Improving Quality of Life for Veterans With Stroke and Psychological Distress
Phase: NA
Conditions: Stroke, Depression, Anxiety
Sponsor: VA Office of Research and Development

 
 
  
Cover Sheet 
Document date 9/22/2023 
NCT03645759 
ID:D2898P     Improving Quality of Life for Veterans With Stroke and Psychological 
Distress 
  
     
 
 
 
 
 
 
 

 
Institutional Review Board for Baylor College of Medicine and Affiliated 
Hospitals 
  
Protocol Number:    H-43730 
Status:                        Approved 
Initial Submit Date:  9/20/2018 
Approval Period:       8/9/2021 - 8/8/2026 
  
Section Aa:  Title & PI 
A1.  Main Title 
    IMPROVING QUALITY OF LIFE FOR VETERANS WITH STROKE AND PSYCHOLOGICAL DISTRESS 
A2.  Principal Investigator 
  
    Name:   
GINA EVANS 
Phone:   
713-851-9482 
    Id:   
157378 
Fax:   
    Department:   PSYCHIATRY & BEHAVIORAL SCIENCES 
Email:    
ginae@bcm.tmc.edu
    Center:   
Mail Stn:   BCM350 
 
A3.  Administrative Contact 
  
    Name: 
KATHERINE ELLANE GARRETT 
Phone:   
713-440-4400 
    Id:   
195238 
Fax:   
713-748-7359 
    
Email:    
kegarret@bcm.tmc.edu
    
Mail Stn:   BCM288 
A3a.  Financial Conflict of Interest 
Does any member of study personnel (Investigator (including investigator's spouse and/or dependent children)) that 
are involved in the design, conduct, or reporting of the research have a Significant Financial Interest (SFI) that 
would reasonably appear to be affected by the research for which funding is sought and/or associated with an 
entity/business that would reasonably appear to be affected by the research? 
        No 
  
Section Ab:  General Information     
A4.  Co-Investigators 
  
    Name:   
BARBARA KIMMEL 
Phone:   
713 7986361 
Id:   
130394 
Fax:   
Department:   NEUROLOGY 
Email:    
bkimmel@bcm.edu
Center:   
Mail Stn:   BCM609 
 
  
    Name:   
JANE ANDERSON 
Phone:   
713-794-7393 
Id:   
145197 
Fax:   
Department:   NEUROLOGY 
Email:    
janea@bcm.tmc.edu
Center:   
Mail Stn:   BCM609 
 
  
    Name:   
SHUBHADA SANSGIRY 
Phone:   
713-794-8601 
Id:   
162834 
Fax:   
713-748-7359 
Department:   MEDICINE: HEALTH SRVCS RESEARCH 
Email:    
sansgiry@bcm.tmc.edu
Center:   
Mail Stn:   BCM288 
  
    Name:   
HUBERTA "BETTE" COZART 
Phone:   
7138193137 
Id:   
178907 
Fax:   

Department:   PHYSICAL MEDICINE & REHABILITATION 
Email:    
cozart@bcm.edu 
Center:   
Mail Stn:   BCM310 
  
    Name:   
LINDSEY MARTIN 
Phone:   
713-794-4947 
Id:   
179624 
Fax:   
713-748-7359 
Department:   MEDICINE: HEALTH SRVCS RESEARCH 
Email:    
lindseym@bcm.tmc.edu
Center:   
Mail Stn:   BCM288 
  
    Name:   
DENNIS VILLAREAL 
Phone:   
713-794-7156 
Id:   
184416 
Fax:   
713-794-7771 
Department:   MEDICINE: ENDOCRINOLOGY 
Email:    
villarea@bcm.tmc.edu
Center:   
Mail Stn:   BCM185 
  
    Name:   
ANGELLE SANDER 
Phone:   
713-666-9550 
Id:   
994965 
Fax:   
713-383-5695 
Department:   PHYSICAL MEDICINE & REHABILITATION 
Email:    
asander@bcm.tmc.edu
Center:   
Mail Stn:   TIRR 
  
    Name:   
BILLIE BOWMAN 
Phone:   
Id:   
Non-Baylor 
Fax:   
Institution:   
Michael E. DeBakey VA Medical Center 
Email:    
Billie.andrews@va.gov
Address:   
Houston,TX 
A5.  Funding Source: 
    Organization:  VA CENTRAL OFFICE, RR&D 
A6a.  Institution(s) where work will be performed: 
    Michael E. DeBakey Veterans Affairs Medical Center 
 
A6b.  Research conducted outside of the United States: 
    
Country:   
Facility/Institution:   
Contact/Investigator:   
Phone Number:   
If documentation of assurances has not been sent to the Office of Research, please explain: 
A7.  Research Category: 
    
A8. Therapeutic Intent 
Does this trial have therapeutic intent? 
    No 
  
A9. ClinicalTrials.gov Registration 
Does this protocol/trial require registration on ClinicalTrials.gov due to it: meeting the definition of an Applicable 
Clinical Trial, being required under the terms and conditions of an award, or being proposed to be published in 
ICMJE journals? 
    
No, this clinical is not a clinical trial, or does not meet the definition of an Applicable Clinical Trial, or does not 
need to be registered under the terms and conditions of an award, or is not a clinical trial with results intended to 
be reported in an journal belonging to the ICMJE. Registration is not required. 
  
