Use 
Death 
Interventions and Duration 
We will test the impact of this multi-level, multi-component intervention relative to usual care within the Los 
Angeles County public safety net healthcare system to improve management of stroke risk factors and 
increase adoption of healthy lifestyle habits.  We will use culturally-adapted educational materials developed by 

  
community-academic partnering teams in our Public Outreach and Dissemination Core.  The on study period 
is 12 months. Additional follow-up off intervention will be every 6 months, up to 18 additional months during 
the period of center funding.  
Data sources include: 
•
Examinations (Blood pressure, height and weight, waist and hip circumference, NIHSS for
stroke severity, Rankin for disability): baseline, 3 months, and 12 months
•
Fingerstick laboratory tests (lipid profile, Hgb A1c, CRP) baseline, 3 months, and 12 months
•
Full survey: baseline, 3 months, 12 months
•
Telephone survey: 8 months
•
Telephone surveillance for vascular events and mortality: every 6 months, starting at 12 months,
continuing for duration of center funding
Queries of the Los Angeles county administrative database will be conducted when the study is 
completed for LAC service and medication utilization. 
Sample Size and Population  
The setting of this study is all four county hospitals that anchor care for patients in the Los Angeles County 
public healthcare system (LAC), which serves the largest, most ethnically diverse county in the United States.  
This system, often called the Safety Net, serves more than 10 million residents and provides healthcare to 
700,000 people every year, and treats more than 300,000 emergency and trauma victims every year. Through 
an integrated network of hospitals, health centers and clinics, the LA County Health Services System makes 
medical and preventive care services accessible in communities across the county. According to LAC 
administrative databases, more than 50% of patients use a language other than English as their primary 
language and 63% of outpatients are uninsured. 
A total of 500 subjects with the onset of ischemic stroke, hemorrhagic stroke, or transient ischemic 
attack (TIA) within the prior three months will be recruited from the following off-campus locations:  
•
(1) Los Angeles County Hospital + USC Medical Center (LAC+USC),
•
(2) Rancho Los Amigos National Rehabilitation Center (Rancho Los Amigos),
•
(3) Olive View-UCLA, and
•
(4) Harbor-UCLA Medical Center.
No subjects will be recruited at UCLA.  
Stratification variables are as follows, with 24 strata: 
•
Site (4 sites)
•
Language (3: English, Spanish, other)
•
Type of Stroke (2: ischemic/TIA, hemorrhagic)

6 
1 
STUDY OBJECTIVES 
1.1. 
Primary Objectives 
Primary Objective #1: To develop a community-centered component of a Chronic Care Model-based 
secondary stroke prevention intervention. This new component includes community health workers (CHWs) 
collaborating with healthcare system teams based at one of four Los Angeles County-Department of Health 
Services public “safety net” medical centers. CHWs - identified from the communities in which they serve - will 
receive specialized training and will conduct home visits to promote behavior change to address diet and 
physical activity risk factors, as well as assess for depression and social isolation. CHWs will use an existing, 
scalable mobile health platform specifically designed for care coordination and care teams to use by phone or 
iPAD, to assist patients in tracking selected clinical measures (blood pressure, lipids, weight/BMI, physical 
activity), to promote behavior change. CHWs will communicate and liaison with the healthcare provider team. 
The community-based component will also include cultural- and stroke-specific adaptation of physical activity 
and self-management programs at local community venues including health education and senior centers.     
Hypothesis: We will develop a culturally-tailored intervention to improve stroke risk factor reduction. 
Primary Objective #2: To test the impact of a sustainable Chronic Care Model-based intervention on control 
of systolic blood pressure (primary outcome), composite stroke risk, and each individual stroke risk factor 
(secondary outcomes), among 500 adults (over 90% minority) recruited “early” - during or shortly after 
hospitalization for an ischemic or hemorrhagic stroke or TIA - at one of the four Los Angeles County safety net 
medical centers. We will conduct a randomized trial of this intervention that includes the new, community-
centered component developed in aim #1, and a “re-engineered” healthcare delivery system with nurse 
practitioners or physician assistants as care managers, distribution of home blood pressure monitors, group 
clinics, and a care management software system tailored to secondary stroke prevention and interfaced with 
the mobile health platform used by the CHWs, relative to usual care.  We will include non-English speaking 
individuals from Hispanic, Chinese, and Korean racial and ethnic groups, and a broad range of stroke severity.  
We will analyze potential moderators (age, gender, stroke type and severity, education, country of birth/primary 
language, diabetes comorbidity, care team composition) to understand robustness of intervention impacts 
across levels of individual and health system characteristics. We will conduct a formative evaluation to 
continuously improve implementation, and will measure and analyze extent of intervention implementation, as 
it is delivered for up to 12 months after stroke or TIA through transition of patients into primary care.  We will 
analyze potential mediators (life chaos, competing needs, medication adherence, knowledge of stroke risk 
factors, participation in self-management programs, social isolation, depression, health literacy, engagement 
with healthcare provider team, attitudes/health beliefs, self-efficacy, readiness to change, perceived risk, and 
perceptions of quality of interactions with provider) of the intervention’s impact, using both qualitative and 
quantitative methods.   
Hypothesis: Patients randomized to the SUCCEED intervention will achieve 8mm greater reduction in systolic 
blood pressure reduction and lower stroke risk scores at 1 year versus those randomized to usual care.  
Primary Objective #3:  
To conduct a cost analysis of SUCCEED from the perspective of the Los Angeles County Department of 
Health Services, using intervention costs, cost equivalents of associated utilization of county system resources, 
and cost equivalents of observed and projected vascular events.  We will also develop a financial plan and 
proposal for sustainability of the intervention if it is effective, incorporating data on cost and utilization, to 
describe potential financial arrangements or approaches – including reimbursement strategies - to support the 
intervention model in the future and in other settings.  We will also produce training materials and protocols for 
future dissemination. 
Hypothesis: If effective, the SUCCEED intervention will be sustainable because its community component was 
developed in partnership with the community and is culturally-appropriate, it will demonstrate a projected cost-
offset from future vascular events averted, and intervention tools and training programs will be codified.   
1.2  
Secondary Objectives 
Not applicable 

