Empathy in Action: Sunshine Calls for Life With Diabetes
Phase: NA
Conditions: Diabetes Mellitus, Type 2, Diabetes, Mental Health, Health Behavior
Sponsor: University of Texas at Austin

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Official Title of the study:  
Empathy in Action: Sunshine Calls for Life With Diabetes  
 
NCT number:  
NCT05173675  
 
Date of the document:  
November 23, 2021  
 
Updated version:  
January 6, 2023 
 
Unique Protocol ID:  
STUDY00001571 
 
 
 

Page 2 of 32 
 
 
FORM: IRB Proposal - Standard Submission 
NUMBER 
VERSION DATE 
HRP-UT901 
04/29/2021 
 
GENERAL STUDY INFORMATION 
 
Use for greater than minimal risk studies and minimal risk studies that fit into one or more expedited categories (see 
Section 5.3 of our Policies & Procedures  for details regarding expedited research). 
 
Do NOT submit this form if the study will qualify for exempt review, instead submit HRP-UT902 IRB Proposal – Exempt 
Submission Form found in the document Library.  
 
If you are only using secondary data that will not be initially collected solely for this research project, use HRP-UT903 
Template IRB Proposal Secondary Use form instead. 
 
For studies following a multi-center or sponsor protocol, please use this guidance to assist in your completion of this 
form. 
 
For questions regarding definitions, policies, or terms referenced below see the policies and procedures manual. 
 
Please note, Word online does not support Word checkboxes. Please download the file and use your desktop version of 
Microsoft Word. 
 
1 
Review Type (Choose one) 
 
Click on the check box (or double click and type an “X” if using Google Docs) the one review type that applies.  
 
Please note: Expedited Review does not refer to the timeliness of the review of your protocol, but specific 
categories of research defined by ORHP. If you would like help determining which type of review is most 
appropriate for your study please contact the Office of Research Support and Compliance:  
https://research.utexas.edu/ors/about-ors/contact-us/. 
 
a ☐ 
 
Full Board Review – Greater than Minimal Risk Research 
b ☒ 
 
Expedited Review – Minimal Risk Research  
 
2 
Research Hypothesis 
To input text, click in the light grey area below. 
 
A program of empathetic and relationship-oriented telephone calls by lightly trained lay 
persons can support diabetes self-management behaviors and reduce Hemoglobin A1C 
in diabetic patients of a federally qualified health center (FQHC). 
 
 
 

Page 3 of 32 
 
3 
Study Background 
To input text, click in the light grey area below. 
 
 
Mental health issues affect an individual’s ability to manage chronic health conditions 
such as diabetes (Chaoyang et al 2008; Schmitt et al 2021). In self-management 
programs for diabetes, when mental health is addressed it is usually secondary to more 
tactical self-management steps such as goal-setting and providing connection to 
resources.  In this study we will assess a mental-health-first approach to supporting 
diabetes self-management through a program of empathetic telephone calls, delivered 
by lightly-trained lay people.  The program builds on the success of a previously tested 
4-week long empathetic telephone call program that found significant and sizeable 
reductions in depression, anxiety and general mental health (Kahlon et al 2021). 
 
Prior work has shown that telephone-based diabetes education and support programs 
can significantly improve Hemoglobin A1C management, reducing levels in low income 
diverse communities. A program of 8 telephone calls over 12 months implemented in 
the Bronx, NY focusing primarily on medication adherence and secondarily on nutrition 
and exercise support achieved significant reductions of 0.8% relative to controls for 
those who began the program with A1C levels above 9% (Chamani et al 2015)  A follow-
up analysis showed that the intervention reduced hospitalization over the following 
three years (Tahbaei et al 2020). 
 
In this study we will use a randomized controlled trial to assess the impact of a 6-month 
long intervention of empathetic relationship building engagement with emotional and 
motivational support delivered telephonically for patients with diabetes at a Federally 
Qualified Health Center (FQHC). Telephone callers, lay people with light training on how 
to be empathetic and engaging in calls, will support participants’ journeys on their own 
goals related to nutrition, exercise, sleep and medication adherence.  They will not 
provide diabetes specific information, instead they will support people walking more, 
sleeping better, eating better and taking their medications. The impact of the program 
will be assessed primarily on Hemoglobin A1C levels and secondarily on depression and 
mental health at the end of the 6-month intervention, and in the following 6 months. 
Results will be compared to patients in the control arm that receive usual care. 
Participants will be recruited from our partner, an FQHC, Lone Star Circle of Care (LSCC) 
and include patients with Hemoglobin A1C of greater than 8.0 as measured at any point 
in the 12 months preceding enrollment. 
 
• Chaoyang Li, Earl S. Ford, Tara W. Strine, Ali H. Mokdad. Prevalence of Depression Among U.S. 
Adults With Diabetes  Diabetes Care Jan 2008, 31 (1) 105-107; DOI: 10.2337/dc07-1154 
• Kahlon MK, Aksan N, Aubrey R, et al. Effect of Layperson-Delivered, Empathy-Focused Program 
of Telephone Calls on Loneliness, Depression, and Anxiety Among Adults During the COVID-19 

Page 4 of 32 
 
Pandemic: A Randomized Clinical Trial. JAMA Psychiatry. 2021;78(6):616–622. 
doi:10.1001/jamapsychiatry.2021.0113 
• Schmitt, A., Bendig, E., Baumeister, H., Hermanns, N., & Kulzer, B. (2021). Associations of 
depression and diabetes distress with self-management behavior and glycemic control. Health 
Psychology, 40(2), 113–124. https://doi.org/10.1037/hea0001037 
• Impact of a Telephonic Intervention to Improve Diabetes Control on Health Care Utilization and 
Cost for Adults in South Bronx, New York 
• Bahman P. Tabaei, Renata E. Howland, Jeffrey S. Gonzalez, Shadi Chamany, Elizabeth A. Walker, 
Clyde B. Schechter, Winfred Y. Wu Impact of a Telephonic Intervention to Improve Diabetes 
Control on Health Care Utilization and Cost for Adults in South Bronx, New York.  Diabetes Care 
Apr 2020, 43 (4) 743-750; DOI: 10.2337/dc19-0954 
 
 
4 
Design and Methodology 
 
Provide information regarding study design or data collection methodologies. Details regarding protocol specific 
research procedures will be discussed in a later section. 
 
