Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline
Phase: NA
Conditions: Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease), Uncontrolled Diabetes (HBA1c ≥ 10)
Sponsor: University of Illinois at Chicago

 
 
 
Piloting the IPROACTIF 
Program to Preserve 
Functioning & Prevent 
Cognitive Decline 
2020-1461: NCT: 04682977     Principal Investigator: 
Mansha Parven Mirza, PhD.  Date: May 17, 2022 
 
 
 
 

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Office for the Protection of Research Subjects 
(OPRS) 
Institutional Review Board 
FWA# 00000083 
Initial Review Application: Social, 
Behavioral, and Educational 
Research  
  
Form Version # & Date: 5.2; 03/09/2020  
  
201 AOB (MC 672) 
1737 West Polk Street 
Chicago, IL 60612-7227 
Phone: 312 996-1711 
 
http://research.uic.edu/human-subjects-irbs/ 
 
 
 
 
 
 
II. Personnel 
A. Principal Investigator (PI) 
Name (Last, First) 
Mirza, Mansha 
Degree(s) 
PhD, OTR/L 
Net ID (e.g., NetID@uic.edu) 
mmirza2 
Department 
Occupational Therapy 
College 
Applied Health 
Sciences 
University Status 
Student/Fellow/Resident 
Faculty/Staff 
Phone Number 
312-35505427 
UIC E-mail Address 
mmirza2@uic.edu 
 
B. Faculty Sponsor – Complete only when PI is a student, fellow, or resident 
Name (Last, First) 
Degree(s) 
Net ID (e.g., NetID@uic.edu) 
Department 
College 
Phone Number 
UIC E-mail Address 
 
C. Primary Contact In Addition to PI – Complete only if the primary contact person is different than the 
PI 
Name (Last, First) 
Net ID (e.g., NetID@uic.edu) 
Phone Number 
UIC E-mail Address 
Principal Investigator grants this personnel access to OPRS Live for this protocol 
 
D. List all co-investigators and key research personnel on Appendix P and upload with this 
application packet. 
 
 
III. Performance Sites 
Date application completed by the Investigator: 4.26.22 
I. Research Title: 
Piloting the IPROACTIF program to preserve functioning and prevent cognitive decline 

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A. Are there non-UIC performance sites? 
No – Skip to Section IV. 
Yes – Complete Appendix K and upload with this application packet 
 
IV. Research Funding 
A. Is this research funded? 
No – Skip to Section V. 
Yes 
Pending 
B. Check all of the appropriate boxes for funding sources (including pending sources) for this 
research. If the study is supported by more than one funding source, complete and upload Appendix 
Z for each additional funding source. 
  Federal Agency Name:National Institutes of Health 
Foundation Name: 
State Agency Name: 
Department of Defense – Complete Appendix Q and upload with this application packet 
Sub-contract from non-UIC agency or institution: Name: 
Other - Name: 
C. Funding Identification: 
1. Institutional Proposal (IP) Number: 
0045807 
2. a. Name of the PI on the grant or contract received directly from the sponsor: Susan Hughes 
b. Is the PI of this grant or contract affiliated with UIC? 
No – Identify the agency or institution with which the above PI is affiliated: 
Explain the relationship between that agency or institution and UIC: 
Yes 
c. Grant, contract or sub-contract title: Midwest Roybal Center for Health Promotion 
and Translation 
d. Grant, contract or sub-contract number: 5P30AG022849-17 
 
V. Conflict of Interest (COI) 
 
 
A. Disclosure 
1. At present or in the 12 months prior to this disclosure, did or does any investigator or investigator’s 
family members have a significant financial interest (SFI) with the research sponsor or any 
subcontract recipient; or have a SFI reasonably related to a product (e.g., drug, device, method, 
treatment, etc.) that is the subject of the research; or have any other relationships (e.g. fiduciary, 
even if uncompensated) that may present a potential conflict of interest with this research? 
No 
Yes – See Section B below. 
 
2. Are you aware of an institutional conflict of interest with this study? 
Definition of a Performance Site: A performance site is a location at which the research is conducted, 
data is gathered from subjects and/or records, and/or subjects are consented into the research. Sites are 
performance sites whether the research activities there are funded or not funded. 
All investigators must disclose all real, apparent, or potential Significant Financial Interest (SFI) to the 
IRB. For more information, see the Investigator Conflict of Interest Disclosure Policy for Human 
Subjects Research. 

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No 
Yes – See Section B below. 
 
 
B. Management 
If YES is checked for any of these questions, complete the disclosure and management plan via 
START myDisclosures application (https://myresearch.uillinois.edu/myDisclosures/). Guidance can 
be found on the COI website under “Managing Conflicts”. 
Final IRB approval of the research 
cannot be provided until a management plan is in place and is approved by the IRB. For additional 
assistance contact the COI Office at (312) 996-3642 / (312) 996-4070 or email coi@uic.edu. 
 
VI. Protocol Components 
A. Provide a description of the background and rationale for the proposed research. Cite appropriate 
literature to support the relevance and importance of this research. 
 
 
B. State the research objectives/hypothesis being explored by the current research. Please include 
primary and secondary aims. 
 
Chronic conditions such as diabetes and heart disease entail cardiovascular risk factors 
which play a critical role in cognitive decline1. The majority of aging adults presenting 
with these conditions and associated cardiovascular risk factors such as obesity, 
hyperlipidemia, hypertension, and physical inactivity, are treated in primary care 
settings. Thus, primary care offers an opportunity to help patients manage chronic 
conditions, modify cardiovascular risk factors, and prevent cognitive decline2. One 
promising way to identify and target at-risk patients in primary care settings is through 
focus on activities and instrumental activities of daily living (ADLs and IADLs). 
Primary care patients with chronic disease(s) and cardiovascular risk factors are more 
likely to be in the stage of preclinical cognitive changes. Converging evidence indicates 
that subtle deficits in ADL and IADL performance precede clinically identifiable 
cognitive impairment. ADL limitations are also strong predictors of progression 
between normal cognition, mild cognitive impairment (MCI), and dementia3-5. 
Evaluation and rehabilitation of ADL/IADL performance in at-risk patients can 
activate a positive cycle of ADL independence, better management of chronic disease, 
lowering of cardiovascular risk factors, and prevention/deceleration of cognitive 
decline. However, there is a dearth of evidence-based interventions that focus on 
ADL/IADL training for at-risk aging patients in primary care. 
 
C. Clearly describe the study design/intervention. The description should demonstrate how the stated 
objectives will be met. 
 
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and 
Chronic Disease Treatment to preserve Independence and Functioning) is an 
intervention designed to be delivered in primary care settings by an on-site 
occupational therapist. Based on the premise of preventing the physical and cognitive 
decline that is associated with aging and chronic disease, the 12-week intervention 
includes a comprehensive assessment of ADL functioning and ten intervention sessions 

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addressing disease management, physical activity and executive functioning. The 
intervention is designed for adults, aged 55 and over, with a primary diagnosis of 
diabetes or heart disease, and pre-clinical cognitive decline. We propose a study to 
assess the efficacy of IPROACTIF in a pilot randomized control trial with a control 
group receiving usual primary care services. 
 
The intervention comprises three components spread across 12 weekly sessions: (1) 
comprehensive assessment of physical and executive functioning i.e. person factors 
(Session 1) using the Physical Performance Test, the Dimensional Change Card Sort, 
and the Executive Function Performance Test, (2) assessment of home safety and 
accessibility i.e. environmental factors using the HOME Falls and Accidents Screening 
Tool (Session 2), and (3) assessment of ADL/IADL competence and performance in 
context i.e. occupational factors using the Performance Assessment of Self-Care Skills 
(Session 2). Information in these areas is used by the interventionist to collaboratively 
identify three patient-centered goals. To facilitate this process, we have developed an 
agenda mapping script and a goal planning worksheet based on principles of 
motivational interviewing. Goal planning is followed by 12 in-person treatment 
sessions. Treatment sessions focus on chronic disease education, problem solving issues 
related to disease management by modifying daily routines, recommendations for 
embedding physical activity in everyday tasks, and environmental modifications or 
activity adaptations to increase ADL/IADL independence. The goal planning worksheet 
is revisited at every session to ensure patient-centeredness. Thus, while the intervention 
is manualized, it also includes built in flexibility for individualized patient goals and 
treatment plans. 
D. Describe in chronological order all the tasks/tests or procedures subjects will be asked to complete in 
participating in this research. Distinguish between tasks performed solely for research and those 
being performed for non-research purposes. 
At the beginning of the study participants will be asked to complete phone surveys and 
assessments in-person and by video/phone call. These activities will take place in the 
following order 
• 
Phone surveys – Participants will be asked to complete demographic and 
background surveys (including self-reported height and weight) and 
assessments about their health, healthcare utilization, and daily activities. 
• 
In-person assessments – A week to ten days after the phone surveys, participants 
will be asked to visit the study occupational therapist at the faculty practice clinic at 
1640  
W. Roosevelt Road or in the Department of Occupational Therapy, 3rd floor, 1919 W. 
Taylor Street. During this visit, the therapist will assess their physical and mental 
functioning using a variety of standard tests. The therapist will also give each 
participant an accelerometer to take home and teach them how to wear it. 
• 
Video/Phone call assessment – A week after the in-person visit, the therapist will 
make an appointment for a video/phone call with each participant. During the 
video/phone call, the therapist will observe the participant performing one or two daily 
living tasks in their home. 
• 
Wearing the accelerometer – During the week between the in-person visit and the 
video/phone call, we will ask participants to wear the accelerometer for at least 12 
hours a day for 7 days. The accelerometer along with a stamped and self-addressed 
return envelope will be provided to the participant at the end of their in-person visit. 