7 
2 
BACKGROUND 
2.1 
Rationale 
Stroke is the fourth leading cause of death and the leading cause of adult disability in the United States, with 
well-documented and substantial disparities in the prevention and outcomes of stroke for blacks, Hispanics, 
and Asians relative to whites. The strongest predictor of a future stroke is a prior stroke or transient ischemic 
attack (TIA). Although the risk of stroke can be substantially reduced through control of modifiable risk factors 
including hypertension, diet, physical activity, and smoking, and through optimal management of diabetes and 
dyslipidemia there is abundant evidence that these risk factors are under optimal control in only a small 
proportion of stroke survivors, exposing hundreds of thousands of individuals each year to preventable death 
and disability from subsequent strokes. The situation is even more pressing among indigent, minority 
populations, in which knowledge about stroke is limited and barriers to accessing healthcare – transportation, 
healthcare-related costs, screening of phone communication due to concerns about immigration authorities,  
bill collectors, inability of healthcare providers to maintain current phone numbers due to patients use of 
prepaid phones that run out, beliefs about causes of stroke symptoms, unhealthy diets, lack of safe places to 
walk or local stores with fresh produce, homelessness, and many others - are formidable. Our group previously 
documented gaps in prevention care after stroke and analyzed barriers among the large, multi-ethnic indigent 
population in Los Angeles County, where out of the entire county’s approximately 10 million residents spread 
over several thousand square miles, fewer than 30% are non-Hispanic whites.  
Based on International Classification Codes (ICD) codes generated from the Los Angeles county Department 
of Health Services (LAC-DHC) database, there are over 1000 admissions of stroke per year at the four County 
anchor hospitals.  This eligible population is more than 20% greater than in SUSTAIN due to the inclusion of 
hemorrhagic stroke.  The eligibility is further increased by including more languages spoken by subjects.   
Table 2.  Stroke and TIA patients hospitalized in Los Angeles County, 2009-2011 
Facility 
Year 
Stroke 
ICD: 433,434, 436 
TIA 
ICD:435 
Hemorrhagic Stroke 
ICD: 430, 431 
Total 
Harbor-UCLA Medical Center 
2009 
250 
65 
72 
387 
2010 
218 
58 
72 
348 
2011 
250 
57 
59 
366 
Olive View Medical Center 
2009 
124 
31 
7 
162 
2010 
178 
29 
8 
215 
2011 
131 
30 
4 
165 
Rancho Los Amigos 
2009 
148 
46 
11 
205 
2010 
166 
40 
12 
218 
2011 
143 
45 
18 
206 
LAC+USC 
2009 
192 
31 
98 
321 
2010 
192 
52 
119 
363 
2011 
184 
51 
116 
351 
All Los Angeles County Safety Net 
Hospital 
2009 
714 
173 
188 
1075 
2010 
754 
179 
211 
1144 
2011 
708 
183 
197 
1088 
In addition to this eligible inpatient pool, outpatients who have had the onset of with a recent history of stroke or 
TIA are also eligible.  Rancho Los Amigos is implementing a medical home model for uninsured patients with a 
recent stroke, so patients who were admitted elsewhere for their stroke can be fast-tracked to receive post-
discharge follow-up care at Rancho Los Amigos.   

8  
Starting in 2010, Los Angeles County has implemented an Emergency Medical System (EMS) routing policy.  
Patients with acute onset of stroke symptoms within three hours are diverted to stroke certified centers.  None 
of the four LAC hospitals have obtained this designation yet.  However, we do not anticipate this to be a barrier 
to enrolling enough patients because the number of hospitalized stroke and TIA patients in 2011 remains 
above 1000.   
2.2 
Supporting Data (DR. CHENG will add SUSTAIN ABSTRACT you have until the end of this page) 
Our research team has designed and is implementing a chronic care model-based program called SUSTAIN 
(Systemic Use of STroke Averting INterventions) to improve the delivery of secondary stroke preventive 
services after hospital discharge.  This care intervention includes group clinics, self-management support, 
report cards, decision support through care guides and protocols, and coordination of ongoing care.  The first 
specific aim is to test via a randomized-controlled trial whether SUSTAIN improves blood pressure control 
among an analytic sample of 268 patients with a recent stroke or transient ischemic attack discharged from 
four Los Angeles County public hospitals.  Secondary outcomes consist of control of other stroke risk factors, 
lifestyle habits, medication adherence, patient perceptions of care quality, functional status, and quality of life.  
A second specific aim is to conduct a cost analysis of SUSTAIN from the perspective of the Los Angeles 
County Department of Health Services, using direct costs of the intervention, cost equivalents of associated 
utilization of county system resources, and cost equivalents of the observed and predicted averted vascular 
events.   
In this study, we build upon our experiences implementing SUSTAIN to enhance the access to community 
resources.  These include the use of community health workers, mobile technology to synchronize information 
while in the field, and increasing access to self-management classes.   