To input text, click in the light grey area below. 
 
Design: Randomized controlled trial. 
Population: Adults with Hemoglobin A1C >8.0 measured at any point in the 12 months 
prior to enrollment, who have had at least one visit (Family medicine, behavioral health 
or other) with Lone Star Circle of Care within the past 12 months (in person or 
telehealth) 
Randomization: Consented participants will be randomized to the intervention or 
control arm in a 1:1 ratio. 
Blinding: Research staff involved in taking biomedical measurements will be blinded to 
participant status.  Participants will complete surveys in person using a tablet or 
individual paper copy, thus research associates will remain blinded. 
Time period: The study is divided into two parts.  
• Phase 1 (6 months) is a randomized controlled trial testing the effect of telephone 
call-based empathetic engagement supported by caller-customized letters, 
together with small self-selected incentives (health tool) and caller-selected 
personal recognitions (small gifts selected based on the callers understanding of 
the participant), and low-literacy basic diabetes self-management information, 
against usual care.  The primary outcome is Hemoglobin A1C (A1C) with repeated 
measures at baseline, 3 and 6 months.    
• Phase 2 (subsequent 6 months) is the follow-up phase allowing us to estimate the 
12 month longer term trajectory of A1C in Intervention and Control. To maximize 
the utility of the study to inform the most effective program design, participants 
in the control arm will receive the same opportunity to self-select health tool as 
the intervention arm received in Phase 1, but will make the choice during the 6 

Page 5 of 32 
 
month survey collection. The material portion of the recognition/gifts, which 
(gift), will also be selected at the 6-month survey, but instead of being selected by 
the caller, the participant will select their own gift from the same set used by the 
callers in Phase 1. The control arm will also receive the low-literacy basic diabetes 
self-management information during Phase 2. All items will be provided to the 
control arm in Phase 2 on the similar schedule as intervention participants 
received them in Phase 1. As a result, we hope to estimate the impact of the 
small incentives and basic diabetes self-management information without the 
communication elements, telephone call-based empathetic engagement and 
customized newsletters, by comparing the results in the Intervention arm in 
Phase 1, with those in the Control arm in Phase 2.  
 
 
Overview: 
 
 
 
Intervention: Participants in the intervention arm receive - 
• Incentives & personal recognitions  
• Small Health-promoting Incentive: 
o Choice of a health-promoting tool offered by the caller in the first week of 
the program.  A choice will be provided by the caller between a pedometer 
and a smart weigh scale of equivalent value. If neither of these options are 
applicable based on health or other limitations, back-up options will be 
offered to them (fitness resistant bands or exercise program for upper 
body fitness). The health-promoting tool will be mailed to participants by 
approximately the 5th week of the program. 
• Personalized recognition of participant by caller (“Personal recognition/Gift”): 
o Callers will select, based on their understanding of the participant, 2 items 
from a larger pre-selected set of health-related items (related to cooking, 
A. Assess effect of integration of small 
incentives + phone calls (“Program”) 
against usual care: Randomized 
Controlled Trial in Phase 1
B. Estimate effect of phone calls alone: 
Intervention Phase 1 versus Control 
Phase 2.
C. Estimate Pre-Post changes in 
Intervention over 12 months (provides 
clues to sustainability) and control 
separately.
Phase 2.
Phase 1.
0 months
12 months
3
6
9
INTERVENTION
•Basic diabetes mgt info.
•Incentive, Recognitions
•Relational phone calls + letters
CONTROL
•
Usual Care
INTERVENTION ARM
•
Monthly text msg reminders
CONTROL ARM
•Basic diabetes mgt info.
•Material portion of Incentives, 
Recognitions
A.
C.
C.
B.

Page 6 of 32 
 
physical activity or sleep), each of equivalent ~$25.00 value. Callers will 
select and the program will mail items to the participants between months 
1 and 5, to ensure the second item is received within 6 months (Phase 1).  
Callers will have a deadline to send the first item by the middle of the third 
month (Month 2.5) and by the middle of the 5th month (Month 4.5)    
• Diabetes management information (print) geared to people with low-literacy 
(Diabetes management materials). This information will be mailed to intervention 
participants after randomization.  
• Communications to support and celebrate the participants learnings: 
o Relationship-building empathetic telephone calls between lay caller and 
participant. Calls provide an opportunity for participants to discuss 
whatever they wish to share, and provide support for participants’ goals for 
exercise, nutrition, sleep and medication adherence. In the course of 
engagement, if the caller feels like the participant can benefit from 
checking in with their regular clinic provider, they may suggest doing so. In 
addition, if a participant mentions a social need (such as transportation, 
food, housing), the caller may suggest some potential social resources for 
the participant to call. In addition, if the caller feels the participant could 
benefit from a pre-selected list of YouTube videos, that includes people 
talking about their life with diabetes, the caller may decide to share it with 
them. Calls occur 3X a week in first month and 1X a week in subsequent 
months for 6 months. Participants have agency in informing some aspects 
of how frequently they’re called.  After the first week they can adjust calls 
to a maximum of 5X a week or down to 2X a week (minimum of 2X/week 
for the first month). After the fourth week all calls shift to weekly.  After 
the 8th week they can adjust calls to 2X every 4 weeks or stay on weekly 
schedule.  Calls average 10 minutes per call or less.  The participant may 
also receive communication via text message about their upcoming phone 
calls. 
o A letter sent twice in 6 months (Phase 1) to all participants in a callers 
panel of participants that reflect learnings from participants themselves. 
No identifiable information will be in these letters. 
o Automated Monthly text messages during months 7-12 (the follow-up 
phase) with pre-filled customized communications prepared by their caller 
as simple reminders of tips they discussed during the first 6 months. 
Control: Participants in the control arm receive –  
• Material aspects of elements from the Intervention arm: 
• Diabetes management information for people with low literacy (print) at the start 
of phase 2 (after the 6 month assessment). 
• Small health-promoting incentive: 