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During this visit, the therapist will explain the purpose of the accelerometer and 
demonstrate how to wear it. The participant will be informed that a research assistant 
will contact them by 

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phone after a week to check if they are wearing the accelerometer and answer any 
questions. If participants have completed their 7-day data collection period, they will be 
asked to return the accelerometer using the envelope provided. If not, they will be 
instructed to start wearing the accelerometer at their earliest convenience. A research 
assistant will check on the participant by phone again after a week. If the participant 
has still not begun wearing the accelerometer they will be reminded to do so at their 
earliest. After another week, a final reminder call will be made, and if the participant 
does not intend to wear the accelerometer, they will be asked to return it using the 
envelope provided. 
 
After completing surveys and assessments participants will be randomly assigned to a 
treatment or control group. Participants in the treatment group will participate in ten 
sessions with an occupational therapist. Sessions will be held via video/phone call, will 
take place weekly and will last 30-45 minutes. During these sessions the therapist will 
work with each participant to understand their strengths and challenges in doing day-
to-day activities and to improve their physical fitness and mental alertness. At the 
beginning of treatment, the therapist will help participants set three health-related 
goals. 
 
• 
Sessions 1-3: The first three sessions will focus on the first health-related goal. 
During Session 1, the therapist will discuss how age and chronic disease affect physical 
functioning. The therapist will work with each participant to develop a step-by-step 
plan to achieve their goal. In Session 2, the therapist will offer advice on action steps 
toward that goal. These steps might include physical activity and exercise, or changes to 
the environment so that day-to-day activities are easy and safe. In Session 3, the 
therapist will follow-up on progress and help problem-solve barriers. 
• 
Sessions 4-6: These sessions will focus on the second health-related goal. Activities 
conducted during these sessions will be similar to those conducted during Sessions 1-3. 
• 
Sessions 7-9: These sessions will focus on the third health-related goal. Activities 
conducted during these sessions will be similar to those conducted during Sessions 1-3. 
• 
Session 12: During this session, the therapist will discuss the overall progress you 
made on your health goals. The therapist will also check with you to make sure you 
have gained knowledge about your health and how to improve it. The therapist will 
share tips to maintain the gains you have made in your physical and mental 
functioning. 
 
Participants in the control group will not receive treatment sessions with the 
occupational therapist. They will only receive weekly check-in phone calls from a 
research assistant that will last 5-10 minutes. They will have the opportunity to receive 
occupational therapy services after completion of the study. 
 
Follow-up Surveys and Assessments 
Twelve weeks after beginning the study, all participants will complete the same surveys 
and assessments completed during the beginning of the study. These surveys and 
assessments will be completed in the same order and using the same format as at the 
beginning of the study. Participants in the treatment group we will also complete a brief 
satisfaction survey. 

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In addition, we will also record blood pressure and HBA1C readings from participants’ 
medical records AFTER we have obtained consent from participants. For participants in 
the treatment group, we will use readings from their last visit with the PCP before the 
intervention and closest visit with the PCP after the intervention.  For participants in the 
control group, we will use the information that is available in their medical records from the 
last available record before the date of completing the baseline surveys and assessments, 
and the next available record approximately 10 weeks after the date that they complete the 
baseline surveys and assessments. 
 
Two occupational therapists will also be involved in the study and will provide the 
aforementioned intervention sessions to all patient participants. Some of these sessions 
might be monitored (observed in real-time) by the PI or a research assistant as part of 
fidelity monitoring 
 
The entire study will last about 12-15 weeks. 
 
E. Describe the plans for data analysis. If applicable, include statistical considerations and justification 
for subject population and planned enrollment numbers. 
We will use paired t-tests or Wilcoxon Signed-rank tests (nonparametric) to examine 
differences between pre and post-intervention scores for the two groups. Between- 
group differences, variability, and effect size in outcome measures will be used to 
project sample size for future trials. Our analytical strategy for future trials is to 
estimate difference between groups in change over repeated measures (i.e. "group-by- 
time interaction"). We will use Pearson correlation to examine association between 
physical functioning and executive functioning, and between ADL/IADL performance 
and executive functioning. 
F. Is this is a clinical trial? 
No – Skip to section VII 
Yes - Is the research required to be registered on http://clinicaltrials.gov? For more information, 
refer to the UIC HSPP policy Clinical Trials Registration 
No 
Yes – Include the required language within the informed consent document. 
 
VII. Research Records 
A. Indicate the type(s) of data being collected and/or recorded (check all that apply): 
X  Interviews/Questionnaires 
Audio recordings 
Video recordings 
Photographs 
School/Student records 
Internet research data 
Lab, pathology and/or radiology results 
X University of Illinois Hospital & Health System medical records – University of 
Illinois Hospital & Health System medical records (only HBA1c and 
Systolic/Diastolic blood pressure readings from last visit with PCP before the 
intervention and closest visit with the PCP after the intervention – patients will NOT 
be asked to make an appointment just for the study. For participants in the control 
group, we will use the information that is available in their medical records from the 

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last available record before the date that that they completed the baseline surveys and 
assessments, and the next available record approximately 10 weeks after the date that 
they complete the baseline surveys and assessments. For participants in both groups 
these data will be abstracted AFTER consent is obtained. 
 
Physician/clinic/hospital medical records from sources outside of UI Health System 
Psychotherapy Notes 
Billing records 
Data previously collected for research purposes 
Data containing no health information 
Study-generated health information 
Biological specimens 
X Other. Describe: Performance-based observations by a clinician 
No audio/video recordings will be collected during the course of the study 
 
B. Will any of the following be banked or stored for future (planned or unplanned) analysis beyond the 
scope of the current research proposal? If the following will be used and/or destroyed prior to the 
closure of the research, they are not considered to be stored; therefore, please answer “No”. 
• 
biological samples or specimens 
• 
identifiable data, 
• 
coded data where a master list to the codes exists 
  No Study assessments are only intended to generate data that will help monitor intervention 
and/or test study hypotheses. These data should not be considered health information. 
Yes – Complete Appendix D and upload with this application packet. 
 
 
VIII. Research Subject Population 
A. Indicate the anticipated subject enrollment number (This number cannot be exceeded without 
prior IRB review and approval via an amendment): 75 
B. Indicate which populations below are the PRIMARY FOCUS of this research. Please refer to the UIC 
HSPP policies regarding the incidental enrolment of select vulnerable populations (i.e., decisionally 
impaired, prisoners, etc.). 
 
Check all that apply 
Adults (18 years of age and older) 
Minors (17 years of age and younger) – Complete Appendix B (required regardless of primary 
or incidental enrollment) and upload with this application packet 
Pregnant Women, Neonates, Fetuses/Fetal Tissue – Complete Appendix U and upload with this 
application packet 
Prisoners – Complete Appendix C and upload with this application packet - Please note that 
certain types of research with prisoners approvable under the federal regulations may not 
be allowed under Illinois state law including, but not limited to, biomedical research. 
UIC Employees 
UIC Psychology Student Subject Pool - 
• Complete Appendix S and a debriefing document and upload with this application packet; 
• Complete and upload Appendix B if the research will involve Pool subjects who are minors. If 
minors will be excluded, then a scientific justification must be provided under item VIII.D.1.b, 
below. 
UIC Management Study Pool - Complete Appendix S and a debriefing document and upload with 
this application packet 
Students - Complete Appendix S (required only if the research involves classroom activities and/or 
Note: A plan for securely storing the data must be submitted for IRB review and approval if identifiable 
and/or coded data will be retained after the research has been completed. Development of a separate 
data/tissue repository/bank research protocol is required if the investigator will be retaining data from 
multiple proposals. 