9 
3 
STUDY DESIGN 
Figure 1. SUCCEED Study Design 
The study design for SUCCEED trail is a multi-center, randomized 
controlled trial of a Care Management and Community Health 
Worker led intervention VS Usual Care to improve management of 
stroke risk factors. The outcomes of this study will be assessed by 
a blinded Research Assistant. Subjects will be enrolled in the RCT 
for a period of 1 Year.  A diagram of the study is provided as shown 
in Figure 1 to the left.  
We designate systolic blood pressure as the primary outcome for 
the purpose of sample size calculations.  We will assess multiple 
relevant outcomes including all risk factors and a composite index, 
cost, quality of life, adverse consequences, moderators, mediators, 
and a range of metrics of intervention program implementation and 
participation.  
Target analytic sample of 
500 subjects in SUCCEED RCT
Patient meets inclusion criteria:
•
Stroke or TIA in the past 90 days
•
> 40 years of age
•
SBP >120 mm Hg
•
Speaks English, Spanish, Korean, Chinese
Baseline Data Collection:  Interview, BP measurement, lipid level
12 Month Data Collection: Interview, BP measurement, lipid level
Patient consents to 
participate in study
RANDOMIZATION 
(1:1, stratified by site and preferred spoken language)
3 Month Data Collection: Interview, BP measurement, lipid level
8 Month Data Collection: Interview

10 
4 
SELECTION AND ENROLLMENT OF SUBJECTS 
The inclusion and exclusion criteria for the SUCCEED RCT are shown below: 
Table 3.  Inclusion and Exclusion Criteria of RCT 
Inclusion Criteria 
•
Patients of LAC + USC, Rancho Los Amigos, Olive View-UCLA, or Harbor-UCLA with
onset of ischemic stroke, hemorrhagic stroke, or TIA within the prior three months.
Exclusion Criteria 
•
Age < 40 years
•
SBP < 120 mm Hg
•
Speaks language other than English, Spanish, Korean, Mandarin, and Cantonese
•
Cannot provide informed consent due to dementia or aphasia
4.1 
Inclusion Criteria 
4.1.1 The disease or disorder under study, and how it is being documented (diagnostic methods, criteria for 
evaluation) 
Patients with onset of ischemic stroke, hemorrhagic stroke, TIA within the prior three months will be 
included in SUCCEED. Diagnosis is confirmed by referring clinician.  
4.1.2 Clinical indicators of currents status, as measured with XX days of randomization. 
Not applicable 
4.1.3 Prior therapy, if any. Consider listing prior treatments. Consider listing the allowable duration for the 
specific population to be studied (treatment-naïve, treatment-experienced, or prior-treatment-failed 
“salvage subjects”) 
Not applicable 
4.1.4 Demographic characteristics 
Patients over 40 years of age will be included in SUCCEED. Patients will be included if they speak 
English, Spanish, Korean, Mandarin, or Cantonese.  
4.2 
Exclusion Criteria 
4.2.1 List any clinical contradictions. Specify grades of signs/symptoms 
Persons with language (aphasia) or cognitive difficulties are ineligible if they cannot communicate that 
they understand the study during the informed consent process.   
4.2.2 Clinical/laboratory indicators of current status, obtained within XX prior to randomization. List the 
specific tests to be performed and the narrowest acceptable range of laboratory values for exclusion, 
consistent for safety.  
Systolic Blood pressure > 120 mmHg 
4.2.3 Specify any exclusion related to pregnancy, lactation, or plans to become pregnant. Specify methods 
for assessing current status and willingness to use contraception, if applicable. 
Not applicable 
4.2.4 Use of excluded drugs, devices, etc. within XX days prior to entry 
Not applicable 

11 
4.2.5 For drug studies: Allergy/sensitivity to study drugs or their formulations 
Not applicable 
4.2.6 Specify any clinical (life expectancy, co-existing disease), demographic (age) or other characteristics 
that precludes appropriate diagnosis, treatment, or follow-up in the trail 
Young patients are excluded because the mechanism for their strokes is frequently not due to 
atherosclerosis (e.g. arterial dissections, congenital coagulation defects, etc), so the interventions in 
this proposal may not be as applicable to them.  We will also exclude persons who already meet the 
primary outcome of SBP <120 mm Hg.  We will not be able to translate written materials in languages 
other than English, Spanish, Korean, and Chinese. Patients who do not speak any of those languages 
will be excluded. 
4.2.7 Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere 
with adherence to the study requirements. 
If the participant exhibited active drug or alcohol use or dependence that, in the opinion of the site 
investigator would interfere with adherence to study requirements, that participant would be excluded 
from the study.  
4.2.8 Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes 
therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least XX prior to 
the study. (List specific illnesses and acceptable time) 
Not applicable, hospitalized patients are being enrolled in the study. 
4.2.9 Inability or unwillingness of subject to give written consent. 
If a subject is unwilling to give written consent, they will be excluded from the trial. Persons with 
language (aphasia) or cognitive difficulties are ineligible if they cannot communicate that they 
understand the study during the informed consent process.   
4.3 
Study Enrollment Procedures 
4.3.1 Methods for identifying and recruiting candidates for the trial 
The research team will present SUCCEED to clinicians in the neurology, internal medicine, family 
medicine, emergency department, and the rehabilitation departments.  Study flyers will be posted on 
the wards, outpatient clinics and housestaff offices of these departments.  In the inpatient setting, we 
will discuss the study with neurology ward nurses and discharge planners, and they will include study 
flyers in discharge packet.  In the outpatient setting, we will discuss the study with the clinic 
coordinators.  Housestaff will be given pocket-sized index cards about the trial.  One side of the index 
card contains a short description of the aim and the eligibility requirements.  The back side of the index 
card contains an IRB-approved short script of a few sentences that describe the study and ask for 
verbal permission for a member of the research team to approach them to further discuss the study.  
Finally, contact information of the research team is listed on the card.   
We will adapt our highly successful protocol utilized in the SUSTAIN study to identify, approach, and 
recruit subjects for the SUCCEED study.  As stated earlier, a potential subject’s clinician need to obtain 
verbal permission from them before passing their name to a member of the research team.   
In the inpatient setting, we have found that embedding the RA within the inpatient team during rounds 
fosters awareness about the study and prompts the study team during rounds to verbally ask patients 
for permission for the RA to meet the patient later.   