Page 7 of 32 
 
o Choice of a health-promoting tool offered as one of the final questions of 
the 6 month assessment. A choice will be provided at the end of the 6 
month surveys between a pedometer and a smart weigh scale of 
equivalent value. If neither of these options are applicable based on health 
or other limitations, back-up options will be offered to them (fitness 
resistant bands or exercise program for upper body fitness). The tool will 
be mailed within the 7th month. 
o A choice 2 items from the same set of items used for the Intervention arm 
in Phase 1 related to healthier living, each <$25/-. This will be offered as 
one of the final questions of the 6 month assessment. The selected items 
will be mailed out to the participant in the 8th month and 10th month.  
• Participants in the control arm do not receive the communications elements, 
telephone calls or letters, and otherwise continue with their normal standard of 
care. 
• Participants in the control arm do not receive any text messaging reminders 
related to the program. To prevent loss to follow-up in the control arm, we will  
send research study reminder text messages about upcoming measurement 
appointments. 
 
Measures: Primary outcome is Hemoglobin A1C at 6 months (repeated measures at 3 
and 6, 9 and 12 months).  The measurements will be taken at Lone Star clinic sites, Dell 
Medical School at The University of Texas at Austin, or other community-based sites, by 
a member of the research team.  Secondary outcomes include Blood pressure through 
direct measurement and self-reported depression (PHQ-9), anxiety (GAD-7), general 
mental and physical health (SF-12) and self-reported healthcare utilization and will also 
be measured at Lone Star clinic sites, Dell Medical School at The University of Texas at 
Austin, or other community-based sites, by a member of the research team.  In 
addition, process measures include measurements directly from the telephone call 
system: calls placed/attempted; calls connected (someone spoke); call duration. See 
below for table of all measures and method of collection. 
Measure Collection: Biomedical measures will be directly collected in person at their 
clinic site, Dell Medical School at The University of Texas at Austin, or a community site 
that is convenient (A1C and Blood pressure). Patient-reported measures will be 
collected through self-report on a tablet (or paper copy if participant chooses) at the 
same time biomedical measures are collected. Electronic Health Record measures will 
be collected via a data agreement with Lone Star Circle of Care (LSCC). 
 
Measure 
Freq 
Tool 
Program Effects 
  
  
Hemoglobin A1C 
Baseline/3 mths/6 mths/9 mths/12mths 
Finger stick on portable device 

Page 8 of 32 
 
Blood Pressure 
Baseline/3 mths/6 mths/9 mths/12mths 
Automatic blood pressure cuff 
Depression 
Baseline/3 mths/6 mths/9mths/12 mths 
PHQ-9 
Anxiety 
Baseline/3 mths/6 mths/9 mths/12 mths 
GAD-7 
General Health 
Baseline/3 mths/6 mths/9 mths/12 mths 
SF-12 
Healthcare Utilization (PCP & BH 
clinic, Hosp, ED visits) 
Baseline/3 mths/6 mths/9 mths/12 mths 
Customized (4 new questions 
added) 
Healthcare Utilization (PCP visits, 
BH visits) 
Data pulls for data collected during program 
LSCC ElecHealthRecord 
Medication Related to DM and HTN 
Baseline/3 mths/6 mths/9 mths/12mths 
Customized 
Medication Adherence Survey 
Baseline/3 mths/6 mths/9 mths12 mths 
Med Adherence Report Scale 
(MARS 5) 
Diabetes Self-Management 
Baseline/3 mths/6 mths/9 mths/12 mths 
Perceived Diabetes Self-
Management Scale (PDSMS) 
Diabetes Self Care 
Baseline/3 mths/6 mths/9 mths/12 mths 
Summary of Diabetes Self-Care 
Activities (SDSCA) 
Diabetes Self Efficacy 
Baseline/3 mths/6 mths/9 mths/12 mths 
Stanford Self-Efficacy for Diabetes 
Scale 
Diabetes Distress 
Baseline/3 mths/6 mths/9 mths/12 mths 
Diabetes Distress Screening Scale 
Loneliness  
Baseline/3 mths/6 mths/9 mths/12 mths  
UCLA 3-item Loneliness Scale 
Onset Date of Diabetes  
Baseline 
Customized 
Social Needs Survey 
Baseline/6 mths/12 mths 
Adapted from PRAPARE 
Social Support 
Baseline 
Lubben Social Network scale 
Participant Demographics 
Baseline 
Customized 
Household demographics 
Baseline 
Customized 
Interest in Calling Others 
6 mths 
Customized 
Program Satisfaction 
6 mths (intervention arm only) 
Customized 
Program Improvement  
12 mths (intervention arm only)  
Customized  
Program Implementation 
  
  
Call Occurrence 
Continuous (daily; did it happen) 
Twilio report 
Call Connection 
Continuous (daily; did the call connect to a 
person) 
Twilio report 
Call Duration 
Continuous (daily); for every call placed, 
duration 
Twilio report 
Intracall dynamics 
Continuous 
Analysis of real-time audio 
streams 
 
 
 
5 
Data Analysis 
Describe the data analysis plan, including any statistical procedures or power analysis. 
 
To input text, click in the light grey area below. 
 
Our primary outcome of interest is Hemoglobin A1C.  However, the approach being used is modeled after a 
successful mental health intervention (Kahlon et al 2021) which showed depression can be improved with the 
type of empathy calls utilized in the current study.   
 
To ensure that the effect of the empathy calls program on A1c can be assessed without confounding it with 
depressive mood in the first 6-month phase-I portion, we will rely on stratified randomization so that 

Page 9 of 32 
 
approximately 50% (N=75) of the individuals in both the control and experimental group have a PHQ9 ≥5 at 
baseline and 50% of the individuals have PHQ9 <5 at baseline. With 150 individuals in each arm, three 
assessments for A1c, the primary outcome, and depression (PHQ9), secondary outcome, we have 80% statistical 
power with alpha = .05 to detect effects as small as f = .09, which is a small, standardized effect size, and have 
90% power to detect effects as small as f = .10, also a small effect size, assuming only a moderate correlation for 
rank-order stability across time for each outcome of r = .30. This correlation is reasonable for A1c and is an 
underestimate for the typical correlation for PHQ9. Statistical power for the effect of interest increases as these 
correlations in the outcome measures goes up. Regarding correlations, we have 90% power to detect 
correlations as small as r = .26 and 80% power to detect correlations as small as r = .23 within each group (N = 
150) at alpha = .05. These are fair to moderate effect sizes that bear on the power of any follow-up mediation 
analyses.  
 