Section B:  Exempt Request 
B.  Exempt From IRB Review 
    Not Applicable
  

Section C:  Background Information 
    
Veterans with stroke often experience comorbid psychological distress (i.e., depression and anxiety). A recent 
meta-analysis and systematic review indicates depression is present in 33%, and anxiety is present in 24%, of 
patients with recent stroke. Untreated or poorly managed psychological distress decreases stroke outcomes for 
physical functioning (PF), social role functioning (SRF) and quality of life (QoL). PF is often characterized as 
engagement in activities of daily living (i.e. bathing and grooming) whereas SRF refers to participation in valued 
social roles, including employee, student, family member, friend, teammate, etc. Impairments in PF and SRF are 
associated with poor QoL poststroke. 
Stroke self-management treatment can improve disability, confidence in recovery, and QOL. Veterans with 
comorbid stroke and psychological distress have suboptimal outcomes. They are less adherent to PF and 
physical activity self-management behaviors that promote mobility and experience social isolation; limit 
interactions with family, friends and community members; and disconnect from social networks. Few self-
management treatments address or treat comorbid psychological distress. Enhanced behavioral self-
management programs addressing disease-specific self-management and psychological distress have 
evidenced positive physical, social and QoL outcomes in Veterans with similar neurological conditions. There 
has yet to be such a treatment for Veterans with stroke and psychological distress. The Co -I, Dr. Anderson, 
developed the Self-management TO Prevent Stroke using Video teleconferencing (VSTOP-II) intervention that 
decreases behaviors that are risk factors for stroke and improves stroke health outcomes. The PI, Dr. Evans, 
developed a cognitive-behavioral treatment that targets healthy eating and physical activity health behaviors and 
psychological distress management, Enhancing Psychological Distress Coping (EPiC), which demonstrated 
improvements in psychological distress and QoL. The 2 programs will be combined to develop a single, 
behavioral stroke self-management treatment that addresses both stroke risk reduction and psychological 
distress. The intervention is intended to help Veterans practice health behaviors that reduce risk of a second 
stroke and is titled "I'm Whole". 
  
Section D:  Purpose and Objectives 
    
The overall goal of this study is to develop, refine, and pilot the I¿m Whole treatment for Veterans with stroke 
and comorbid psychological distress. This project will also gather preliminary data on the effects of I¿m Whole 
on QoL, PF (activities of daily living and physical activity), SRF, psychological distress and satisfaction with I¿m 
Whole. 
  
Section E:  Protocol Risks/Subjects 
E1.  Risk Category 
    Category 1: Research not involving greater than minimum risk. 
E2.  Subjects 
Gender:
    Both 
Age: 
    Adult (18-64 yrs) 
 
Ethnicity: 
    All Ethnicities
Primary Language:
    English
  
Groups to be recruited will include: 
    Asymptomatic patients with chronic conditions, healthy 
Which if any of the following vulnerable populations will be recruited as subjects? 
    Mentally ill 
Vulnerable populations require special protections.  How will you obtain informed consent, protect subject 
confidentiality, and prevent undue coercion? 

    
We will recruit male and female Veterans with mild to moderate symptoms of anxiety and depression . 
Participants who have poorly controlled mental illness that prevent capacity to provide consent will be excluded 
from the study. Participants who are unable to provide informed consent or who demonstrate cognitive limitations 
as evidenced by a score of 3> on a cognitive screened will be excluded from the study. We will use the teach 
back method of ensuring the Veteran understands the purpose, procedures, benefits and risks of participation of 
the study to ensure they understand, are able to provide proper consent and to prevent any coercion. Veterans 
who are unable to successfully repeat back the study information will be excluded. We will also consent 
individuals after they have discharged from the hospital and have been back in their home setting to prev ent 
obtaining consent from anyone under duress associated with an acute care setting. 
 
E3.  Pregnant woman/fetus 
Will pregnant women and/or fetuses (as described in 45 CFR 46 Subpart B) be enrolled in the research?
    No 
E4.  Neonates 
Will neonates of uncertain viability or nonviable neonates (as described in 45 CFR 46 Subpart B) be enrolled in the 
research? 
    No 
 
E5.  Children 
Will children be enrolled in the research? 
    No 
  
Section F:  Design/Procedure 
F1.  Design 
Select one category that most adequately describes your research: 
    c) Pilot 
Discuss the research design including but not limited to such issues as: probability of group assignment, potential 
for subject to be randomized to placebo group, use of control subjects, etc. 
    