12  
           
In the outpatient setting, clinicians would notify the site PI, who attends the clinic.  The Site PI then 
contacts the research team RA. Because outpatients may need to leave the clinic immediately after 
the  visit with the clinician, the RA may not be able to speak to outpatients before they leave, but they 
will be enabled to call the patient at a later time.   
Alternatively, potential subjects can also directly call the RA using the toll-free number listed on flyers to 
learn more about the RCT.   
4.3.2 Procedures (e.g., maintaining a screening log at each clinical site) for documenting how subjects 
learned about the trial, who referred them to the trial, reasons for ineligibility, and reasons for 
nonparticipation of eligible subjects.  
Please refer to section 4.3.3 for procedures on consent, documenting how subjects learned about the 
trial, who referred them to the trial, reasons for ineligibility, documentation of ineligibility, and reasons 
for nonparticipation of eligible subjects. A description of how this information will be collected centrally 
and used to enhance subject recruitment efforts is also provided. 
4.3.3 Consent (and assent) procedures 
Interaction between the RA and the potential research subject 
•
Arranging initial meeting: When a clinician notifies the RA a face-to-face meeting will be arranged to
check whether the patient meets eligibility criteria for enrollment and to describe elements required
for informed consent.  The RA will read an IRB-approved script that further describes the
SUCCEED trial to the patient.
If a potential subject directly contacts the RA using the toll-free number, the RA will read the IRB-
approved script that further describes the SUCCEED trial to the patient.  If the potential subject is
interested, a face-to-face meeting will be scheduled.
•
Setting: The consent process will take place in a private room.  If the meeting takes place in a
shared hospital room, the research staff member will close the curtain when meeting with the
participant.  The RA will describe the study.  RA will be bilingual in English or Spanish, but in the
case that a subject speaks a language other than English or Spanish, the research team will use
volunteers fluent in the appropriate language to translate for the RA.
•
Eligibility: If interested in continuing, the RA will ask potential subjects questions about age, and
onset of stroke to confirm eligibility.  They will also take BP measurements.  Finally, they will ask
questions that require comprehending the basics details of the study.  If participants cannot
describe what is told to them, they will not be enrolled in SUCCEED.  For potential subjects found to
be ineligible, the reasons for ineligibility will be recorded.
•
Voluntary consent: The RA will ensure that eligible subjects are given every opportunity ask
questions, and remind the patients that participation in SUCCEED is voluntary.  If interested, the
potential subject will sign the written consent form. Potential participants will have the opportunity to
take the consent document home and discuss participation with others before making a decision.
•
Declining consent: If patients do not consent to the study, the RA will record the reason why the
patient did not consent. Further, the RA will ask permission to use the demographic information of
the patient to generate enrollment propensity weights.  Enrollment propensity weights will be used
to analyze how the tendency to participate in the RCT impacts attainment of outcomes.
•
Storing consent forms.  The consent forms at each site will be stored in a locked file cabinet within a
locked room.  Access is limited to the site’s Principal Investigator and research staff.

13 
For the baseline survey, the RA will enter the circumstances of the initial visit (inpatient/outpatient, 
whether clinical team called RA or subject, reasons for ineligibility, and reasons for nonparticipation).  
These data will be summarized in a monthly report by site and shared among the Task Force and the 
research teams at UCLA and at each site.   
4.3.4 Procedure for obtaining intervention group assignment 
Before the RCT begins, we will use computer-assisted stratified randomization of block size of 4.  The 
three stratification variables will be site, spoken language (Spanish, English or other), and type of 
stroke (ischemic or hemorrhagic).  These lists have an allocation ratio of 1:1 of control and intervention.  
Permuted block randomization that stratifies by site will be used to promote periodic balance through 
the trial and group balance at the end of the trial.  The study programmer/analyst will generate 24 lists, 
one for each stratum.  Each row of the list will include a unique subject IDs and intervention arm of the 
study.  The lists will be kept in a notebook that the Project Coordinator will possess at all times.   
For patients who consent to the study and meet inclusion criteria, the RA will collect baseline data 
(described below in section of Outcome Measures) before randomization so that the RA will collect data 
uniformly regardless of the eventual allocation of the subject.  After an eligible participant has 
consented and completed the baseline survey, the RA will inform the Project Coordinator with the 
information needed to choose which of the 24 lists to use.  The Project Coordinator will find the next 
uncrossed row, tell the RA the unique subject ID and intervention assignment, then cross out that row 
so that the next row will be used when this list is used again.   
The Project Coordinator will assign the newly enrolled participant a unique subject ID and inform the 
RA the assigned randomization status of this subject.  The Project Coordinator will mark down in the 
notebook the date of randomization for that subject ID.    
Efficiency and productivity metrics such as tracking the effectiveness and outcomes of recruitment 
strategies employed 
We have the data to determine the enrollment ratios.   
•
Numerator: we have developed tracking databases for the RAs to record the number of approached
patients per month.  They further document the reason for ineligibility among subjects.  For eligible
subjects, the RAs further document which patients consent or decline to participate, and for those
that decline, the reasons for not participating.
•
Denominator: On a periodic basis, administrators at the LAC-DHS run reports for the SUSTAIN
team that show the number of patients hospitalized at each site per month.
Using our tracking databases and the LAC-DHS reports, we can calculate the proportion of hospitalized 
stroke patients approached by our research team and the proportion of eligible stroke patients who 
consent to participate in the study.  This will allow us to discern when and where and why study 
enrollment rates are lower than expected.   
These enrollment statistics will be shared among the research team and the Task Force.  If rates of 
participating are lower than expected at a site, we will investigate the reasons for doing so and develop 
strategies for overcoming barriers.  This feedback loop has been critical for developing our successfully 
recruitment strategy in SUSTAIN.   