We will test differences in the trajectory of A1c over the course of six-months with three assessments (baseline, 
3- and 6-months) for those who receive empathy calls to support diabetes self-management versus those who 
do not receive these support calls.  We will rely on linear mixed effect regressions with random terms to model 
individual differences in both the intercept and change terms, accounting for the clustering effect of shared 
lightly trained callers. We will predict these trajectories using the following person-level covariates: grouping 
indicator, terms to capture diabetic treatment type and dose, change in PHQ9 from baseline to 6-month 
depression. The cross-level interaction of grouping indicator with time will constitute the effect of interest. In 
addition, if change in depression predicts the person-specific slopes for A1c and does so more strongly for those 
in the intervention than control group, we would have evidence that depression management affects A1c 
course. Similar models will be constructed for the secondary outcome of depression, PHQ9 across three waves 
of data collection, with frequency/duration of support calls across those waves modeled as a time-varying 
covariate. Person-level covariates will include grouping indicator, terms to capture change in A1c from baseline 
to 6-months. If change in A1c predicts person-specific slopes for depression and does so more strongly for those 
in the intervention than control, we would have preliminary evidence that improved control of A1c affects 
course of depression, an unlikely outcome. The outcome of these mixed effect regressions will permit a 
preliminary estimate of the mediational role of depression on A1c management in phase-I. We will estimate 
those indirect effects using bootstrapped standard errors using the MPlus modeling framework for longitudinal 
change from baseline to 6-months. Healthcare utilization outcomes both self-reported and obtained from LSCC 
will be harmonized into a composite score of utilization. Depending on the distribution of each aspect of 
utilization (ER visits, hospitalization, PCP visits), we will construct models to predict differences between the 
intervention and control arm while covarying change in A1c and depression from baseline to 12-months.  
 
For phase-II of the study, we have the opportunity to estimate two effects of interest including: a) the effect of 
the incentive and materials provision (2-selected items and health tool) on A1c among controls in phase-II over 
a period of 6-months compared to its effects when such provisions are coupled with empathy calls among 
intervention participants in phase-I (a between group effect estimate), b) the effects of exposure periods 
(phase-I and phase-II) on A1c and depression from baseline through 12-months separately for the two groups. 
In the case of the intervention group, the phase-I to phase-II difference gives clues to sustainability and in the 
case of the control group, the phase-I to phase-II difference provides a within-person estimate of the effect of 
incentive provision 
 
STUDY ELEMENT IDENTIFICATION 
6 
Study Elements 

Page 10 of 32 
 
 
Click on the check box (or double click and type an “X” if using Google Docs) each procedure included in your 
study. 
 
A full description of all study procedures should be provided in the Procedures (Details) section below and/or the 
applicable supplement form. 
 
 
 
☒ 
 
Bio-specimens 
☐ 
 
Biometrics 
☐ 
 
Registry or Repository 
 
☐ 
 
Focus Group 
☐ 
 
Genetic Analysis 
☐ 
 
Genomic Data Sharing 
 
☐ 
 
International 
Research 
☒ 
 
Interview/Survey 
☐ 
 
MRI 
 
☒ 
 
Protected Health 
Information 
☒ 
 
Observation 
☐ 
 
Radioactive Material/PET/Nuc. 
Med 
 
☒ 
 
Record Review 
☐ 
 
Sensors  
(Externally Placed) 
☐ 
 
Sensors  
(Inserted) 
 
☐ Video/Audio 
Recording 
☐ 
X-Ray/CT 
 
 
 
7 
Study Intervention 
 
Click on the check box (or double click and type an “X” if using Google Docs) if you will implement any of the 
following interventions. 
 
A full description of all study interventions should be provided in the Procedures (Details) section below and/or 
the applicable supplement form. 
 
 
 
☒ Behavioral 
☐ Device 
☐ Drug/Biologic 
 
 
8 
Clinical Trial  
 
Click on the following check box (or double click and type an “X” if using Google Docs) if the research meets the 
below definition of a clinical trial.  
 
 
 
☒ This study meets the definition of a clinical trial according to clinical trials.gov in 
that it involves one or more human subjects who are prospectively assigned to 
one or more interventions (which may include placebo or other control) to 
evaluate the effects of those interventions on health-related biomedical or 
behavioral outcomes. 
 
 

Page 11 of 32 
 
9 
Additional Oversight  
 
Click on the check box (or double click and type an “X” if using Google Docs) each activity that requires oversight 
from additional UT committees.  
 
 
 
☐ Energy introduced 
to the subject 
(electrical, 
magnetic, light) 
☐ Human embryonic, 
human induced 
pluripotent, or human 
totipotent stem cells; 
or human gametes or 
embryos 
☐ Radiation exposure without 
direct clinical benefit 
 
☒ Biological Samples, Biohazards, Recombinant DNA, or Gene Transfer  
 
 
If biological samples are used and stored on UT campus IBC approval is needed. 
 
a 
☐ 
Biological samples collected will not be stored on UT sites and another 
agency has responsibility for biospecimen safety. 
 
b 
IBC Protocol Number 
To input text, click in the light grey area below. 
IBC-2021-00220 
 
 
10 Alternatives to Participation in This Study 
To input text, click in the light grey area below. 
 
 
The alternative to participation is usual care at Lone Star Circle of Care (LSCC), the 
FQHC where we will be recruiting participants. 
 