I¿m Whole is a 6 session behavioral treatment that addresses psychological distress and stroke self-
management behaviors that will be delivered via VT in the home. The treatment will be delivered weekly over 6 
weeks. One module will be provided each session. The sessions will last approximately 30-45 minutes.The first 
module will combine the VSTOP-II stroke self-management education regarding stroke risk factors and EPiC 
psychoeducation on how comorbid psychological distress can create barriers to engaging in stroke self-
management behaviors. Clinicians will work with each Veteran to establish individualized plans for psychological 
distress management and strategies for practicing tailored PF, physical activity and SRF behaviors in line with 
the Veteran¿s values. Progress towards the Veteran¿s tailored PF, physical activity and SRF behaviors will be 
reviewed, and psychological distress barriers will be discussed in future modules. Modules 2-5 will be electives 
that provide cognitive behavioral treatment (CBT) based behavioral activation, social -support, cognitive-
restructuring, thought-stopping, deep-breathing, and problem-solving skills for improving psychological distress-
related barriers to practicing established PF, physical activity and SRF behaviors. Module 6 consists of a relapse 
prevention plan for continued management of psychological distress. Homework and tracking logs will be 
provided at the end of each session. The Co-I, Dr. Villareal, will provide feedback during the development and 
refinement stages regarding creating tailored PF and physical activity strategies for participants. The Co-I, Dr. 
Sander, will provide feedback in the development and refinement stages regarding client-centered strategies for 
reintegrating into family and community roles and activities poststroke. A clinician manual and pati ent workbook 
will be developed. 
In phase I: The PI will work with the study team to combine the EPIC and VSTOP treatments into one cohesive 
treatment called IM WHOLE. No Veterans will be involved in this phase. 
In Phase II: The PI will pilot I¿m Whole by treating 5 Veterans suffering from stroke and comorbid psychological 
distress. Five Veterans with stroke and comorbid psychological distress will be recruited from the stroke acute 
care unit, rehabilitation unit, and outpatient stroke follow-up clinic. Qualitative interviews asking the Veterans 
opinion regarding the treatment content and delivery method will be administered at the end of the final session.
In phase III:Interested Veterans will be randomized to I¿m Whole (n=15) or usual care plus education  (UC+E) 
(n=15), respectively. Veterans in the UC+E group will receive standard acute care, rehabilitation unit or 

outpatient follow-up clinic stroke treatment provided at the MEDVAMC. The standard of care for these patients 
consists of appointments in the outpatient stroke follow-up clinic, medication management for comorbid chronic 
diseases, and general physical rehabilitation exercises. To account for additional treatment contact provided to 
participants in I¿m Whole, UC+E will also receive 6 brief teleph one calls with information regarding unrelated 
health topics (e.g., breast, colon, rectal, esophageal, skin and testicular cancer treatment and prevention). We 
will track the number of patients screened, number and percent of patients eligible, number rand omized, number 
and percent completing treatments, and number and percent completing subsequent follow-up assessments 
following treatment completion. Veterans in I¿m Whole will complete the same qualitative interviews described in 
phase II. 
 
Inclusion Criteria: 
    
Inclusion for Phase II and Phase III:1) a documented history of stroke and/or transient ischemic attack within the 
last 30 days, 2) a modified Rankin score of > 3, 3) regular access to a computer or tablet with internet and a 
camera, 4) ability to give appropriate informed consent, 5) score > 5 on a measure of depression (Patient Health 
Questionnaire [PHQ-8]) and/or >17 on a measure of anxiety (Generalized Anxiety Disorder-7 [GAD-7]) 
assessments, 6) ability to ambulate with or without assistance of a cane or walker. 
Exclusion Criteria: 
    
Exclusion Criteria for Phase II and Phase III: 1) cognitive impairment, as evidenced by a score of >3 on a brief 
cognitive screener; 2) documented diagnosis of psychotic disorder or schizophrenia; 3) documented severe 
depression, anxiety (based on PHQ-8 or GAD-7 score of > 20), or hospitalization for psychiatric illness within the 
past 30 days. 
F2.  Procedure 
    
Phase I: The PI will merge stroke self-management and psychological distress treatment modules from their 
established EPiC and VSTOP-II programs. The first module will combine the VSTOP-II stroke self-management 
education regarding stroke risk factors and EPiC psychoeducation on how comorbid psychological distress can 
create barriers to engaging in stroke self-management behaviors. Clinicians will work with each Veteran to 
establish individualized plans for psychological distress management and strategies for practicing tailored PF, 
physical activity and SRF behaviors in line with the Veteran¿s values. Progress towards the Veteran¿s tailored 
PF, physical activity and SRF behaviors will be reviewed, and psychological distress barriers will be discussed in 
future modules. Modules 2-5 will be electives that provide CBT-based behavioral activation, social-support, 
cognitive-restructuring, thought-stopping, deep-breathing, and problem-solving skills for improving psychological 
distress-related barriers to practicing established PF, physical activity and SRF behaviors. Module 6 consists of a 
relapse prevention plan for continued management of psychological distress. Homework and tracking logs will be 
provided at the end of each session. Dr. Villareal will provide feedback during the development and refinement 
stages regarding creating tailored PF and physical activity strategies for participants. Dr. Sander will provide 
feedback in the development and refinement stages regarding client-centered strategies for reintegrating into 
family and community roles and activities poststroke. The treatment will consist of 6 sessions over 6 weeks and 
will be delivered to Veterans in their homes, using VT technology. A clinician manual and patient workbook will 
be developed. There will be no Veteran involvement at this phase. 
In Phase II: The PI will pilot I¿m Whole by treating 5 Veterans suffering from stroke and comorbid psychological 
distress. Five Veterans with stroke and comorbid psychological distress will be recruited from the stroke acute 
care unit, rehabilitation unit, and outpatient stroke follow-up clinic. The participants will receive each of the I'm 
Whole sessions using VT in the home. Sessions will be delivered weekly over 6 weeks. Clinicians will work with 
the Veteran to establish goals in the first session that will be reviewed through the remaining sessions. 
Qualitative interviews asking the Veterans opinion regarding the treatment content and delivery method will be 
administered at the end of the final session. 
The barriers to receiving the intervention via VT and acceptability of the intervention content and procedures will 
be assessed informally after each session, and responses will be reviewed at weekly team meetings to address 
any unanticipated results and make needed immediate changes to the intervention. A semi-structured interview 
will occur with each Veteran post-treatment, conducted by the RA trained by Co-I Martin, an expert in qualitative 
methods. Interviews will occur by phone and include open -ended questions regarding recruitment; engagement 
and retention strategies; assessment procedures; participant burden; redundancy and length and frequency of 
treatment; effectiveness, usefulness of I¿m Whole content, and perceived benefits and barriers to receiving the 
sessions via VT to the Veteran¿s home. Detailed notes will be taken during interviews, which will also be audio 
recorded and transcribed for analysis. Rapid analysis is a systematic and rigorous process of condensing 
qualitative data to quickly identify key findings to inform study progress (i.e., refine and modify I¿m Whole 
content, delivery methods and treatment procedures). The information from the transcribed notes and feedback 
received in weekly meetings will be used to modify the IM WHOLE treatmen t. 