14 
5 
STUDY INTERVENTIONS 
5.1 
Interventions, Administration, and Duration 
The intervention team consists of the following: 
•
Care Managers
•
Community Health Workers
•
Research Assistants
The intervention is: 
•
Care by CM
•
Medical algorithms
•
Report cards
Community Health worker home visits and community self management classes, supported by mobile 
technology. 
5.2 
Handling of Study Interventions 
Not applicable 
5.3 
Concomitant Interventions 
5.3.1 Required Interventions 
Not applicable 
5.3.2 Prohibited Interventions 
Not applicable 
5.3.3 Precautionary Interventions 
Not applicable 
5.4 
Adherence Assessment 
For subjects randomized to the intervention arm, we will document the number of encounters between subjects 
and the intervention team.  This will include the number of face-to-face visits, number of telephone calls, 
number of classes attended, and the number of home visits.   

15 
6 
CLINICAL AND LABORATORY EVALUATIONS 
The Schedule of Evaluations in section 6.1 indicates all study evaluations. An ‘X’ in a cell indicates that a 
particular evaluation is to be performed at a particular study visit. 
The definitions for the Schedule of Evaluations are included in section 6.2 where evaluations are defined, 
timelines are provide, special considerations or instructions for evaluations are included. 

16 
6.1 
Schedule of Evaluations 
On-Intervention 
Off-Intervention 
Evaluation 
Screening/ 
Baseline 
3 
months 
8 
months 
12 
months 
18 
months 
24 
months 
30 
months 
Informed Consent 
X 
Physical Exam: Blood Pressure (BP), Body 
Mass Index (BMI), Waist-Hip Ratio, Waist-to-
Height Ratio, NIH Stroke Severity Scale, 
Modified Rankin Scale  
X 
X 
X 
X 
Finger Stick LDL (Triglyceride level, HDL cholesterol 
level, Hemoglobin A1c, C-reactive protein (CRP) 
X 
X 
X 
X 
Full In-Person Questionnaire 
X 
X 
X 
Brief Telephone Questionnaire 
X 
Telephone Surveillance (vascular events/death) 
X 
X 
X 

17 
6.2 
Timing of Evaluations 
6.2.1 Pre-Randomization Evaluations 
*Please note: All evaluations occur prior to the subject receiving any study interventions.
Screening, Entry Surveys, and Randomization 
Screening for inclusion/exclusion criteria, baseline (entry surveys), and randomization occur in the 
same face-to-face encounter.   
6.2.2 On-Study/On-Intervention Evaluations 
See Section 6.1 for the schedule of evaluations occurring after randomization while the subject is on-
study.  The allowable window for evaluations during the on-intervention period is one month around 
each timepoint.   
6.2.3 Intervention Discontinuation Evaluations 
If patients wish to withdrawal from the study prematurely, we will attempt to administer the final 
outcome measurement survey.  Additionally, the reason for discontinuation will be recorded.  
Retention of subjects will be enhanced by collecting multiple phone numbers and addresses for each 
subject and multiple phone numbers for a close friend and family member.   
6.2.4 On Study/Off-Intervention Evaluations 
The evaluation schedule remains the same while the subject is “off intervention/on study” for 
SUCCEED (see Section 6.1). 
6.2.5 Final On-Study Evaluations 
The schedule of activities during the final 12 month measurement time point is the same as the 
baseline and 3 month time points, with the difference being that there is no need to conduct the 
randomization procedures other than the baseline time points.   
After the study is completed, we will call the subjects every 6 months for up to 30 months after 
randomization to conduct surveillance of vascular events and ascertainment of mortality.   
6.2.6 Off-Study Requirements 
Once the subject has completed the protocol-specified period on study intervention, they will be follow-
up with every 6 months for up to 18 months for the occurrence of vascular events and death. Refer to 
Section 6.1. 
6.2.7  Pregnancy 
Women who become pregnant while on-study, will be instructed to continue their normal care. No 
additional evaluations are needed.  
6.3 
Special Instructions and Definitions of Evaluations 
6.3.1 Informed Consent 
The patient education and informed consent process has been detailed in Section 4.3.3. Further, plans 
review of consent document in case changes may be required and how documentation of signed 
consent will be maintained by the study are outlined in that section. 
A model informed consent form should has been included as Appendix.  When developing the consent 
form, consider including language allowing for the retention of study data and specimens beyond the 