 
 
 
STUDY PROCEDURE DESCRIPTION  
11 Procedure Description 
 
Describe all study procedures, including a step-by-step outline of what participants will be asked to do or how 
data will be used. Be sure to describe all of the following in detail, as applicable: 
 
- Provide a description of all research procedures being performed and when they are performed, in sequential 
order. 
- All research measures/tests that will be used and state if questions or measures are standardized or published 
(upload copies of all surveys, scripts and data collection forms) 
- Secondary data or specimens that will be obtained, how they will be collected, and how they will be used 
- Where each activity will take place, the duration of each, and who will perform each activity 
- Include time commitment of participants 

Page 12 of 32 
 
 
To input text, click in the light grey area below. 
 
 
1. Recruitment 
a. Interest List 
i. A database will be created by Lone Star Circle of Care (LSCC) to 
include patients who meet inclusion and do not meet exclusion 
criteria.  Messages will be sent out on the LSCC Care Message 
texting platform or emailed to identify interested participants from 
this database. 
ii. Lone Star Circle of Care (LSCC) staff will use flyers created by the 
research team to identify interested patients and a link to the 
recruitment flyer will be included in the CARE message text sent to 
LSCC patients when assessing interest in participating in the 
program. 
b. Consent 
i. Interested participants will be called by study staff to screen and 
share consent information.  Consent will then be signed 
electronically, through DocuSign, or for those that do not complete 
this, the first time they come to a clinic site, Dell Medical School at 
The University of Texas at Austin, community-based site, or on rare 
occasion in people’s homes, for baseline measurement, they will 
sign in person.  No research activities will take place before 
informed consent is completed. 
2. Measure collection 
a. General: Research associates/study staff will collect biomedical measures. 
Participants will fill out their own surveys on iPads/tablets at the measure 
collection site. Paper copies will be available for participants to complete 
upon request. Research associates will be blinded to the status of the 
participants. 
b. First measure collection 
i. After phone screening and consent, the participant will be invited 
to come the clinic site, Dell Medical School at The University of 
Texas at Austin, other community-based site, or on rare occasion in 
people’s homes on weekends and/or in the evenings and given 
choices on when to schedule measurement collection. When they 
come to the site, they will get a chance to sign consent forms if they 
haven’t done so electronically; then study staff will collect A1C and 
blood pressure measurements.  After this, participants will use a 
tablet or paper copy to answer survey information. The survey 

Page 13 of 32 
 
information will be saved directly into a RedCap database. The 
paper copy of the responses, if used, will be stored in a locked 
cabinet.  
c. Subsequent measure collections (3, 6, 9 and 12 months) 
i. Similar to above, without informed consent process. 
ii. The program improvement survey, administered at the 12-month 
(last) measurement visit will only be collected once, during the 12-
month visit. It will be collected from intervention participants only 
via the electronic tablet where all other measures are answered.  
3. Randomization 
a. To ensure that the effect of the empathy calls program can be assessed 
without confounding it with depressive mood, we will rely on stratified 
randomization so that approximately 50% (N=75) of the individuals in 
both the control and experimental group have a PHQ9 > 5 at baseline and 
50% of the individuals have PHQ9 < 5 at baseline. Randomization will 
occur after participant consent and collection of baseline measures.   
4. Program Intervention 
a. Intervention arm 
i. After the participant has been randomized into the intervention 
arm, they will be allocated to a caller’s panel by an unblinded 
program manager.  Each caller has a panel of anywhere from 10-25 
participants.  Callers will place the first call within 1-5 days of 
receiving the name of a participant. Callers will use an app on their 
phone to be reminded of the schedule of calls and to initiate calls 
such that basic metrics can be collected (e.g., the call occurred, call 
duration, etc). Calls are not recorded. 
ii. First week of the program: Choice of a health-promoting tool 
offered by the caller in the first week of the program.  A choice will 
be provided by the caller between a pedometer and a smart weigh 
scale of equivalent value. If neither of these options are applicable 
based on health or other limitations, back-up options will be 
offered to them (fitness resistant bands or exercise program for 
upper body fitness). The chosen health-promoting tool will be 
mailed out by the 5th week of the program. Low-literacy diabetes 
self-management information will also be mailed out after 
randomization occurs. 
iii. Month 2-5 of the program: Callers will select 2 items, one by Month 
2.5 (7 weeks in), and one by Month 4.5 (18 weeks in), and the 
program will mail these items to participants as personal 
recognitions of the participants managing diabetes in their life. The 

Page 14 of 32 
 
items will each be of <$25.00 value, will come from a pre-selected 
list of items that are related to the main levers of diabetes self-
management, nutrition, activity, sleep and med adherence. Callers 
will be allowed to add to the pre-selected list if they identify 
something they think will be particularly well-received by the 
participant but isn’t on the original list.  That item will then become 
part of the super set of items that other callers can choose from. 
Examples of items include cookbooks, blender, children’s cooking 
kit, spices, meal kits, gear to hold iPod and headphones while 
exercising, etc. 
iv. Empathy Calling Program (Months 1-6): Relationship-building 
empathetic telephone calls between lay caller and participant. Calls 
provide an opportunity for participants to discuss whatever they 
wish to share, and provide support for participant’s own goals on 
exercise, nutrition, sleep and medication adherence. In addition, if 
the caller feels the participant could benefit from a pre-selected list 
of YouTube videos, that includes people talking about their life with 
diabetes, the caller may decide to share it with them. Calls occur 3X 
a week in first month and 1X a week in subsequent months for 6 
months. Participants have agency in informing some aspects of how 
frequently they’re called.  After the first week they can adjust calls 
to a maximum of 5X a week or down to 2X a week (minimum of 
2X/week for the first month). After the fourth week all calls shift to 
weekly.  After the 8th week they can adjust calls to 2X every 4 weeks 
or stay on weekly schedule.  Calls average 10 minutes per call or 
less.   
v. Customized letters to panel participants by each caller.  The 
program will help transcribe and otherwise support via a template 
each caller describing learnings of their participants as they 
navigate life with diabetes, including trying to exercise or eat 
better. Anonymized learnings from participants in each caller’s 
panel will be compiled in the letter, which will be physically mailed 
out 2 times between Months 2 and 5. Both letters will be uploaded 
to the IRB for approval prior to administration. The first letter will 
be uploaded to the IRB via modification first, and the second letter 
will be uploaded approximately a month after the first one to 
match with the mailing schedule.  
vi. Follow-up Phase (Months 7-12): Automated Monthly text messages 
during months 7-12 (the follow-up phase) with pre-filled 