Phase II and Phase III: Screening and Recruitment Procedures. We will recruit men and women Veteran stroke 
patients of all races and ethnicities with depression and anxiety symptoms who are being treated in the stroke 
acute care inpatient unit, rehabilitation unit, or outpatient stroke follow-up clinic at the Michael E. DeBakey VA 
Medical Center (MEDVAMC). The MEDVAMC treats over 310 Veterans with stroke each year, of which 
approximately 93 (33%) have comorbid psychological distress. We have successfull y recruited Veteran stroke 
patients in our previous stroke studies. The research assistant (RA) will approach potential participants at 
bedside in the acute or rehabilitation unit or during the first follow-up visit after admission from the stroke acute 
care unit. Veterans interested in the study will be screened for eligibility via their electronic medical records 
(EMR) to see if they meet preliminary study inclusion/exclusion criteria (listed above). Those who meet the 
eligibility criteria will receive a follow up session. in their home or at the MEDVAMC to be administered the 
screening measurements listed above. If participants via EMR review or baseline assessments: 1) do not 
demonstrate or show evidenced of a cognitive impairment, as evidenced by a score of >3 on a brief cognitive 
screener; 2) have a documented diagnosis of psychotic disorder or schizophrenia; 3) score in the severe range 
for depression, or anxiety (based on PHQ-8 or GAD-7 score of > 20), or have a documented or self-reported 
hospitalization for psychiatric illness within the past 30 days, they will be invited to participate in the study. They 
will be provided instructions regarding using VTEL to conduct their sessions, given a I¿M WHOLE workbook and 
scheduled a time for first session with the study clinician. A note will be placed in the electronic medical records 
(EMR)s documenting the visit. Participants who do not meet the criteria will be immediately notified of their 
ineligibility. A note will be placed in the EMR documenting why they were not eligible. Their primary care provider 
will be signed to the note for follow up discussion regarding possible referrals or additional services needed for 
the Veteran. The Veteran will also be provided a list of community based psychiatric and med ical resources. 
Phase II and Phase III: Treatment Procedures and Development-- Sessions will be conducted by 1 clinician with 
master¿s-level training in health education, counseling or social work and expertise in CBT, psychological 
distress treatment, and/or chronic disease management. The clinician will conduct the sessions from the 
MEDVAMC using VA Video Connect VT to the Veterans in their homes. The MEDVAMC frequently uses VT for 
clinical treatment and research and has established VT programs and equip ment that is VHA approved and 
readily available. 
Assessment Procedures. Each participant in phase II and phase III will receive 20.00 for each assessment they 
complete (0/6/12 weeks). Assessments will be conducted by an Independent Evaluator (IE). We esti mate that 
each assessment will take about 30 to 40 minutes. If scores on the psychological distress measure worsen (e.g., 
20% or more increase), the PI will be notified and participants referred to mental health treatment within the 
MEDVAMC or the community. 
Phase III: This group will consist of the treatment (I'm Whole group) and usual care group will receive the 
standard of care. The standard of care for these patients consists of appointments in the outpatient stroke follow-
up clinic, medication management for comorbid chronic diseases, and general physical rehabilitation exercises. 
To account for additional treatment contact provided to participants in I¿m Whole, UC+E will also receive 6 brief 
telephone calls with information regarding unrelated health topics (e.g., breast, colon, rectal, esophageal, skin 
and testicular cancer treatment and prevention). 
  