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student records) and upload with this application packet 
Decisionally-Impaired - Complete Appendix V and upload with this application packet 
Economically and/or Educationally Disadvantaged 
Vulnerable to Coercion or Undue Influence 
Other: specify 
 
 
C. If including economically and/or educationally disadvantaged subjects, subjects vulnerable to 
coercion or undue influence, UIC Employees, and/or other populations that may be considered 
vulnerable, provide a rationale for their inclusion and what additional safeguards, if any, are in place 
to protect their rights and welfare: 
Two UI Health clinicians will be included in the study as the lead interventionists. They 
will provide data about the treatment sessions, which is necessary to monitor the 
fidelity of the experimental intervention. Specifically, the PI or a research assistant will 
attend and observe randomly selected treatment sessions and will complete a fidelity 
monitoring checklist based on their observations of the clinician’s delivery of the session 
(uploaded). Clinicians will also be asked to complete case notes for each treatment 
session. The case notes template is embedded in the intervention manual. 
D. Eligibility Criteria 
1. Provide specific details regarding the following: 
a. Inclusion Criteria: For patient participants: 
- Age 55 years or over 
- Primary diagnosis of one or more of the following: diabetes ,heart disease 
- 
Evaluated as experiencing or being at risk of functional decline OR self-identified 
need for support with chronic disease management and functional health 
 
For clinician participants: 
- A certified occupational therapist licensed to practice in the state of Illinois 
- A minimum of 5 years clinical experience 
b. Exclusion Criteria: For patient participants: 
- Unable to participate in study activities due to time or other constraints 
- Current/past diagnosis of stroke or dementia, or other neurological disorders 
- Receiving pharmacological treatment for cognition 
- 
Participation in other clinical trials involving a rehabilitation/functional 
health management component 
- Non-English speaking 
- Residing in a long-term care institution 
- Compromised decision-making capacity (score >8 on SOMCT) - - Short Orientation 
Memory Concentration Test (SOMCT) will be used during the screening process to 
ensure the participant is eligible for the study. A score of 0-8 on this test indicates 
normal to minimal impairment. Any one with a score>8 will be considered ineligible. 
 - Not an active patient at the study clinic (two years or more since last appointment) 
 
For clinician participants: 
- Unable to participate in study activities due to time or other constraints. Please note, 
recruitment and eligibility sections have not been completed for clinicians as the clinicians 
have already been selected and will serve as co-investigators on this study. 
 
2. Explain how and by whom potential subjects will be assessed to determine their eligibility for the 
research: A trained research assistant and graduate student in occupational therapy will 
assess potential subjects to determine eligibility using a screening questionnaire 
administered over the phone 
 
3. Explain how initial eligibility will be documented (upload any screening documents): For patient 
participants: We have developed an eligibility screening form (attached) to ascertain eligibility of 
potential subjects. The screening form will include a standardized assessments for assessing risk 

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of functional decline. Functional decline will be assessed using the Brief Risk Identification of 
Geriatric Health Tool (BRIGHT). Subjects will be flagged as being at risk of functional decline if 
they get a score of >=3 on the 11 item BRIGHT. The entire screening procedure will be completed 
by a trained research assistant. We will maintain an Excel spreadsheet to document eligibility. The 
spreadsheet will be anonymized and subjects will only be identified by a serial number. For 
provider participants: We will not be documenting eligibility for clinicians. 
 
 
4. Explain how subjects will be monitored during the course of the research to ensure that they still 
meet the eligibility criteria and how their continuing eligibility will be documented: 
For patient participants: Participants in the intervention group (occupational therapy) will 
be continuously monitored by the occupational therapist who will administer the 
experimental intervention. The occupational therapist will monitor patients for any 
worsening in cognitive functioning. Being in close contact with patients, she will also be 
aware of changes in residential situation (e.g. move to a nursing home) and enrollment in 
other studies that might render participants no longer eligible for this study. Participants 
in the control group will also be closely monitored by a research assistant through weekly 
phonecalls to monitor for changes in cognitive functioning, living arrangement (i.e. 
relocation to nursing home), and enrollment in other studies. 
 
We will not be monitoring eligibility for clinician participants. 
OR 
N/A – Assessment of continued eligibility is not required 
 
IX. Recruitment of Subjects 
A. Describe how potential subjects will be initially identified for this research study. 
Potential subjects will be recruited in the following ways: 
1, Potential participants will be identified by their physicians or other primary healthcare 
providers including nurses, pharmacists, occupational therapists, and care coordinators. We 
will conduct in-service trainings about the study and eligibility criteria with clinical staff at 
three UI Health Clinics - University of Illinois Family Medicine Center, University Village; 
University of Illinois Geriatric Outpatient Clinic; University of Illinois Endocrinology 
Outpatient Clinic. A presentation template for this purpose is attached. 
A flyer advertising the study will then be disseminated via physicians, nurse practitioners, 
and other clinical staff working at these clinics. The flyer will include a phone number that 
patients can call or further information about the study. 
Alternatively, patients can complete a brief form on the flyer with their contact information and 
indicating their permission to be contacted by the research team. Physicians and other staff 
will contact the research team to schedule a time for a research assistant to pick up 
completed flyers. 
 
The research assistant will then contact eligible individuals by phone and screen them for the 
study's inclusion criteria. Individuals who meet inclusion criteria will be invited to enroll in the 
study and set up a phone appointment for completion of consent procedures and baseline 
data collection. 
 
Due to the COVID-19 pandemic, some providers such as care coordinators are not seeing 
patients in-person.  We have developed an alternative secure strategy for the providers to 
share the study flyer with patients and pass on completed flyers to the study team. The 
details are described under section IX B below. Note that care coordinators will be identifying 
potential patients in the same way as physicians, nurses, and pharmacists described above 
i.e. based on study eligibility criteria which will be shared with care coordination staff during 
an in-service presentation. 
 
 

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2. Through electronic medical records – This will be done at two of the recruitment clinics. At the U 
of I Family Medicine Center, this will be done in two ways: [1] a data manager (member of the 
health iformatics team) who has completed training in HIPPAA compliance (specifically the UI 
Health Learning Management System (LMS) registration course for enhancing research compliance 
when using EHRs) will use electronic medical records to generate a list of individuals who meet 
study inclusion criteria. This individual is not a key research personnel listed in the Appendix P. 
This someone who works at the clinic and will only abstract the data and transfer it to the UIC Box 
of the researchers [2] some physicians at the U of I Family Medicine who also have health formatics 
training will use EMRs to identify their own patients who meet study inclusion criteria. They will 
then send these patients a one-time bulk message via the patient portal which will include the study 
flyer as an attachment (please see the next section). A spreadsheet containing names and contact 
information of eligible individuals identified using either of the above strategies will be uploaded to a 
subfolder within a secure UIC Box Health folder. This spreadsheet will also include the patient’s 
primary diagnosis (diabetes or heart disease). Only names, contact information (specifically emails 
and phone numbers) and the primary diagnosis (i.e. diabetes or heart disease) will be abstracted 
from medical records at recruitment and prior to subjects’ enrollment. Only the PI and key 
research personnel will have access to this spreadsheet;  
 
At the U of I Endocrinology Clinic, a study research assistant who has completed training in HIPAA 
compliance will access electronic medical records to generate a similar list as above. A spreadsheet 
containing names and contact information of eligible individuals from this clinic will be uploaded to 
the same secure UIC Box Health folder described above. 
 
 
B. Describe how, where, when, and by whom subjects will be recruited for the research. 
Recruitment will be conducted in four ways: 
1. Recruitment via primary care providers seeing patients in-person - Potential 
participants will be identified by their physicians or other primary healthcare providers 
including nurses, pharmacists, occupational therapists, and care coordinators. We will 
conduct in-service trainings about the study and eligibility criteria with clinical staff at 
three UI Health Clinics - University of Illinois Family Medicine Center, University 
Village; University of Illinois Geriatric Outpatient Clinic; University of Illinois 
Endocrinology Outpatient Clinic. A flyer advertising the study will be disseminated via 
physicians, nurse practitioners, and other clinical staff working at these clinics. 
Providers who are seeing patients in-person will share the flyer with their patient at the 
end of their regular scheduled appointment. A script has been created for introducing 
the flyer to specify that the decision to participate in the study is voluntary, that the 
providers themselves are not members of the research team, and that choosing to 
participate or not will not affect services received at the clinic [Note that the two 
clinicians who will be serving as study interventionists also work at two of the 
recruitment clinics. A separate script has been created for them to introduce the study 
to patients which specifies they are research personnel associated with the study – we 
have also addressed this in Section IX C]. The flyer will include a phone number that 
patients can call or further information about the study. Alternatively, patients can 
complete a brief form on the flyer with their contact information and indicating their 
permission to be contacted by the research team. Physicians and other staff will contact 
the research team to schedule a time for a research assistant to pick up completed flyers. 
 