Page 15 of 32 
 
communications prepared by their caller as simple reminders of tips 
they discussed during the first 6 months. 
vii. Time commitment for research measures = no more than 45 
minutes for baseline and 30 minutes for every subsequent measure 
timepoint (3, 6, 9 and 12 months) Together with drive time to clinic, 
Dell Medical School, or community center sites for measurements 
we estimate 1.5 hours for each measurement, occasionally at a 
maximum 2 hours, and our compensation is based on 2 hours per 
visit and 5 measurement visits.   
viii. Time commitment for calls (estimated maximum) is:   
• Week 1: 30 minutes or less   
• Weeks 2-4: 50 minutes or less per week  
• Months 2-6: 10 minutes or less per week  
 
b. Control arm 
i. 
Program Phase (Months 1-6): Control participants will receive their 
usual care during the first 6 months of the program.  
ii. 
Follow-up Phase (Months 7-12): Through a survey at the end of the 
6-month assessment, control participants are provided the same 
health tools and ‘gift’ options as the intervention arm was at the 
beginning of the program phase.  They are provided a choice 
between a pedometer and a smart weigh scale (if neither of these 
options are applicable based on health or other limitations, back-up 
options will be offered to them (fitness resistant bands or exercise 
program for upper body fitness)); and they are provided a choice 
between the same set of items, each <$25.00 and all related in 
some way to eating better, exercise, sleep or tools to help 
remember to take medications.  The health tool and diabetes self-
management information is delivered via mail on the same 
schedule as the intervention participants. The gifts selected by 
control participants will be mailed in Month 2 and Month 4. 
iii. 
Time commitment for control measurements – same as for 
intervention, see above.  
iv. 
Time commitment for control intervention – none. 
 

Page 16 of 32 
 
SUBJECT POPULATION 
 
 
12 
Protected Subject Populations 
Click on the check box (or double click and type an “X” if using Google Docs) each population, if they are 
specifically studied for this research. 
 
 
☐ 
 
Active military 
personnel 
☐ 
 
Children 
☐ 
 
Decisionally impaired adults 
 
☐ 
 
Emancipated 
minors 
☐ 
 
Fetuses 
☐ 
 
Individuals with limited 
English proficiency 
 
☐ 
 
Neonates 
☐ 
 
Pregnant Woman 
☐ 
 
Prisoners 
 
☐ 
 
UT Students 
☐ 
 
UT or Seton 
Staff/Employees 
 
13* Research Participant Information 
Describe the research population. 
 
*For multiple research populations (e.g., teachers, students, and parents), copy this section as necessary to 
describe your population. 
 
Participants are patients with diabetes who are seen at Lone Star Circle of Care, a Federally Qualified 
Health Center (FQHC) in the greater Austin region.   
 
a Participant Group Name 
To input text, click in the light grey area below. 
Diabetic adults seen at Lone Star Circle of Care, a Federally Qualified Health Center  
b Minimum Age 
To input text, click in the light grey area below. 
21 
 
c Maximum Age 
To input text, click in the light grey area below. 
70 
 
d Inclusion Criteria 
To input text, click in the light grey area below. 
 
 
Adults aged 21 to 70 years old 
A1c >= ≥7.5 at baseline measurement and 8.0 at least one time in prior 12 months. 

Page 17 of 32 
 
 
 
SCREENING AND RECRUITMENT 
At least one visit with Lone Star Circle of Care within the past 12 months (in person or telehealth) 
Must be willing to answer the PHQ-9 form in its entirety at baseline data collection due to stratified 
randomization design. 
 
 
e Exclusion Criteria 
To input text, click in the light grey area below. 
A1c < 7.5 at baseline measurement. Refusal to answer the PHQ-9 form in its entirety at baseline data 
collection due to stratified randomization design. Moderate to severe cognitive impairment currently 
pregnant, undergoing cancer treatment, diagnosis of end-stage renal disease or serious mental illness 
diagnosis, moderate to severe cognitive impairment, or receiving systemic treatment with prednisone 
or immunosuppressant therapy following an organ transplant.  
 
f Additional Population Information 
To input text, click in the light grey area below. 
 
14 Total Sample Size 
To input text, click in the light grey area below. 
300 
15 
Sample size rationale 
To input text, click in the light grey area below. 
To ensure that the effect of the empathy calls program on A1c can be assessed without confounding it with 
depressive mood in the first 6-month phase-I portion, we will rely on stratified randomization so that 
approximately 50% (N=75) of the individuals in both the control and experimental group have a PHQ9 ≥5 at 
baseline and 50% of the individuals have PHQ9 <5 at baseline. With 150 individuals in each arm, three 
assessments for A1c, the primary outcome, and depression (PHQ9), secondary outcome, we have 80% 
statistical power with alpha = .05 to detect effects as small as f = .09, which is a small, standardized effect size, 
and have 90% power to detect effects as small as f = .10, also a small effect size, assuming only a moderate 
correlation for rank-order stability across time for each outcome of r = .30. This correlation is reasonable for 
A1c and is an underestimate for the typical correlation for PHQ9. Statistical power for the effect of interest 
increases as these correlations in the outcome measures goes up. Regarding correlations, we have 90% power 
to detect correlations as small as r = .26 and 80% power to detect correlations as small as r = .23 within each 
group (N = 150) at alpha = .05. These are fair to moderate effect sizes that bear on the power of any follow-up 
mediation analyses.  
 
16 
Identification and Screening 
 
Click on the check box (or double click and type an “X” if using Google Docs) if true. 
 

Page 18 of 32 
 
 
17 
Identification and/or Screening Procedures 
Describe the identification and/or screening procedures below. 
To input text, click in the light grey area below. 
i. 
A database will be created by Lone Star Circle of Care (LSCC) to include 
patients who meet inclusion and do not meet exclusion criteria.   
ii. 
Messages will be sent out on the LSCC Care Message text platform or via 
email to identify interested participants from this registry. 
iii. 
Lone Star Circle of Care (LSCC) staff will use flyers created by the team (and 
submitted with this IRB submission) to identify interested patients. A 
webpage link to the recruitment flyer will be included in the CARE message 
text sent to LSCC patients by LSCC staff.  
iv. 
Research team members will call interested patients to explain the research 
and provide informed consent over the phone using DocuSign or in person at 
baseline visit. 
 