Section G:  Sample Size/Data Analysis 
G1.  Sample Size 
How many subjects (or specimens, or charts) will be used in this study?
    Local: 50              Worldwide: 50 
Please indicate why you chose the sample size proposed: 
    
Phase I: does not involved participants. We plan to recruit 5 participants for phase II and 30 participants for 
phase III. To account for a 40% drop out rate the PI evidenced in a prior studying using Video telehealth, we will 
over recruit for phase II and phase III. Recruitment feasibility of approximately 6 subjects per month is based on 
the number of participants from Dr. Anderson¿s VSTOP study who also had comorbid psychological distress. 
The study is underpowered to show clinically meaningful efficacy of I¿m Whole when compared to usual care.
G2.  Data Analysis 
Provide a description of your plan for data analysis. State the types of comparisons you plan (e.g. comparison of 
means, comparison of proportions, regressions, analysis of variance). Which is the PRIMARY comparison/analysis? 
How will the analyses proposed relate to the primary purposes of your study? 

    
We hypothesize that, at 12 weeks posttreatment, Veterans randomized to I¿m Whole will show greater 
improvements in the primary outcome (QoL) and secondary outcomes (PF, physical activity, SRF and 
psychological distress). On the basis of retention rates for VSTOP trials using VT, we anticipate a 20% loss-to-
follow-up rate at 12 weeks post-treatment. Initial analyses will be intention-to-treat. Analyses will be repeated 
using the observed data (completer analyses). We will run linear regression models. The mo del for each 
outcome will include treatment, time (baseline, posttreatment, and 12 weeks post-treatment) and treatment-by-
time interaction. Significant interaction will indicate that the intervention groups showed differential improvement 
over time. We will use SAS PROC MI and PROC MIANALYZE to impute missing data and conduct analyses. 
Key demographic and clinical variables (e.g., age, gender, stroke, psychological symptom severity and 
psychotropic medication use) will be described for each group as recommended by the CONSORT statement for 
RCTs. We will calculate the effect size, d, at post-treatment and at 12 weeks posttreatment, using mean values 
from the estimated means and standard errors from the linear model analyses of the imputed datasets. 
  
Section H:  Potential Risks/Discomforts 
H1.  Potential Risks/Discomforts 
Describe and assess any potential risks/discomforts; (physical, psychological, social, legal, or other) and assess the 
likelihood and seriousness of such risks: 
    
The study will present minimal risks or discomforts. Participants will be asked if they have any psychological 
distress that may prevented them from fully participating in their stroke self-management treatment. Participants 
may become mildly uncomfortable with disclosing their psychological distress level and symptoms. However, 
participants will be reminded that they can discontinue their participation at any time if they feel uncomfortable or 
feel like their symptoms are getting worse as a result of the treatment. The PI is a licensed psychologist who is 
able to provide any additional support, symptom assessment, and/or referrals for psychological services that 
may be needed. 
H2.  Data and safety monitoring plan 
     Do the study activities impart greater than minimal risk to subjects?
        No 
H3.  Coordination of information among sites for multi-site research 
Is the BCM Principal Investigator acting as the SPONSOR-INVESTIGATOR for this multi-site research? 
        No or Not Applicable
Is BCM the COORDINATING CENTER for this multi-site research?
        No or Not Applicable
 
  
Section I:  Potential Benefits 
Describe potential benefit(s) to be gained by the individual subject as a result of participating in the planned work.
    
Participants can gain a better understanding of their barriers to healthy eating, physical activity, physical mobility, 
social engagement, and medication adherence . Understanding and implementing changes to overcome these 
barriers can lead to improved stroke self-management, decreased stroke risk and improve overall health 
outcomes. 
Describe potential benefit(s) to society of the planned work. 
    
Psychological distress is common among patients who have had a stroke. Increased psychological distress is a 
predictor of poor mobility and quality of life outcomes post stroke. Thus, it is essential to understand 
psychological distress barriers to healthy engagement in stroke self-management behaviors. This information 
should be used to incorporate psychological distress treatment into evidenced based stroke self-management 
interventions to improve health outcomes among persons at high risk for secondary stroke and related chronic 
disease. Successful findings can lead to the development and implementation of a comprehensive treatment that 
addresses stroke self-management and psychological distress concurrently. This can have widespread public 
health implications given the high prevalence rate of stroke and comorbid psychological distress. 
Stroke patients with co morbid mental illness have more outpatient visits and withdraw from family and 
community activities more due to psychological symptoms than stroke patients that are not suffering from 
comorbid mental illness. Better stroke management can lead to increased family and community involvement 
and over all quality of life as a result. 

Do anticipated benefits outweigh potential risks? Discuss the risk-to-benefit ratio. 
    Having a better understanding of psychological distress barriers to making healthy stroke self-management 
choices will have greater benefits and outweigh potential risks. 
  
Section J:  Consent Procedures 
J1.  Waiver of Consent 
Will any portion of this research require a waiver of consent and authorization?
    Yes 
Please describe the portion of the research for which a waiver is required. (Example: chart review to determine 
subject eligibility) 
    
A preliminary chart review will be conducted for interested study participants to examine if they have been 
hospitalized for psychiatric reasons within the last 30 days and if they have a diagnosis of psychotic or bipolar 
disorder to ensure study eligibility. A waiver of consent and HIPAA authorization is requested to determine 
subject eligibility. 
An additional waiver of HIPPA authorization is being requested for the entire study for the following reason: To 
reduce participant burden, verbal consent is being obtained for study participation (see request to waive written 
documentation of consent in J1a). Therefore, we request a waiver of the requirement for HIPPA authorization for 
study participation. 
Explain why the research and the use or disclosure of protected health information involves no more than minimal 
risk (including privacy risks) to the individuals. 
    