The research assistant will then contact eligible individuals by phone and screen them 
for the study's inclusion criteria. Individuals who meet inclusion criteria will be invited 

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to enroll in the study and set up a phone appointment for completion of consent 
procedures and baseline data collection. 
2. Recruitment via primary care providers seeing patients remotely – Some providers, 
specifically care coordinators, are only seeing patients remotely (via phone or video 
conferencing using the Doxy.me platform) due to the COVID19 pandemic. They will 
share the flyer with their patient at the end of their regular scheduled appointment. 
These providers will share the flyer with their patient at the end of their regular 
scheduled REMOTE appointment. A separate script and instructions have been 
created for them to introduce the study to their patient. They will also be asked to offer 
to read the contents of the flyer for the patient verbatim, with no deviation. If a patient 
has questions about the study, they will be asked to contact the research team directly 
using the number stated on the flyer. If a patient is willing for their contact 
information to be shared with the study team, the provider will ask if they can 
complete the brief form at the end of the flyer on the patient’s behalf. Information 
noted in the flyer (name and phone number) will be retrieved directly from the patient 
and NOT from their EHR. The completed flyer will then be uploaded to a separate 
subfolder (different from the one described in #1 above) within the study’s secure UIC 
Box Health folder. Patients will be informed and made aware of this procedure. Of 
note, care coordinators will only be granted ‘uploader’ access to this folder. This 
means that they will be unable to see completed flyers uploaded by other care 
coordinators. 
The research assistant will then contact eligible individuals by phone and screen them 
for the study's inclusion criteria. Individuals who meet inclusion criteria will be invited 
to enroll in the study and set up a phone appointment for completion of consent 
procedures and baseline data collection. 
 
3. In person recruitment by a member of the research team – This will be done only at the U 
of I Endocrinology clinic. One or two days a week, a trained research assistant will 
shadow physicians and/or nurse practitioners as they consult with patients. The research 
assistant will not accompany the physician/NP into an exam/consultation room but will 
wait outside until the visit is complete. Patients who might be eligible for the study will be 
identified by physicians and/or nurse practitioners based on the study’s inclusion criteria 
which they will be informed about during presentations about the study at clinical/staff 
meeting. Clinicians will introduce their patient to the research assistant at the end of their 
visit/consultation. A script has been created for this purpose. Then, the patient will have 
the option to meet separately with the research assistant to learn more about the study. 
The research assistant will then meet one-on-one with patients who express verbal interest 
in learning about the study. This meeting will take place in a private consultation room. 
The research assistant will first introduce the study using language contained in the study 
flyer. If the participant expresses verbal interest in learning more, she will administer the 
screening questionnaire during the meeting. Individuals who meet inclusion criteria will 
be invited to enroll in the study and either complete the consent process in person or set 
up a phone appointment for completion of consent procedures and baseline data 
collection. 
 
4. Outreach to individuals identified through electronic medical records - As previously 
described, potential participants will also be identified through electronic medical records at 

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the U of I Endocrinology Clinic and the U of I Family Medicine Center. Individuals thus 
identified will be sent an email (provided their email address is available in the EHR) by the 
study PI introducing the study and notifying them that a member of our research team might 
contact them in the next couple of weeks. Physicians with healthinformatics capability who 
volunteer to run an EMR search to identify eligible individuals from their existing patient 
caseload will have the option to send a bulk message to eligible individuals using the patient 
portal. A script has been created for this purpose and will include the flyer for the study as 
an attachment. The patient portal (labelled MyChart within Epic) is typically used by 
physicians to communicate with patients – no changes will be made to the portal for this 
study. This means that we will not need a study build within EPIC. Regardless we have 
completed the Epic Study Build Request to adhere with institutional procedures. The 
research assistant will then contact individuals identified through EMRs (in the order that 
they appear on the EMR list) by phone and screen them for the study's inclusion criteria. 
Individuals who meet inclusion criteria will be invited to enroll in the study. At this time, we 
will not be using the UI Health Research Registry or The New Normal for this study. 
 
 
C. Explain the proposed measures to minimize the possibility of coercion or undue influence on potential 
subjects, particularly for subjects identified in VIII.B. as being vulnerable (for example: how will you 
maximize the subject’s autonomous decision-making; what if the investigator is also the participant’s 
healthcare provider, what if the participant is enrolled in a class the investigator is teaching, what if an 
employer/employee relationship exists). 
To reduce this risk, patient participants will be told that being in the study is 
completely voluntary. They can choose to not participate in the study and they can 
discontinue their participation at any time. They will be told that choosing to not be in 
the study will not affect their legal rights, access to health care, or the quality of health 
care that they receive at the study clinic. All study-related compensation ($25-$75) has 
been kept to a reasonable amount so as not to make patients feel compelled to 
participate. Efforts will be made to ensure that participants consent to becoming 
involved in the project only after gaining a clear understanding of the study procedures 
and their rights as research participants. 
 
The clinicians who will be serving as interventionists in the study also work at two of the 
clinics where recruitment will be conducted. It must be noted that both clinicians are co- 
investigators on the study and clinical faculty in the Department of Occupational Therapy. 
Neither their clinical contracts nor their academic appointments are contingent on the 
success of this study. In other words, there is no monetary reward or incentive for recruiting 
patients into the study. 
 
The following steps will also be taken to minimize coercion during patient recruitment. These 
steps pertain to all healthcare providers who will assist with recruitment including, but not 
limited to, the study interventionists: 
1. Providers will be advised to bring up the topic of this research only at the end of their 
clinical consultation to ensure that the patient’s therapeutic needs are not compromised. 
2. Providers will be advised to remind patients that participation in the study is not obligated 
and should they decide to not participate, they will continue to receive their usual clinical 
care. 
3. Providers will be advised to remind patients that they can take 2-3 days to reflect on the 
study before making their decision. 
4. It must be noted that providers will only seek patient permission to introduce them to 
the research assistant or pass on their contact    information to the research team so they can 
receive a call from a research assistant to explain the study in detail. The actual decision to 
participate or not will be made during the in-person meeting or phone follow-up which will 
be conducted by a research assistant not connected with the patient’s clinical care 

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(therefore making it easier for patients to decline participation). 
 
 
D. Will any identifiable data obtained at recruitment, including screening data from records, be retained 
without consent from subjects who failed to qualify or declined to participate? 
No 
Yes – Describe the screening data to be retained and justify the retention of such data: Names 
and contact information will NOT be retained. For participants found ineligible and for 
those who decline to be in the study, PHI (names, email addresses, diagnoses) will be 
deleted from the spreadsheet listing potential participants identified through electronic 
medical records.  Recruitment fliers/permission slips containing   this information will be 
shredded (if submitted in hard copy) or deleted (if submitted in electronic copy) as soon 
as a potential participant is found ineligible or declines to be in the study. However, we will 
retain deidentified data on reasons for ineligibility and reasons for declining as this 
information will assist in planning of future studies. This information will be analyzed as 
frequency counts e.g. x/xx individuals contacted were ineligible as they were receiving 
regular outpatient rehabilitation services; x/xx patients declined because they reported 
being not proficient with the technology that would be needed to participate  
This 
information will be critical for planning future recruitment efforts. Please note that some 
participants might not decline at first contact. instead they might request time to think over 
their decision or might be willing to be recontacted in 2-3 weeks after they have had time to 
consider their decision. Completed screening forms of these 'undecided' participants will be 
retained for 2-3 weeks until time of recontact. At that time, if they decline, the forms will be 
destroyed immediately. 
E. Check and upload all materials that will be used for recruitment. Refer to the OPRS website for 
the Investigator Guidance: Recruitment Materials for additional information. 
No recruitment materials will be used 
X Print materials (flyer, brochure, info sheets, etc.) – Describe: Flyer 
Ad (radio, TV, etc.) – Describe: 
Letter – Describe: 
Verbal script – Describe: 
X Electronic materials (e.g., website, mass mailing, email notice) – Describe: 
recruitment email 
rSocial Media – Specify social media outlets: 
Other – Describe: 
 
X. Reasonably Anticipated Risks of the Research 
A. Identify all of the reasonably anticipated risks or discomforts that may result from participation in this 
research (actual and reasonably possible, current and future) and describe the expected frequency, 
degree of severity, and potential reversibility of those risks (if known). Remember that risks can be 
psychological, physical, social, economic, or legal. If any portion of the research involves review of 
medical records, the potential for loss of privacy or confidentiality of health information should be 
listed as a risk. 
There are five potential risks for patient participants in this study. 
1. There is a mild risk of loss of confidentiality if information about the participant 
inadvertently released through study reports. The likelihood of this risk is ongoing 
through the course of the study. This risk will be minimized through a series of 
measures we will undertake (see section below), however, if it occurs, it is not 
completely reversible. 
2. There is a mild risk for loss of anonymity if patients are inadvertently identified as 
being study participants. The likelihood of this risk is ongoing through the course of the 
study. This risk will be minimized through a series of measures we will undertake (see 
section below), however, if it occurs, it is not completely reversible. 