 
 
19 
Describe the recruitment process, including where recruitment will take 
place. 
Describe the recruitment procedures below. 
 
☒ This study involves obtaining information or biospecimens for the purpose of 
screening, recruiting or determining eligibility of prospective subjects prior to 
informed consent by either: 
1. 
Oral or written communication with the prospective subject or LAR 
2. 
By accessing records containing identifiable private information or stored 
identifiable biospecimens. 
18 
Recruitment Overview 
 
Click on the check box (or double click and type an “X” if using Google Docs) all recruitment methods utilized for 
this research. 
 
 
☒ E-mail 
☒ Flyer 
 
☒ In-Person 
☒ Letter 
 
☐ Social Media 
☐ Research Pool 
 
☒ Telephone/Text 
☐ Snowball Sampling 
 
☐ Web-post 
☐ Word of Mouth 

Page 19 of 32 
 
To input text, click in the light grey area below. 
a. Interest List 
i. 
A participant qualifying list will be created by Lone Star Circle of Care 
(LSCC) to include patients who meet inclusion and do not meet 
exclusion criteria.  Individuals with authorization will collect the initial 
PHI to create a list of patients that would like to be contacted by the 
research team. They will provide this list of names, e-mails, and 
phone numbers to the research team so we can call and provide 
detailed information about the research and determine if patients 
would like to participate. Messages will be sent out on the LSCC Care 
Message text platform or email to identify interested participants 
from this database. 
ii. 
Lone Star Circle of Care (LSCC) staff will use flyers created by the team 
(and submitted with this IRB submission) to identify interested 
patients. 
iii. 
LSCC staff creating the interest list will be considered research team 
members and will be added to the IRB once they have been selected 
and trained (CITI). 
b. Consent 
i. 
Interested patients will be called by study staff to screen and share 
consent information.  Consent will then be signed electronically, 
through DocuSign, or for those that do not complete this, the first 
time they come to their regular LSCC clinic site, Dell Medical School at 
The University of Texas at Austin, or community-based site, for 
baseline measurement, they will sign in person. 
c. Measure collection – A1C measure 
i. 
Research associates/study staff will collect HbA1C at in person visit 
after consent is signed.  Individuals with HbA1C less than 7.5 will be 
considered a screen fail.  
d. Measure collection – PHQ-9 
i. 
After consent is signed and HbA1C is measured during the first in-
person visit, research associates/study staff will give a tablet or paper 
copy to the participant for them to complete the questionnaires. One 
of the first few questionnaires is the PHQ-9, which will have all 
questions marked as required, so that the participant cannot move 
ahead in the surveys unless each question is answered. This approach 
is needed to ensure adequate and fair stratified randomization. 
Participants that flag to the research associates/study staff that they 
do not want to complete the PHQ-9 questionnaire will be informed 
that they will not be able to join the study. 

Page 20 of 32 
 
 
 
 
 
OBTAINING INFORMED CONSENT 
 
 
20 
Consent Overview 
 
Click on the check box (or double click and type an “X” if using Google Docs) all applicable items. 
 
 
☒ Obtaining Written Informed 
Consent 
☐ Requesting a Waiver of Documentation of 
Informed Consent 
 
☐ Requesting a Waiver of 
Informed Consent 
☐ Requesting an Alteration of the Required 
Elements of Informed Consent 
 
☐ Obtaining Child Assent 
☐ Obtain Consent Using a Short Form with a 
Witness 
21 
Consent and Assent Processes 
 
Provide a detailed description of the consent process including who will obtain consent, where, and when 
consent will occur in such a manner that participants have sufficient time for adequate consideration. 
 
To input text, click in the light grey area below. 
i. 
Interested patients will be called by study staff to screen and share consent 
information.  Consent will then be signed electronically, through DocuSign, or for 
those that do not complete this, the first time they come to a clinic site, Dell 
Medical School, other community-based site, or on rare occasion at people’s homes, 
for baseline measurement, they will sign in person.  Study staff/research associates 
will share detailed information about the consent and be present in person to get 
signatures and subsequently, baseline measures at the first timepoint. 
 
 
 
22 
Consent and Translation 
 
Click on the check box (or double click and type an “X” if using Google Docs) to indicate that consent will be 
translated. 
 

Page 21 of 32 
 
 
 
☒ 
The study population will likely include participants whose limited English 
speaking status requires translation of the consent form. 
 
 
Translation Process 
Click on the check box (or double click and type an “X” if using Google Docs) that best describes the translation 
process, either 21 or 22. 
 
23 
☐ 
The consent documents will be translated by a certified translator. 
 
24 
☒ 
A non-certified translator will translate the consent documents. 
 
i Describe the translator’s qualifications 
To input text, click in the light grey area below. 
Two English fluent and native Spanish speakers within research personnel. One 
will translate and the other will confirm translation. 
 
ii ☒ 
Another individual will confirm that the translation is accurate and 
appropriate. 
 
Waiver of Documentation of Informed Consent  
 
To approve a waiver of documentation of informed consent, one of the following options below must be 
justified by the researcher. 
 
Only complete the sections below if requesting a waiver of documentation of informed consent. If not 
requesting a waiver of documentation of consent, skip to 27. 
 
Please choose one waiver option and provide additional information as prompted. The Office of Research 
Support and Compliance recommends using Waiver Option 2 in most cases. 
 
25 
Waiver Option 1 
 
Provide confirmation for the following criteria and follow the additional instructions. 
 
Additional Instructions: 
1. Include this choice in the informed consent form.  
2. Articulate the destruction process for signed consent forms in the privacy and confidentiality section. 
 
Click on the check box (or double click and type an “X” if using Google Docs). 
  
a ☐ 
 
The only record linking the subject and the research would be the consent 
document. 
b ☐ 
 
The principal risk would be potential harm resulting from a breach of 
confidentiality. 