The research involves no more than minimal risk to the participants because the waiver will not affect the rights 
and welfare of the potential participants as this knowledge will be gained from medical records which can be 
accessed widely by VA researchers and clinicians. The only information reviewed in the medical records is that 
which will have already been asked of the patients. The patient will also be informed the research staff will 
review their medical records for the inclusion/exclusion criterial only. 
The examination will be limited to mental health diagnosis, coexisting medical conditions, hospitalization for 
psychiatric, substance and/or alcohol use within the last 30 days. This information would have already been 
shared with the patient. Also, the data will not be used for any clinical purposes but only to determine eligibility
for the current study. The purpose of collecting information covered under U.S.C 7332 is to conduct scientific 
research and no personnel involved in this study will identify, directly or indirectly, any individual patient or 
subject in any report of such research." 
Explain why the waiver will not adversely affect the privacy rights and the welfare of the research subjects. 
    
The waiver or alteration will not adversely affect the rights and welfare of the subjects, because the waiver will 
not affect the privacy rights and welfare of the potential participants as this knowledge will be gained from a 
medical records which can be accessed widely by VA researchers. The medical records information reviewed by 
the research staff that has already been shared with the patients and does not include undisclosed health 
information. The medical records examination will be limited to mental health diagnosis, coexisting medical 
conditions, hospitalization for psychiatric within the last 30 days. This information would have already been 
shared with the patient. Also, the data will not be used for any clinical purposes but only to determine elig ibility 
for the current study. 
Explain why the research could not practicably be conducted without the waiver and could not practicably be 
conducted without access to and use of the protected health information. 
    
The research could not practicably be carried out without the waiver or alteration and without access to and use 
of the requested information, because conducting this initial medical chart investigation is essential to the 
research project. After experiencing a stroke, Veterans can experience a varying level of psychologic al distress 
and may have pre-existing psychological distress. Our program is not suited for participants with severe 
psychological distress. It would not be feasible to rely solely use the statements of the participant to gauge 
inclusion and exclusion criteria given patients with prior psychological distress may be more focused on the 
physical aspects of their stroke rather than their prior psychological symptoms. A greater focus on their physical 
changes may impact accurate recall of past information. 
Describe how the research could not practicably be carried out without using the collected identifiable biospecimens 
in an identifiable format. 
    NA 

Describe how an adequate plan exists in order to protect identifiers from improper use and disclosure. 
    
An adequate plan exists in order to protect health information identifiers from improper use and disclosure, 
because all gathered PHI for potential participants will be stored in a locked file cabinet in a locked data storage 
room behind the VA firewall. No one outside of the PI, PI's research coordinator, Baylor College of Medicine 
Institutional Review Board members, VA Research and Development office and research compliance officers will 
have access to the data or limited PHI information. 
Describe how an adequate plan exists in order to destroy identifiers at the earliest opportunity consistent with 
conduct of the research, unless there is a health or research justification for retaining the identifiers or such 
retention is otherwise required by law. 
    
An adequate plan exists in order to destroy identifiers at the earliest opportunity consistent with conduct of the 
research (absent a health or research justification for retaining them or a legal requirement to do so), because 
the information will be de-identified during the data entry process. The de-identified information will be used 
during all statistical analysis. The de-identified data will be stored in an encrypted file on the VA server. All of the 
identifiable and de-identified data (VA consent and HIPPA forms and audio files) will be properly destroyed 
immediately at the conclusion of the research project using VA established regulations. Research records, 
including identifiers will be destroyed 6 years after cutoff (at the end of the fiscal year) after completion of the 
research project, but may be retained longer if required by other federal regulations or sponsor archive 
requirement. 
Describe how adequate written assurances exist in order to ensure that the PHI will not be reused or disclosed to 
(shared with) any other person or entity, except as required by law, for authorized oversight of the research study, 
or for other research for which the use or disclosure of the PHI would be permitted under the Privacy Rule. 
    
Adequate written assurances exist in order to ensure that the PHI will not be reused or disclosed to (shared with) 
any other person or entity, except as required by law, for authorized oversight of the research study, or for other 
research for which the use or disclosure of the PHI would be permitted under the Privacy Rule, because all 
gathered PHI for potential participants will be stored in a locked file cabinet in a locked data storage room behind 
the VA firewall. No one outside of the PI, PI's research coordinator, Baylor College of Medicine Institutional 
Review Board members, VA Research and Development office and research compliance officers will have 
access to the data or limited PHI information 
 
Information from health records such as diagnoses, progress notes, medications, lab or radiology findings, etc.
    Yes 
Specific information concerning alcohol abuse:
    Yes 
Specific information concerning drug abuse:
    Yes 
  
Specific information concerning sickle cell anemia:
    No 
Specific information concerning HIV: 
    No 
Specific information concerning psychiatry notes:
    Yes 
Demographic information (name, D.O.B., age, gender, race, etc.): 
    Yes 
Full Social Security #: 
    No 
Partial Social Security # (Last four digits):
    Yes 
Billing or financial records: 
    No 
Photographs, videotapes, and/or audiotapes of you:
    Yes 
Other: 
    No 

Will additional pertinent information be provided to subjects after participation?
    No 
If No, explain why providing subjects additional pertinent information after participation is not appropriate. 
    