18  
       
close of this study, for sharing the de-identified data and specimens with other researchers, and for 
using the specimens for purposes beyond the scope of this study. 
6.3.2 Documentation of [specify the Disease/Disorder under study] 
We will review administrative databases to determine if the patient has suffered a stroke, myocardial 
infarction, and death during the study period. 
6.3.3 Medical History 
Self report in a survey. We will review administrative databases to determine if the patient has suffered 
a stroke, myocardial infarction, and death during the study period.  
6.3.4 Treatment History 
Self report in a survey 
6.3.5 Concomitant Treatments 
Not applicable 
6.3.6 Study Intervention Modifications 
Not applicable 
6.3.7 Clinical Assessments 
Because NINDS strongly encourages investigators to make use of the NINDS Common Data Elements 
in developing the CRFs (see http://www.commondataelements.ninds.nih.gov/), the study team will rely 
on those materials in the development of CRFs for SUCCEED. 
Blood Pressure (BP): Participants are seated quietly for 5 minutes before Blood Pressure (BP) 
reading are initiated. Staff are trained to ensure that the proper cutoff size is used and that the 
participant’s arm is resting on a flat surface, with the BP cuff at heart level. Two sequential readings will 
be taken using the OMRON 90XL with 5 minute intervals between each reading. If the first two readings 
differ by more than 5mmHg, then an additional two readings are taken and recorded electronically 
using a laptop based data entry system developed through Core A. Average BP is calculated by the 
data collection system.  
NIHSS and disability scales: Each RA will obtain certification to perform the National Institute of 
Health Stroke Scale (NIHSS) and the modified Rankin scale prior to the start of the study.  These are 
measures of stroke severity and disability.  Certification is obtained by completing the following courses 
and taking a test by scoring an online video of a patient.   
http://nihss-english.trainingcampus.net/uas/modules/trees/windex.aspx and  
http://rankin-english.trainingcampus.net/uas/modules/trees/windex.aspx?res. 
In addition, the RA will be observed by the site PI for at least the first two study participants.  Each RA 
will be re-observed examining a study participant 2 months later, then 4 months later.   
6.3.8 Laboratory Evaluations 
LDL Cholesterol: Point-of-service CardioChek meters will be used to collect information on LDL 
cholesterol. The meters require only a small capillary blood sample (from a fingerprick). After cleaning 
the end of one finger with an alcohol wipe, a small lancet is used to prick the participant’s finger. The 
first blood spot is wiped off with gauze and the next blood spot is dropped into a special cartridge which 
is then simply inserted into the CardioCHek meter for the calculation of LDL cholesterol. Staff will 
record results electronically using the laptop-based data entry system.  

19  
  
Glycosylated Hemoglobic (HgA1c) and C-Reactive Protein (CRP): We will use dried blood spots 
(DBS) to obtain assays for these two parameters. Whatman 903 Protein Saver filter paper is used for 
DBS collection; this paper is commercially available as small cards. Participants should be well 
hydrated as this facilitates collection of adequate DBS. Staff are trained to ask about hydration and to 
provide some water if participant hasn’t had much to drink recently. Participants are asked to wash their 
hands with very warm water, to remove lotions, and to aid blood flow. To further aid in blood flow to the 
hand, participants can be asked to wrap their hand in a heating pad or two hold a heat pack and/or to 
hang their arm down and shake their hand downward/ Similar to the CardioChek protocol, the end of 
one finger is then cleaned with an alcohol wipe, a small lancet is used to prick the middle or ring finger 
on the fleshy side. The first blood spot is wiped off with gauze. The following blood spot is allowed to 
“pool” on the finger and then to drop onto the collection card. (Whatman cards have circles printed on 
the card so blood spots can be dropped to fill-in each circle) Cards will be labeled with each subject’s 
study ID, along with information on date and time of collection. Once blood spots have been collected, 
cards are placed as “drying boxes” as they require air for at least 2 hours. With cards individually 
“housed” in separate boxes, staff can stack boxes of cards over the course of a day as they collect 
samples from participants. Once cards have dried at least 2 hours, they are to be placed in a storage 
envelope with a dessicant packet (all supplies provided through Core C) and then frozen. Samples 
collected for Project 1 at hospital settings will be stored in local freezers and transported weekly to Core 
C freezers on the UCLA campus.  
6.3.9 Pharmacokinetic Studies 
Not applicable 
6.3.10 Other Laboratory Studies 
Not applicable 
6.3.11 Additional Evaluations 
Not applicable 
6.3.12 Questionnaires 
Full in person Questionnaires:  
Demographics, Stroke knowledge/attitudes, Medication adherence (simony scale), Competing 
needs, Access to care, Chaos questions (Outreach questionnaire), Perception of Neurological 
care (CHAHPS), Patient Health Questionnaire (PHQ2), Social support items, Medical Utilization 
items (including hospital and physicians visits and other medical services), RAND SF-6D 
Brief Telephone Questionnaire: 
Medication adherence (simony scale), Medical Utilization items (including hospital and 
physicians visits and other medical services) 
6.3.13 Adherence Assessments 
For subjects randomized to the intervention arm, we will document the number of encounters between 
subjects and the intervention team.  This will include the number of face-to-face visits, number of 
telephone calls, number of classes attended, and the number of home visits.   

20 
7 
MANAGEMENT OF ADVERSE EXPERIENCES 
•
Elder Abuse: Under California law, all healthcare employees are mandated to report elder abuse.  If abuse
is suspected during your encounter with the patient, the site PI will be contacted.
•
Elevated Blood Pressure: If the subject experiences elevated blood pressure that meets the following
criteria, the following steps should be taken:
o
If ≥ 140 – verbally inform the subject that their BP is at least 140 and give a card to the subject with
the reading.
o
If ≥ 180 – inform the subject that they must see their doctor immediately. If the subject does not
have a primary doctor, the patient must go to the emergency room.
•
Suicide:  Although the subject will not be asked specific questions regarding suicidality, if the subject
expresses suicidal ideation or states they are thinking about harming themselves or have recently
attempted to do so, the site PI will be contacted.

21 
8 
CRITERIA FOR INTERVENTION DISCONTINUATION 
If a patient has optimal control of all risk factors, the criteria for discontinuing intervention are met, but that 
participant will still remain a part of the study.   