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3. There is a potential mild risk of coercion because patients may feel that they have to 
participate in the study to please the clinic staff and providers. This is risk is likely only 
during the recruitment phase of the study and is potentially reversible by allowing 
participants to opt out of the study at any time. 
4. There is a potential mild risk of physical and mental fatigue and some physical pain 
because patients may feel overwhelmed and tired from completing the battery of 
outcome measures and instruments. This is risk is likely only during periods when 
completing assessments with participants and is potentially reversible. 
5. There is a potential minimal risk of emotional reactions when patients express 
concerns about their functional limitations during study visits. The likelihood of this 
risk is ongoing through the course of the study but it is potentially reversible. 
 
We do not anticipate any risks for the clinician participants in this study other than 
minimal risk of losing privacy and confidentiality as they will only be providing data 
related to fidelity of intervention delivery. 
 
 
B. Describe the measures taken to minimize the risks (other than undue influence or breaches of privacy 
and/or confidentiality) listed above. Measures may include screening of subjects by qualified 
personnel, eligibility criteria, use of procedures already being used for clinical purposes, qualifications 
and experience of staff performing procedures, specialized facilities or equipment, medical or 
psychological services that may be required as a consequence of the research and frequency of 
monitoring. 
1) Measures to minimize loss of confidentiality. 
We will use the HIPPA-certified version of Zoom to conduct all treatment sessions via 
video-conference or via phone call if the participant so prefers. Clinical case notes and 
assessment data will be stored only in electronic format in password-protected files or 
folders stored on a lab computer at 1919 
W. Taylor Street, which is part of the network server of the College of Applied Health 
Sciences. Clinicians will be asked to complete notes using a standard template 
(embedded in the intervention manual). The notes will be typed into Microsoft Word 
using password-protected, UIC-issued laptops. Completed notes will be stored in a 
HIPPA-compliant UIC Box Health Folder temporarily before being transferred to a 
password-protected folder stored on a secure HIPPA-compliant sever maintained at 
UIC. 
Outcomes data will be collected in RedCap. The data will be coded and identifiers 
removed before being exported from RedCap as a CSV or SPSS file. The coded dataset 
without identifiers will be stored on a lab computer at 1919 W. Taylor Street, which is 
part of the network server of the College of Applied Health Sciences. This is essential for 
data analysis as we have appropriate statistical software installed on our lab computer. 
If a statistician from a different UIC department is added to the research team, we will 
upload the coded outcomes data to our HIPAA secured UIC Box Health Folder so the 
statistician can access it. Our outcomes database will not include patient identifiers such 
as names and addresses. Each patient in the database will be identified with a unique 
project code. Patient names, addresses, and contact information, which will be collected 
for purposes of scheduling future visits, will be recorded in a separate master list. This 
master list will distinct from the screener spreadsheet. The master list will include 
patient information and their unique project identifiers and will be stored in a separate, 
password protected file, on a secure HIPPA-compliant server maintained at UIC. Only 

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designated research personnel will have access to these files through individualized 
passwords. Once data analysis is completed the files will be destroyed. 
 
2) Measures to minimize loss of anonymity. To reduce this risk, only the PIs and key 
personnel involved in data collection and patient scheduling will have access to the 
master file which contains patient identifiers. It is anticipated that the results of this 
study will appear in scientific publications and will be presented at scientific meetings 
and community events. The research team will ensure that dissemination products do 
not include any identifying information. Quantitative findings will be summarized across 
all patients in the study and will not be presented at the individual level. 
3) Measures to minimize any risk of coercion. Patient participants will be told that being 
in the study is completely voluntary. They can choose to not participate in the study and 
they can discontinue their participation at any time. They will be told that choosing to 
not be in the study will not affect their legal rights, access to health care, or the quality of 
health care that they receive at the study clinic. All study-related compensation ($25- 
$75) has been kept to a reasonable amount so as not to make patients feel compelled to 
participate. Efforts will be made to ensure that participants consent to becoming 
involved in the project only after gaining a clear understanding of the study procedures 
and their rights as research participants. 
4) Measure to minimize physical and mental fatigue and physical pain. Patients will be 
given rest breaks as needed during completion of rest breaks and surveys. 
 
5) Measures to minimize emotional reactions. Patients will be free to not answer any 
questions that make them feel uncomfortable. Research assistants and clinicians will 
have the requisite training and expertise to counsel patients if they express emotional 
reactions. 
 
C. Describe the process for reporting any unanticipated problems to the IRB and sponsor, as applicable. 
We do not anticipate serious adverse events for participants in the proposed study. Any 
health-related events occurring as a result of study procedures will be considered an 
adverse event. Potential AEs include fatigue, mild joint pain, and mild muscle soreness. 
Adverse events will be will be graded according to the National Cancer Institute’s 
Common Toxicity Criteria II (0 = No adverse event or within normal limits; 1 = Mild, 
not requiring treatment; 2 = Moderate, resolved with treatment; 3 = Severe, resulted in 
inability to carry on normal activities and required professional medical attention; 4 = 
Life-threatening or disabling; 5 = Fatal. 
 
The principal investigator will use an adapted version of the NIA Adverse Event Form 
(https://www.nia.nih.gov/research/dgcg/clinical-research-study-investigators- 
toolbox/adverse events) to monitor any AEs. Such events will be reported immediately 
(within 24-48 hours of occurrence) to the institutional IRB and the sponsor-approved 
DSMB. 
The Adverse Event protocol will be initiated when a potential issue is observed or identified 
by the investigators and/or clinicians/interventionists. Given that this study primarily focuses 
on encouraging participants to engage in daily living tasks in their own environment [things 
they are already doing to some extent in their everyday lives], we only anticipate adverse 

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events in the 0-1 range based on the NCI criteria described above. The remote intervention is 
a counseling and education-based intervention so chances of more serious risk or injury are 
very remote. The most likely events are fatigue, pain, and mild emotional reactions. These 
will be handled in the same way as they would be during in-person treatment sessions. The 
intervening clinicians have many years of experience working with patients with physical 
disabilities and are trained to identify any signs of physical fatigue. Participants 
demonstrating signs of fatigue will be asked to take a break before continuing with the 
assessment. Part of the intervention involves training participants to monitor their own levels 
of pain and their resting heart rate. Participants will be empowered to use these skills to 
monitor their own bodily reactions and rest and stretch their joints to relieve fatigue and/or 
mild pain. In case of emotional reactions, the intervening clinicians are licensed 
occupational therapists with requisite training and experience to counsel paticipants through 
emotional reactions. 
In the rare case of a more serious adverse event (such as a fall) that occurs during a remote 
interaction, the intervening clinician will take the following steps: 
1. Assess whether the partcipant has sustained an injury and how serious it is. This will be 
done by asking the patient a series of questions to assess their mental status [e.g. What is 
your name? What city are you in? What is today’s date] and their physical status [e.g. Do 
you feel any pain? On a scale of 0-10 how would you rate your pain? Do you see any 
swelling or fresh wound? Is the wound bleeding?] 
 
2. If the injury is deemed non-serious, the clinician will advise the participant to keep any 
on things, and if they feel no better/get worse in the next 24 hours, to contact their 
primary care provider. 
3.  If the injury is deemed serious, the clinician will call 911 to get the patient immediate 
medical assistance. 
4. Report the adverse event to the principal investigator, who will inform the IRB and the 
DSMB. 
 