Providing participants additional pertinent information after participation is not appropriate, because this 
information has already been shared with the participant by other clinicians. All additional information gained 
from the additional assessments and semi-structured interviews will be provided by the patient. Thus, there will 
not be any new information gained that the participant will not already know or have provided 
  
J1a.  Waiver of requirement for written documentation of Consent 
Will this research require a waiver of the requirement for written documentation of informed consent?
    Yes 
Explain how the research involves no more than minimal risk to the participants, and the specifics demonstrating 
that the research does not involve procedures for which written consent is normally required outside of the research 
context. 
    
We are requesting permission to verbally consent patient participants to this study by telephone. Given the 
treatment and research assessments are non-invasive in nature and almost exclusively involve monitoring and 
assessment of patient functioning, we have established telephone-based contact methods to decrease 
participant burden. To further improve this process, we are requesting to verbally consent participants to afford 
us greater opportunities to increase our outreach to patients and decrease participant burden . Patients will be 
initially introduced to the study and screened by telephone. If the initial screen indicates the patient may be 
eligible for the study, the patient will be mailed detailed information about the study procedures and an informed 
consent document (without signature lines) for their review. The study coordinator or other research staff will 
then follow up with the patient by telephone. Telephone consent will occur before administering baseline 
measures. Our protections for confidentiality are described below. The telephone screening will be conducted 
using a structured script (attached in section S). 
J2.  Consent Procedures 
Who will recruit subjects for this study?
    PI 
PI's staff
Describe how research population will be identified, recruitment procedures, any waiting period between informing 
the prospective participant and obtaining consent, steps taken to minimize the possibility of coercion or undue 
influence and consent procedures in detail. 
    
Patients receiving care in the inpatient stroke unit and the outpatient stroke clinic at the MEDVAMC will be 
targeted for treatment. Recruitment will take place based on referrals via the attending physical and nurses in the 
inpatient and outpatient stroke clinics at the MEDVAMC. The study coordinator will contact potential participants 
by mail or by phone. During this initial contact, a recruitment letter will be read to all potential subjects. A copy of 
the letter is available in section S. The letter will provide an overview of the study. Interested participants 
undergo an initial in person or telephone screening in order to determine eligibility. Participants who meet the 
inclusion criteria will then be provided with a hard copy of the consent and HIPPA form to be reviewed with study 
coordinator in person or via phone. The baseline assessment will be conducted after telephone consent has 
been obtained, and will last approximately 1 hour. After the verbal consent has been obtained the study staff will 
also assist with setting up video telehealth app and or review telephone usage, if applicable, and answer any 
additional questions. The baseline forms will gather demographic data such as age, gender, ethnicity, race, 
education, marital status, and employment. Participants will be asked about medications, other therapies, and 
hospitalizations. Additional assessments will measure mental health diagnosis and symptom severity. 
Participants who do not meet the inclusion criteria but demonstrate a need or ask for additional services will be 
referred for VA and community based mental health care services. 
 
Are foreign language consent forms required for this protocol? 
    No 
J3.  Privacy and Intrusiveness 
Will the research involve observation or intrusion in situations where the subjects would normally have an 
expectation of privacy? 
    No 
J4.  Children 

Will children be enrolled in the research? 
    No 
J5.  Neonates 
Will non-viable neonates or neonates of uncertain viability be involved in research? 
    No 
J6.  Consent Capacity - Adults who lack capacity 
Will Adult subjects who lack the capacity to give informed consent be enrolled in the research?
    No 
J7.  Prisoners 
Will Prisoners be enrolled in the research? 
    No 
  
Section K:  Research Related Health Information and Confidentiality 
Will research data include identifiable subject information?
    Yes 
Information from health records such as diagnoses, progress notes, medications, lab or radiology findings, etc.
    Yes 
 
Specific information concerning alcohol abuse:
    No 
Specific information concerning drug abuse:
    No 
 
Specific information concerning sickle cell anemia:
    No 
Specific information concerning HIV: 
    No 
 
Specific information concerning psychiatry notes:
    Yes 
Demographic information (name, D.O.B., age, gender, race, etc.): 
    Yes 
Full Social Security #: 
    No 
 
Partial Social Security # (Last four digits):
    Yes 
Billing or financial records: 
    No 
Photographs, videotapes, and/or audiotapes of you:
    Yes 
Identifiable biospecimens 
    No 
Other: 
    No 
At what institution will the physical research data be kept? 
    The physical research data will be stored in a locked cabinet located at HSR&D CoE located at the Nabisco 
Building, 2450 Holcombe Boulevard, Suite O1Y, Houston, TX (Rm 121). No data will eave the MEDVAMC. 
How will such physical research data be secured? 