22 
9 
STATISTICAL CONSIDERATIONS 
9.1 
General Design Issues 
The primary and secondary hypotheses is that subjects randomized to the intervention arm will have better 
control of risk factors and higher rates of adoption of healthy lifestyle habits compared to the control arm.   
All outcomes will be collected by a blinded RA.  Vascular events will be collected by patient self-report and will 
not require an adjudication committee.   
The design is a RCT, 1:1 allocation to control and intervention arms.  There is no crossover. 
Randomization is stratified by site (4), language (3: English, Spanish, other), and type of stroke (2: 
ischemic/TIA, hemorrhagic).  There are 24 strata.    
Intervention on period is up to 12 months for persons.  It may be discontinued if subjects optimally control risk 
factors.   
After the 12 month study period, subjects will be monitored by telephone for the presence of vascular events 
and mortality.  There is no face-to-face contact, and thus, no collection of SBP, the primary endpoint.  This 
surveillance is to better determine the impact of the intervention in the first 12 months after randomization.   
9.2 
Outcomes 
9.2.1 Primary outcome 
Refer to Table 1 provided below. 
9.2.2 Secondary outcomes 
Refer to Table 1 provided below. 
Table 1. Primary & Secondary Outcomes 
Primary Outcome 
Blood Pressure (change in blood pressure, as well as proportion of patients with BP under 120/80) 
Secondary Outcomes 
Risk of recurrent stroke, future cardiovascular event 
Lipid profile: LDL cholesterol level, Triglyceride level, HDL cholesterol level 
Hemoglobin A1c 
C-reactive protein (CRP)
Adiposity: Body mass index (BMI), waist circumference, Waist-hip ratio, Waist-to-Height Ratio 
Healthy Lifestyle Behaviors & Factors: Physical Activity, Diet, Smoking, Alcohol Use 
Death 
9.3 
Sample Size and Accrual 
Power Analysis 
Power Analyses was conducted with comparison of main outcomes (systolic blood pressure (SBP)) between 
the control and intervention arms. Based on availability of patients and our capacity, we plan to enroll 500 
subjects from four senior centers. Using Intra-class correlation (ICC) of the four centers at 0.0085 level, attrition 
after the baseline  between 20% to 30% level, mean SBP 141 mm Hg and standard deviation (SD) 20, three 
repeated measurements: baseline, 3 months, and 12 months (Brown and Prescott 2006), the underlying 

23  
  
statistical power of the study comes from two dimensions of observations: the number of unique subjects and 
the number of repeated measurements within a subject. Based on sample size and power analyses method 
proposed by Diggle et al. (1994) and Liu et al. (2005) for repeated measures analysis with a type I error of 
0.05, type II error of 0.2 (or equivalent to power of 80%),  2.6 and 2.4 average data points for each subject 
(corresponding to 20% and 30% attrition respectively), and an auto-correlation at 0.2 level, the effective 
sample size will be 147 and 147 out of the planned 250 and 250 participants in each of the 2 arms (after 
adjusting for clustering effect), which will enable us to detect an effect size for SBP as small as 0.215 in 
standard deviation units or 4.29 mm Hg (for 20% attrition), and 0.253 in standard deviation units or 5.06 mm 
Hg (for 30% attrition).  
The seminal work for moderator and mediator effect was from Baron and Kenny (1986). For potential 
moderators (e.g., age, gender, stroke type and severity, education, country of birth/primary language), we will 
test power of moderation using the most common measure of effect size f2 (Aiken & West, 2001), which equals 
the unique variance explained by the interaction term divided by sum of the error and interaction variances. 
Cohen (1988) has suggested that f2 effect sizes of 0.02, 0.15, and 0.35 are termed small, medium, and large, 
respectively. A more realistic standard for effect sizes with moderators might be 0.005, 0.01, and 0.025 for 
small, medium, and large, respectively.   
Due to the low power in tests of moderation, there are greater interests in mediation over moderation 
(McClelland & Judd, 1993). To analyze power of potential mediators (e.g., self-efficacy, self-management, 
social isolation, depression, perceived risk of stroke), we will use indirect effect, which is the product of 
coefficient from independent variable to mediator, and mediator to the outcome. Because an indirect effect is a 
product of two effects, the usual Cohen (1988) standards of .1 for small, .3 for medium, and .5 values should 
be squared. Thus, a small effect size would be .01, medium would .09, and large would be .25 (or we can use 
small .02, medium .15, and large .40.)  
The effect size for SBP as small as 0.215 in standard deviation units or 4.29 mm Hg (for 20% attrition), and 
0.253 in standard deviation units or 5.06 mm Hg (for 30% attrition) can be considered clinically meaningful in 
the present of both moderators and mediators. Thus, the planned sample size should be sufficient for 
analyses. 
9.4 
Data Monitoring 
For Care Management studies such as this proposed study, a Data Safety Monitoring Board (DSMB) is not 
usually required. However, should NINDS require a DSMB, we will establish an Internal DSMB for this minimal 
risk study. Care coordinators will be monitoring risk factor control and resource utilization of subjects 
randomized to the intervention.  Care coordinators will be making multiple telephone calls about coordination of 
care.  They will ask subjects about the steps they are taking to lower the risk of stroke.   
ClinicalTrials.gov Requirements 
This trial does not meet the FDAAA requirement for mandated registration in ClinicalTrials.gov because it does 
not involve a drug, biologic, or device.  However, we do plan to register this trial on ClinicalTrials.gov.  Such 
registration is required for findings to be published in many medical journals, and it could also serve to 
enhance the dissemination of the trial’s results.  
9.5 
Data Analyses 
Baseline characteristics between the SUCCEED intervention and usual care groups will be compared. 
Continuous variable means will be compared using the t-test and ordinal or non Gaussian continuous variables 
will be compared using the Wilcoxon rank sum test. Unordered categorical variables will be compared using 
Chi-square test or Fisher’s exact test.  