XI. Reasonably Anticipated Benefits of the Research 
A. Identify the potential for benefits to individual subjects, including those related to an experimental 
intervention or interaction that are available only in the context of the research. Please note that 
participation in Social and Behavioral Sciences research (such as interviews, focus groups, surveys) 
rarely presents a direct benefit to the subject. Unless a direct benefit to subjects is anticipated (such 
as an educational benefit from a new curriculum, therapeutic benefit from a new service/therapy), 
please state that no direct benefits to subjects are anticipated. 
 
As part of the experimental intervention participants will receive occupational therapy 
services at no cost. It is anticipated that many of these individuals will have little or no 
access to these services outside the context of this research study. Services delivered as 
part of the intervention will address patients’ physical functioning and occupational 
activities. If the intervention is effective, we anticipate that patients’ functional health 
will improve, as will their health-related quality of life and their experience of primary 
care services. Improved functional health might reduce burden of care for caregivers. 
There are no direct benefits for clinicians in this study. However clinicians will learn 
about the role of occupational therapy in the management of functional health. This 
knowledge might have secondary benefits for other patients. 
 
B. Indicate how the knowledge gained from the study could produce a benefit to society or to others who 

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share the same disorder or condition. 
Evidence from the proposed project will offer new insights on the effectiveness of 
embedding occupational therapy services in outpatient care settings. Currently there is 
a lack of mechanisms to monitor and address functional health in these settings. 
Patients in need of this type of care may require referrals from their Primary Care 
Providers but may be unable to follow-through with referral advice. Embedded 
occupational therapy services may increase patient access to needed care, improve 
patients’ functional abilities, and influence physicians to be more holistic in their 
treatment approach with patients with chronic health conditions. The benefits may be 
particularly significant for low income, low literacy, and underserved patient 
populations such as those served by the study clinic. These patients often have multiple 
barriers to effectively engage in recommended health and wellbeing regimens. Second, 
evidence from the proposed project will offer new insights on how best to introduce 
occupational therapy services into primary health care clinics serving vulnerable 
patient populations. Community clinics must balance complex scheduling issues, time 
limitations, high patient needs, and limited referral resources, against available space, 
patient no-show rates, patients who have multiple health problems requiring extensive 
review for a differential diagnosis, etc. Identifying ways to improve patient engagement, 
shared decision-making, and self-management has significant positive implications for 
improving clinical outcomes, patient experience of clinical care, and provider 
satisfaction. 
 
XII. Privacy and Confidentiality 
 
A. Describe the precautions taken to protect subject privacy during the initial identification of subjects, 
subject recruitment, and collection of data from the subjects (for example: what precautions will be 
taken to protect the subject from being recognized as a research subject if recruitment or data 
collection occurs in a group setting or in public?). 
1) Measures to minimize loss of confidentiality. 
We will use the HIPPA-certified version of Zoom to conduct all treatment sessions via 
video-conference or via phone call if the participant so prefers. Clinical case notes 
and assessment data will be stored only in electronic format in password-protected 
files or folders stored on a lab computer at 1919 W. Taylor Street, which is part of the 
network server of the College of Applied Health Sciences. Clinician notes will be 
stored in a UIC Box Health Folder temporarily  before being transferred to a lab 
computer. 
Our outcomes database will not include patient identifiers such as names and addresses. 
Each patient in the database will be identified with a unique project code. Patient 
names, addresses, and contact information, which will be collected for purposes of 
scheduling future visits and/or mailing gift cards, will be recorded in a separate master 
list. This master list will distinct from the screener spreadsheet. The master list will 
include patient information and their unique project identifiers and will be stored in a 
separate, password protected file, on a secure HIPPA-compliant server maintained at 
UIC. Only designated research personnel will have access to these files through 
individualized passwords. Once data analysis is completed the files will be destroyed. 
 
 
Outcomes data will be collected in RedCap. UIC Box is not a platform for collecting 
outcomes data from the standardized questionnaires and assessments that we plan to use. 

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The skip patterns and assessment item banks necessary for accurate data collection can only 
be configured in a program such as RedCap. Prior to RedCap, we would have administered 
via paper and pencil in hard copy. However, the paper and pencil format of data collection 
is obsolete and inefficient and prone to errors. 
The data in RedCap will be coded i.e. subjects will be represented by a code.  The coded 
data will be exported from RedCap as a CSV or SPSS file. The coded dataset without 
identifiers will be stored on a lab computer at 1919 W. Taylor Street, which is part of the 
network server of the College of Applied Health Sciences. This is essential for data analysis 
as we have appropriate statistical software installed on our lab computer. If a statistician 
from a different UIC department is added to the research team, we will upload the coded 
outcomes data to our HIPAA secured UIC Box Health Folder so the statistician can access 
it. 
 
Unfortunately, data cannot be analyzed within RedCap and therefore need to be exported 
for analysis using statistical software such as SAS and SPSS. Data analysis involves multiple 
steps and cannot be completed in a single session. We anticipate that after downloading the 
data into a password protected folder within our secure college server, we will need to: 
• 
Mathematically recode variables (e.g. merging two variables into one, creating summary 
scores of assessments) 
• 
Divide the dataset into two or more datasets for subgroup analyses (e.g. separate 
datasets for control and intervention participants, separate datasets for participants with 
heart disease and diabetes) 
• 
Clean datasets by deleting outliers 
• 
Run simpler analyses in SPSS and more complicated analyses in SAS 
Given the above, constantly downloading and uploading data from and into the UIC Box 
Health after every analysis session will not only be cumbersome (tens of files will need to be 
uploaded and downloaded every single time and have to re-labelled with every download 
and upload) but also carry the risk of losing data files reconfigured for analyses. Therefore 
we will download the coded dataset without identifiers to a lab computer at 1919 W. Taylor 
Street, which is part of the HIPAA compliant network server of the College of Applied 
Health Sciences. 
 
The spreadsheet containing names and contact information of eligible individuals identified 
through electronic medical records will be uploaded to a secure UIC Box Health Folder. 
Only the PI and key research personnel will have access to this spreadsheet. 
 
For participants recruited in person, the research assistant will meet with them separately 
in a private exam room or office so although others may see them together; they will not 
know if they agreed or not to research.   
 
 
2) Measures to minimize loss of anonymity. To reduce this risk, only the PIs and key 
personnel involved in data collection and patient scheduling will have access to the 
master file which contains patient identifiers. It is anticipated that the results of this 
study will appear in scientific publications and will be presented at scientific meetings 
and community events. The research team will ensure that dissemination products do 
not include any identifying information. Quantitative findings will be summarized 
across all patients in the study and will not be presented at the individual level. 
 

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B. Data Security and Management Plan 
1. Indicate the identifiable elements that will be collected and/or included in the research 
records. 
Check all that apply 
X Names 
Social Security Numbers* 
Device identifiers/Serial numbers 
X   Phone numbers 
Medical record numbers 
Web URLs 
X Street address 
Health plan numbers 
IP address numbers 
X City or state 
Account numbers 
Biometric identifiers1 
X Zip Code 
Fax numbers 
Vehicle ID numbers 
X E-mail address 
License/Certificate numbers 
Facial Photos/Images 
Financial account information (including student ID) 
All elements of dates (except year) for dates directly related to an individual; and all ages 
over 89 and all elements of dates (including year) indicative of such age 
Date of Birth 
Identifiable UIC Student Records2 
University Identification Number (UIN) 
X    Any other unique identifier - Specify: HBA1c and Systolic/Diastolic blood 
pressure readings AFTER obtaining consent from participants. For treatment 
group participants we will record these parameters from their last visit with PCP 
before the intervention and closest visit with the PCP after the intervention. For 
participants in the control group, we will use the information that is available in 
their medical records from the last available record before the date of completing 
the baseline surveys and assessments, and the next available record 
approximately 10 weeks after the date that they complete the baseline surveys 
and assessments.  
 