    
All forms of original data collected from this study will be stored in the VA Health Services Research and 
Development Center of Excellence (HSR&D C0E) which meets VA and BCM security requirements. These data 
will be stored in a locked cabinet located at HSR&D CoE located at the Nabisco Building, 2450 Holcombe 
Boulevard, Suite O1Y, Houston, TX (Rm 121). These data are stored behind 3 locked doors and to minimize risk 
to confidentiality, all data, including paper/pencil measures, will be labeled with partici pant numbers and only 
study personnel and members of the Data Monitoring and Safety Board will have access to these data. 
Research records, including identifiers will be destroyed 6 years after cutoff (at the end of the fiscal year) after 
completion of the research project, but may be retained longer if required by other federal regulations or sponsor 
archive requirement. 
 
At what institution will the electronic research data be kept? 
    
All electronic de-identified research data will be kept on a secure server of the MEDVAMC (VA server at the VA 
Health Services Research and Development Center of Excellence (HSR&D C0E) which meets VA and BCM 
security requirements. Data will be maintained on the secure servers of the HSR&D CoE located at the Nabisco 
Building, 2450 Holcombe Boulevard, Suite OIY, Houston, TX. During business and non -business hours, access 
to the server is behind locked doors. The server is backed up automatically each night. Data will be stored in 
folders on the M drive (M:RESEARCH/IMWHOLE/H43730) and only the research study staff will be given 
permission (requiring a logon and password) to access these folders. Results that are presented for publication 
will be reported in aggregate form, and therefore will not contain individual identifying information. No data will 
leave the MEDVAMC. 
 
Such electronic research data will be secured via BCM IT Services- provided secured network storage of electronic 
research data (Non-Portable devices only): 
    No 
Such electronic research data will be secured via Other: 
    
Yes, (describe below): 
Yes, (describe below): Data will be maintained on the secure servers of the HSR&D CoE located at the Nabisco 
Building, 2450 Holcombe Boulevard, Suite O1Y, Houston, TX. During business and non -business hours, access 
to the server is behind locked doors. The server is backed up automatically each night. Data including digitally 
encrypted audio recordings, will be stored in folders on the M drive (M:RESEARCH/IMWHOLE/H43730) and only 
the research study staff will be given permission (requiring a logon and password) to access these folders. 
Will there be anyone besides the PI, the study staff, the IRB and the sponsor, who will have access to identifiable 
research data? 
    
Yes, identify the classes of the persons: 
People who ensure quality from the institutions where the research is being done, federal and other regulatory 
agencies will have access to all of the research data. 
Please describe the methods of transmission of any research data (including PHI, sensitive, and non -sensitive data) 
to sponsors and/or collaborators. 
    No data will leave the MEDVAMC. 
  
Will you obtain a Certificate of Confidentiality for this study?
    No 
Please further discuss any potential confidentiality issues related to this study.
    There are no foreseeable issues with confidentiality. 
 
  
Section L:  Cost/Payment 
Delineate clinical procedures from research procedures. Will subject's insurance (or subject) be responsible for 
research related costs? If so state for which items subject's insurance (or subject) will be responsible (surgery, 
device, drugs, etc). If appropriate, discuss the availability of financial counseling. 
    0.00 
If subjects will be paid (money, gift certificates, coupons, etc.) to participate in this research project, please note the 
total dollar amount (or dollar value amount) and distribution plan (one payment, pro -rated payment, paid upon 
completion, etc) of the payment. 
Dollar Amount: 
    60 

Distribution Plan: 
    Each participant in phase II and phase III will receive 20.00 for each assessment they complete (0/6/12 weeks). 
  
Section M:  Genetics 
How would you classify your genetic study?
    
Discuss the potential for psychological, social, and/or physical harm subsequent to participation in this research. 
Please discuss, considering the following areas: risks to privacy, confidentiality, insurability, employability, 
immigration status, paternity status, educational opportunities, or social stigma. 
    
Will subjects be offered any type of genetic education or counseling, and if so, who will provide the education or 
counseling and under what conditions will it be provided? If there is the possibility that a family's pedigree will be 
presented or published, please describe how you will protect family member's confidentiality? 
    
  
Section N:  Sample Collection 
None
  
Section O:  Drug Studies 
Does the research involve the use of ANY drug* or biologic? (*A drug is defined as any substance that is used to 
elicit a pharmacologic or physiologic response whether it is for treatment or diagnostic purposes)  
    No 
Does the research involve the use of ANY gene transfer agent for human gene transfer research?
    No 
O1.  Current Drugs 
  
Is this study placebo-controlled?
    No 
Will the research involve a radioactive drug?
    No 
 
  
Section P:  Device Studies 
     Does this research study involve the use of ANY device? 
        No 
  
Section Q.  Consent Form(s) 
None
  
Section R:  Advertisements 
Mode of Advertising:  Billboard 
Exact language of Advertisement: 
    
People who have had a stroke often experience sadness and worry. Untreated or poorly managed sadness 
and/or worry can cause poor progress after having a stroke and cause people to spend less time exercising or 
being with their family and friends. 
The overall goal of this program is to develop, refine, and see if the I’m Whole treatment for Veterans with stroke 
and sadness and worry helps improve your way of living. 

If you have had a stroke in the past year and have sadness and/or worry and would like to receive additional 
strategies to help you perform better physically and socially then I’m Whole can help. If you are interested in 
hearing more about the program please contact: 
Dr. Gina Evans Principal Investigator (713) 440 – 4459 2002 Holcombe Blvd. 
Thank you for your time and welcome to the I’m Whole program!