24  
   
Enrollment weights based on a logistic regression model will be calculated using demographic data collected 
from eligible non-participants.  If needed, attrition weights will be determined from logistic regression models 
using demographic data on participants who drop out of the study.  These two weights will be combined to 
form an overall weight (using the inverse of the product of the probabilities of participation).  Both raw and 
adjusted rates using the overall weight will be compared between SUCCEED and usual care arms.   
Intention to treat analyses on all primary and secondary outcomes will be conducted using ordinal logistic or 
multiple linear regression models, incorporating the overall weight.  Intervention status will be an independent 
variable in all models.  We will compare study outcomes between the control and intervention groups both with 
and without adjusting for potential covariates associated with the outcome measure.   
We will test the moderator and mediator effects separately. To assess the moderating effects, we will compare 
regression models we fit including interaction terms between the independent variables and each possible 
effect modifier, and the models that do not include the corresponding interaction terms, using the likelihood 
ratio test (LRT). To assess the mediating effects, we will use Baron and Kenny (1986) methods to run a series 
of regression analysis and use the Sobel test and Bootstrapping to test mediating effects. 
To check the fidelity (uptake) of the SUCCEED intervention, we will also analyze attendance at SUCCEED 
clinics and the number of telephone coordination of care calls made during enrollment.   
Because subjects will be recruited from four hospital systems, there could be some underlying intra-site 
correlations of outcome measures in the collected data, which will have potential impacts on statistical 
significant tests of parameter estimates in the analyses. To take this into account in our analyses and 
modeling, robust standard errors will be calculated using Huber/ White/Sandwich method to ensure valid 
significance testing.  Although we will assess for the impact of clustering data structure, we do not expect a 
large intra-site correlation because the three sites are part of the same county healthcare system and we are 
not aware of differences of outcomes by site. Furthermore, we will also include site dummies in our model to 
control and evaluate the differences in parameter estimates, especially if there are significant variations among 
the sites.     
10 
DATA COLLECTION, SITE MONITORING, AND ADVERSE EXPERIENCE REPORTING 
10.1 
Records to Be Kept 
Linking file 
Each of the four sites will maintain a linking file that includes identifying information (name, address, 
phone number) and the subject ID. These files are for the purpose of subject tracking, and subject 
payment tracking. These files will be password-protected on a designated computer in a locked office 
and only site’s Principal Investigator and research staff will have access to the tracking file. Site’s 
tracking files will not be sent to UCLA. Only the site’s Principal Investigator and research staff will have 
access to the tracking files. Electronic files will be kept until the completion of all data collection and the 
successful creation of the final analytic dataset. 
10.2 
Role of Data Management 
10.2.1 Clinical site responsibilities in data collection and management 
The clinical site responsibilities are to perform the examination, laboratory tests, and the surveys on the 
subject. 
They will then enter the values directly into the web database of outcome measures.  The 
research team will enter a username and password to generate a blank form for entering 

25 
outcome data.  The RA will enter the subject ID and the measurements from the examination, 
survey, and laboratory procedures.  Once the data is submitted, the data is not retrievable on 
the internet, but only to the research team at UCLA.  After the data is entered, it is longer 
available to persons at the site.  It will only be accessible at UCLA, the Statistical Center for the 
study.   
10.2.2 Statistical Center responsibilities in data management 
The Statistical Center will analyze the data stored on a UCLA server. No identifiers that will be kept with 
the data, so it is considered anonymous.   
10.3 
Quality Assurance 
The central research team at UCLA will periodically conduct site visits to ensure quality assurance, and to 
check if evaluations are collected appropriately. Additionally, the data will be reviewed periodically by the 
central research team at UCLA to audit data for completeness.  
10.4 
Adverse Experience Reporting 
Adverse experiences will be reported as required by the IRB at each site.  There are no additional FDA 
regulations because we are not studying a biological agent.  The Manual of Operations will include detailed 
definitions of adverse experiences, a table for grading their severity, and details of how clinical sites are to 
report them.  

26 
11 
HUMAN SUBJECTS 
11.1 
Institutional Review Board (IRB) Review and Informed Consent 
This protocol and the informed consent document (Appendix I) and any subsequent modifications will be 
reviewed and approved by the IRB or ethics committee responsible for oversight of the study.  A signed 
consent form will be obtained from the subject. The consent form describes the purpose of the study, the 
procedures to be followed, and the risks and benefits of participation.  A copy of the consent form will be given 
to the subject, and this fact will be documented in the subject’s record. 
11.2 
Subject Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records that leave the site will be identified only 
by the Study Identification Number (SID) to maintain subject confidentiality.  All records will be kept in a locked 
file cabinet.  All computer entry and networking programs will be done using SIDs only.  Clinical information will 
not be released without written permission of the subject, except as necessary for monitoring by IRB, the FDA, 
the NINDS, the OHRP, the sponsor, or the sponsor’s designee. HIPAA guidelines for confidentiality and the 
principles of medical ethics will be adhered to during the study.  
11.3 
Study Modification/Discontinuation 
The study may be modified or discontinued at any time by the IRB, the NINDS, the OHRP, or other 
government agencies as part of their duties to ensure that research subjects are protected. 
The NIH, and local IRBs have the authority to stop or suspend this trial at any time. This study may be 
suspended or closed if: 
•
Accrual has been met
•
The study objectives have been met
•
The Study Chair / Study Investigators believe it is not safe for the study to continue
•
The NIH or FDA suspends or closes the trial

27 
12 
PUBLICATION OF RESEARCH FINDINGS 
Publication of the results of this trial will be governed by the policies and procedures developed by the 
Executive Committee. Any presentation, abstract, or manuscript will be made available for review by the 
sponsor and the NINDS prior to submission. 

28 
13 
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