None of the identifiers listed above – Skip to item C 
 
1 Biometric Identifiers are observable biological characteristics which could be used to identify an individual, 
e.g., fingerprints, iris/retina patterns, and facial patterns. 
2 Documentation of approval from the Registrar must be submitted unless prospective signed consent is 
obtained from the student or guardian. 
*NOTE: If social security numbers will be collected, explain below why they are necessary 
and how they will be used: 
 
2. Data Collection and Storage 
a. Identify what methods you will use to collect and store data: 
  Internet-based application/package – Specify: 
REDCap [define host X CCTS/IHRP 
Other (define): 
] 
UIC ACCC Qualtrics 
UIC Box 
UIC Box Health Data Folder (for research involving PHI) 
*Survey Monkey or other commercial survey service – Specify: 
*Other - A thorough description of the characteristics of the application/tool must be 
provided. This description should address the following elements if applicable: 
product/tool name, host, security measures, encryption mechanism, and how collected 
data is maintained and stored by the application/tool. 
Non-internet based application (i.e. directly on a desktop/laptop). 
Paper 
Recording Media - 
Photo 
Video 
Audio 
Specify how the data will be stored and how participants will be identified in the recordings: 
 
Subject Artifacts (such as classroom assignments, regular work products, lesson plans) 
Stored specimens 
Other: 

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b. Describe whether and how social media platforms (e.g., Facebook, Twitter, Snapchat, etc.) will 
be used to collect data and/or communicate with subjects: 
  Not applicable 
 
 
 
 
3. Data Security 
a. Describe how all types of data as selected above will be secured. 
i. 
  Indirectly with a code linked to the identity of the subject. 
Describe the coding method, specify who will have access to the code/master key, 
indicate where the key is stored, and explain how it will be protected against unauthorized 
access: Participants who enroll in the study will be assigned a numeric code in the 
outcome database in RedCap i.e. outcome data from REDCap will be identified by a 
code.  The master list including the participants' names, contact information, and 
corresponding numeric codes will be stored separately from the research data. The 
master list will be saved as a Microsoft Excel spreadsheet on the secure network 
server of the College of Applied Health Sciences. The file will be password 
protected and only the PI, Dr. Mirza and key research personnel, will have access to 
the password. Hard copies of permission flyers completed by participants who are 
screened eligible and agree to be in the study will be stored in locked filing cabinets 
in the PI’s locked research lab. Only the PI, Dr. Mirza and key research personnel, 
will have access to the cabinet. 
PHI collected post enrollment and POST CONSENT will include the following variables – BP and 
HBA1c reading [for treatment group participants – at last visit with PCP before the intervention and 
closest visit with the PCP after the intervention. For control group participants - last time tested 
before completing the baseline surveys and assessments, and the next available record 
approximately 10 weeks.] These data will be stored in the RedCap outcome database where 
subjects will be identified by a code. Note that dates of readings will not be recorded. We will 
record these variables as ‘preBP’, ‘postBP. ‘preglucose’ and ‘postglucose’. After data collections is 
completed the coded outcomes data with identifiers removed will be exported from RedCap as a 
CSV or SPSS file. The coded dataset without identifiers will be stored on a lab computer at 1919 
W. Taylor Street, which is part of the network server of the College of Applied Health Sciences. 
 
ii. 
x Directly, personal or private identifiers (identifiable elements) are maintained with 
the data. 
Justify the inclusion of direct subject identifiers, and indicate who will have access to the 
data: 
PHI collected at recruitment, pre-enrollment AND BEFORE CONSENT will only include the 
following variables – potential subject’s name, email, phone number, primary diagnosis (diabetes 
or heart disease). This information will be for recruitment purposes only and will be stored in the 
protected UIC Box health folder only. Only designated key personnel will have access to it. 
 
 
 Limited Data Set [Protected Health Information (PHI) subject to the Privacy Rule that 
includes elements limited to city, state, ZIP Code, elements of date, and other numbers, 
characteristics, or codes not considered as direct identifiers]. Requires a Data Use 
*Note: Any investigator who uses external survey software other than REDCap, UIC ACCC Qualtrics, or 
UIC Box Health Data Folder for collecting and maintaining UIC/UI Health PHI and/or personal data from 
individuals physically located in the European Union Economic Area (EEA) must provide evidence of a 
business associate agreement between the University and the external survey software provider. For 
more information, refer to the UIC HSPP policy Research Data Security. Please visit the OPRS website 
or contact OPRS at uicirb@uic.edu for more information regarding data collected in the EEA and the 
European Union General Data Protections Regulation (EU GDPR). 

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Agreement.  
 
 
 
 
b. Indicate the method(s) used to secure each data type. 
Password access 
Portable devices – Specify encryption software (required): Data Protection (in-built 
within Apple iPad) 
Encryption software will be used – Specify encryption software: 
  Secure network server will be used – Specify secure server: College of Applied 
Health Sciences 
Stand alone desktop/laptop computer will be used to store data 
Not connected to server/internet 
An organization outside of the UIC will store the code key. 
X Locked file cabinet 
Locked office/lab. 
Locked office suite. 
Locked refrigerator/freezer 
 X    Other - Specify: HIPAA compliant UIC Box Health Folder 
 
c. Indicate when identifiers (including the master list) will be removed or destroyed. 
End of data collection 
End of data analysis 
Post publication/dissertation defense 
Other – Specify: 
 
4. Data Sharing 
 
a. Will the data or specimens be shared with persons other than UIC investigators and research 
staff noted on the protocol application and Appendix P? 
  No – Skip to item C.1. 
Yes – Specify with whom the data will be shared: 
 
b. Indicate the manner in which the data will be shared: 
As a de-identified dataset – Skip to item C.1. 
With direct identifiers 
With indirect identifiers (i.e., coded dataset) and/or Limited Data Set 
Identify who will have access to the code key or master list: 
 
c. Specify how identifiable data will be transferred: 
Non-electronic transfer (hard copy or physical specimens) – Specify: 
Transmitted over a secure network – Specify network: 
Via UIC e-mail - Specify encryption: 
Cloud based data sharing program (UIC Box Health Data Folder is the only approved 
method of sharing PHI in this manner) 
Specify: 
Other - Specify: 
Please note: 
- Items i and ii require consent and/or authorization (if PHI is involved) from the subject or a Waiver of 
Consent and/or Waiver of Authorization (if PHI is involved) from the IRB. 
- UIC and/or outside agencies may require the use of a data use/data transfer agreement that outlines 
the procedures necessary to protect identifiable or coded data that will be transferred or shared 
between agencies. You must contact the Office of Sponsored Programs (OSP) at 312-996-2862 or 
awards@uic.edu for additional information and direction. 

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C. 1. Does the research protocol have a data and safety monitoring plan? For more information refer to 
UIC OPRS HSPP policy Data and Safety Monitoring Plans (DSMPs), Data and Safety Monitoring 
Boards (DSMBs), and Data Monitoring Committees (DMCs). 
Not Applicable. – Skip to item D as all of the following criteria are met: 
• research is minimal risk, 
• research does not involve physical or therapeutic intervention with subjects, 
• subject trauma or distress is not an anticipated risk, and 
• the sponsor does not require a monitoring plan. 
  Yes – Describe the plan: The Principal Investigator (PI) will be responsible for 
ensuring participants’ safety on a daily basis. A local DSMB has been established. 
The Chair of the DSMB will serve in the capacity of Safety Officer, The Data and 
Safety Monitoring Board (DSMB) will act in an advisory capacity to the NIA 
Director to monitor participant safety, evaluate the progress of the study, to 
review procedures for maintaining the confidentiality of data, the quality of data 
collection, management, and analyses. 
 
A minimum of two annual meetings will be scheduled between the research team and 
the DSMB. Meetings will occur via teleconference, web conference or in-person 
per the convenience of DSMB members. The first meeting will focus on updating 
the DSMB about study progress and issues related to participant safety. The 
second meeting will focus on reviewing data quality and management. Reports 
summarizing safety issues, study progress, and data management will be 
submitted to the DSMB twice a year. 
 
The content of the report will include projected timeline and schedule, summary of 
changes (if an to study protocol), enrollment status (including reasons for 
ineligibility and participation refusal), demographic characteristics of recruited 
participants, treatment adherence and completion, and incidence of adverse events 
and their resolution. 
 
2. Is this a multi-center trial AND UIC is the lead site or serving as the data coordinating center? 
Yes – Plans for managing and communicating the unanticipated problems involving risks to 
subjects or others, interim results, and protocol revisions among the multiple sites are 
described within the uploaded protocol OR explain: 
  No 
 
 
D. Will you be applying for a Certificate of Confidentiality? Research funded by NIH that involves 
sensitive, identifiable data will be automatically granted a Certificate of Confidentiality. Ensure the 
consent document includes the appropriate language. 
No 
Yes – Include the required template language in the consent document and refer to the Guidance 
for Investigators: Certificates of Confidentiality for more information regarding the 
submission process and regulatory requirements. 
 
E. 
Is this research being funded by the National Institute of Justice? 
No 
Yes – The investigator is responsible for the following: 
- 
Uploading the NIJ Privacy Certificate 
- 
Ensuring the proposal indicates that a copy of all data must be de-identified and sent 
to the National Archive of Criminal Justice Data, including copies of the consent 
document, data collection instruments, surveys, or other relevant research materials 

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- 
Ensuring the Informed Consent Document(s) include: 
o 
NIJ approved Privacy Certificate language 
o 
De-identifiable information will be sent to the National Archives of Criminal 
Justice Data 
o 
A statement indicating that if a subject is a danger to themselves or others, it will 
be reported to the authorities 
o 
A statement indicating that communicable diseases (TB, HIV) will be reported to 
the state and/or federal public health authorities 
o 
Statement that current or past domestic, child, or elder abuse is not reportable 
Refer to the Additional Informed Consent Template Language and the Guidance for Investigators 
Informed Consent for additional information. 
 
XIII. Compensation & Costs 
 
 
 
A. 1. Will subjects receive any compensation (for example: money, gifts, or gift certificates) directly 
related to research participation? If subjects will be entered into a lottery, select “No” and skip to 
item B. 
No – Skip to item B. 
Yes - Indicate the type of compensation. 
  Monetary (total amount: $90) 
Non-Monetary 
Both 
 
2. Describe in detail: 
 
a) How compensation will be prorated (e.g., $x for each visit, $y for subjects who do not qualify 
after screening visit, etc.): Participants will receive a Target gift card worth $30 for 
completing all surveys and assessments at the beginning of the study and a 
Target gift card worth $40 for completing all follow- up surveys and 
assessments. This amounts to a total of $70 for completing the study. 
Participants who do not complete the study will be compensated for the portion 
they have completed. In addition, participants will received $10 to offset parking 
and transportation costs for attending the two in-person sessions. No 
identifiable subject contact information will have to be shared with the 3rd 
party for payment processing 
b) When compensation will be provided (e.g., after each visit, at the completion of all visits, 6-8 
weeks after the completion of all visits due to processing of check, etc.) and in what format 
(e.g., cash, check, VISA gift card, etc.): We will send the first $30 gift card by postal 
mail within approximately one week after each participant completes all 
surveys and assessments at the beginning of the study. We will send the second 
$40 gift card  by postal mail within approximately one week after the 
participant completes all surveys and assessments at the end of the study. 
Participants will be paid for transportation/parking in cash at the end of the in-
person visit. 
B. Will subjects be entered into a lottery for compensation (for example: money, gifts, or gift certificates) 
before, during, or after participation in the study? 
No 
Payment in exchange for referrals of potential participants (finder’s fee) and payments designed to 
encourage or accelerate recruitment by being tied to the rate or timing of enrollment (bonus payment) are 
generally unacceptable. 

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Yes - 
a. Provide a justification for conducting a lottery rather than compensation per subject: 
b. Indicate the type of compensation: 
c. Indicate the odds of winning the lottery: 
d. Indicate when the winner will be notified and receive the compensation: 
 
C. Does this study provide payments in exchange for referrals of potential participants (finder’s fees) or 
payments designed to encourage or accelerate recruitment by being tied to the rate or timing of 
enrollment (bonus payment)? 
No 
Yes – Describe: 
 
D. Are subjects or their insurance/third-party payer responsible for any research-related costs? 
No 
Yes – Complete items a and b: 
a. List the procedures/expenses: 
 
b. Provide a justification as to why research-related expenses are not being covered by 
the research. 
 
 
XIV. Procedures to Obtain Informed Consent/Assent 
A. Indicate the type(s) of consent you will obtain: 
Written 
Verbal 
Waiver of Informed Consent and/or Waiver of Signed Consent 
 
B. Indicate who will obtain informed consent from potential subjects. 
PI 
Co-investigators 
Research coordinators/Others as delegated 
 
 
C. Indicate where and when informed consent will be obtained from potential subjects. 
We are requesting a waiver of consent for recruitment purposes. We will secure 
written, signed consent before study enrollment The research assistant will be trained 
by the PI with special attention to assessing participants’ capacity for consent. An 
assessment script has been developed for this purpose. During the consent process, 
potential participants will be periodically asked questions to ascertain their capacity 
for consent (e.g. In your own words, can you describe the risks of participating in this 
study? What happens if you change your mind about participating?). If the 
participant answers accurately, the research assistant will continue with the consent 
process. If answers are inaccurate, the participant will be deemed ineligible for the 
study. In addition, the Short Orientation Memory Concentration Test (SOMCT) will 
be used during the screening process to ensure the participant is eligible for the 
study. A score of 0-8 on this test indicates normal to minimal impairment. Any one 
with a score>8 will be considered ineligible. 
 
Informed consent will be obtained both in person and remotely. Participants who are 
recruited in person at one of the study clinics will be asked if they have time to complete 
the screening questionnaire and the consent process rightaway. Participants will be given 
one signed hard copy of the form for their records while the research assistant will retain 

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the second copy, which will be later (after the clinic schedule is over and on the same day) 
stored in a locked cabinet in the PI’s research laboratory. 
 
For participants who are recruited remotely and screened by phone, the research assistant 
will ask if they are willing to complete the consent process during the same phonecall or if 
they’d like to schedule a separate phonecall for explaining the consent form by phone 
before baseline data collection begins. Either way, the research assistant will explain the 
consent form in detail and explain that they can sign the form on a separate and secure 
platform. We will use UIC REDCap hosted by CCTS/IHRP fpr this purpose. We will set 
up an e-consent survey in RedCap. The e-consent survey form will be sent to each 
participant by email using a unique survey link so that the response status and follow-up 
can be done using the individually linked information. This email will be sent by the 
research assistant through an encrypted email via Microsoft Outlook. When the 
participant clicks on the link, they will be asked to authenticate themselves using a pre-
agreed password. The password will be agreed upon by the research assistant and 
participant over the phone right before the email link is sent. When the e-consent 
framework is setup, at the end of consent form participant will be asked to certify the 
information before clicking ‘submit’ under this statement - “I understand that clicking 
submit will electronically sign the form ad signing this form electronically is the equivalent 
of signing a physical form.” They will also be able to download a PDF copy of the form. 
 
 
 
D. Does the potential exist for enrolling subjects (or subjects’ LARs) who do not understand English? 
No 
Yes – Describe how the consent process will be conducted (e.g., who will convey information to 
the subject or LAR in a language they understand, whether the consent will be 
documented using a translated consent form or short form). 
 
 
 
E. Will any portion of the research involve deception? 
No 
Yes - Upload Appendix J and a debriefing statement with this application. 
 
XV. HIPAA Compliance 
A. 
Does your research use and/or disclose Protected Health Information (PHI)*? 
No – Skip this section. 
X Yes 
For information about the involvement of non-English speaking subjects in research, including use of 
the short form, please refer to the Guidance: Involvement of Non-English Speaking Subjects in 
Research at the University of Illinois at Chicago. 

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*Data is considered to represent PHI when an individual’s health information, including billing records, 
contains or is linked to one of the identifiers listed in #XII.B.1. For example, health-related information 
is considered PHI if any of the following are true: 
•
The researcher obtains the information directly from a provider, billing records, health plan, health 
clearinghouse or employer (other than records relating solely to employment status); 
•
The records were created by any of the entities listed above and the researcher obtains the 
records from an intermediate source which is NOT a school record or an employer record related 
solely to employment status; OR 
•
The researcher obtains it directly from the study subject in the course of providing treatment to 
the subject. 
 
Health-related information is not considered PHI if the researcher obtains it from: 
•
Student records maintained by a school; 

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B. 
Will PHI be used for the purposes of identifying and/or recruiting potential subjects for the research? 
No 
X Yes 
 
C. 
Will subjects be selected from records outside the UI Health System? 
No 
Yes – Indicate who gave approval for the use of the records: 
• 
Upload the protocol, consent documents, letters, etc., for securing consent of the 
subjects for the use of the records if the records are "private" medical or student records. 
• 
Upload written documentation for cooperation/permission from the institutional holder or 
custodian of the records. 
 
D. Will any research related information be put into the health information records or any other 
permanent record of the subject? 
  No Clinical case notes, blood pressure readings, and HBA1c readings are the only PHI that 
will be used in this study. These case notes will be collected solely for monitoring fidelity of the 
intervention. These notes will NOT be put into the health information records or any other 
permanent record of the subject. Blood pressure and HBA1c readings will be retrieved from EHRs, 
AFTER obtaining consent from patients; no information will be added to patient records. 
Yes - Explain: 
•
Employee records maintained by an employer related to employment status; OR 
•
The research subject directly, if the research does NOT involve treatment.