Page 22 of 32 
 
 
c ☐ 
 
Each subject will be asked whether the subject wants documentation linking the 
subject with the research, and the subject’s wishes will govern. 
26 
Waiver Option 2 
Provide confirmation for the following criteria and follow the additional instructions. 
 
Click on the check box (or double click and type an “X” if using Google Docs).  
 
a ☐ 
 
The study is minimal risk. 
b ☐ 
 
Written consent would not be required outside the research context. 
27 
Waiver Option 3 
Provide confirmation for the following criteria and provide additional information as requested. 
 
Click on the check box (or double click and type an “X” if using Google Docs).  
 
a ☐ 
 
The subjects or legally authorized representatives are members of a distinct 
cultural group or community in which signing forms is not the norm 
b Describe the cultural group or community. 
To input text, click in the light grey area below 
 
 
c ☐ 
 
The research presents no more than minimal risk of harm to subjects. 
d ☐ 
 
There is an appropriate alternative mechanism for documenting that informed 
consent was obtained. 
e Describe mechanism for documenting that informed consent was obtained 
To input text, click in the light grey area below 
 
 
 
Waiver or Alteration of Informed Consent  
 
To approve a waiver or alteration of informed consent all of the following criteria below must be justified by the 
researcher. 
 

Page 23 of 32 
 
 
 
Only complete the sections below if requesting a waiver of informed consent.  If not requesting a waiver or 
alteration of consent, skip to 31. 
 
28 
The research involves no more than minimal risk to the subjects. 
To input text, click in the light grey area below 
 
 
 
29 
The waiver or alteration will not adversely affect the rights and welfare of the 
subjects. 
To input text, click in the light grey area below 
 
 
 
30 
The research could not practicably be carried out without the waiver or alteration (it 
is impracticable to perform the research if obtaining informed consent is required and 
not just impracticable to obtain consent). 
To input text, click in the light grey area below 
 
 
 
31 
If the research involves using identifiable private information or identifiable 
biospecimens, the research could not practicably be carried out without using such 
information or biospecimens in an identifiable format. 
To input text, click in the light grey area below. 
 
 

Page 24 of 32 
 
 
BENEFITS 
36 
Benefits to Society 
Describe the scientific and societal benefit(s) below. 
 
To input text, click in the light grey area below. 
We hypothesize that providing empathetic and relationship-oriented telephone calls by 
lightly trained lay persons can support diabetes self-management behaviors and reduce 
Hemoglobin A1c.   By measuring the impact of such a lay person driven program on 
Hemoglobin A1C and mental health we plan to build a case for the health system to 
pay for better outcomes through such programs and influence the development of a 
novel workforce. 
 
 
Deception and Debriefing 
Only complete the sections below if requesting an alteration of informed consent that involves deceiving 
research participants. If this study does not involve deception, skip to 35. 
 
See IRB Policies and Procedures Section 15 for a description of deception. 
 
 Click on the check box (or double click and type an “X” if using Google Docs).  
32 
☐ It is appropriate to provide additional pertinent information to the subject after 
research activities are complete (e.g., the researcher needed to deceive to subject 
to the nature of the study). 
33 
☐ Research participants will have the opportunity to withdrawal their data during 
the debriefing. 
34 
Describe the nature of deception and why it is necessary to conduct the research. 
To input text, click in the light grey area below. 
 
 
35 
Describe debriefing procedures. 
To input text, click in the light grey area below. 
 
 

Page 25 of 32 
 
 
Benefits to Participants 
Click on the applicable check box (or double click and type an “X” if using Google Docs). 
 
37 
☐ 
There is no anticipated direct benefit to participants. 
 
38 
☒ 
There are anticipated benefits to participants. 
 
39 
If applicable, describe the potential direct benefits to participants. 
To input text, click in the light grey area below. 
• Participants in the intervention arm will receive phone calls that may make them 
feel better by having someone listen and empathize with them.    
 
 
RISKS 
40 
Describe the risks associated with each activity in this research 
To input text, click in the light grey area below. 
• Finger stick blood sample for HbA1c blood testing: The risks of obtaining a blood 
sample are minimal, similar to any time blood is collected and include pain, 
bleeding, bruising, infection, and skin irritations (from cleaning agents used to 
sterilize the skin or bandages).  
• Blood Pressure: Participants may experience mild discomfort in their arm when 
the cuff is inflated. 
• Loss of confidentiality: There is a potential for accidental release of confidential 
information.  Procedures are in place to minimize this risk. 
 
 
 
 
41 
Describe how each risk is mitigated/minimized. 
To input text, click in the light grey area below. 
• Study team members collecting BP and blood samples will be trained on proper 
technique to maintain safety and minimize discomfort 
• Participant study numbers and a secure REDCap database will be used to protect 
patient confidentiality.  
 
 
 

Page 26 of 32 
 
 
Data Safety Monitoring 
For additional information regarding data safety monitoring boards and data safety monitoring plans, please 
see Section 21 of our Policies and Procedures. 
 
Click on the check box (or double click and type an “X” if using Google Docs). 
 
42 
☒ 
This study is minimal risk and does not require a Data Safety Monitoring Plan 
(DSMP) or a Data Safety Monitoring Board (DMSB). 
 
43 
☐ 
This study does not have a Data Safety Monitoring Board, but researchers have 
an internal plan/policy to monitor for safety. 
Complete Data Safety Monitoring Details (44-51). 
 
44 
☐ 
This study has a Data Safety Monitoring Board (DSMB). 
Complete Data Safety Monitoring Details (44-51) or upload this study’s Data Safety Monitoring Board’s 
charter. 
 
 
Data Safety Monitoring (Details) 
 
45 
How is safety information collected? 
To input text, click in the light grey area below. 
 
 
 
46 
When will safety data collection start (for each participant or for the whole study, as 
applicable)? 
To input text, click in the light grey area below. 
 
 
 
47 
How frequently will safety data be collected? 
To input text, click in the light grey area below. 
 
 
 
48 
Who will review the data for safety? 
To input text, click in the light grey area below. 
 
 
 
49 
How frequently will data be monitored for safety concerns? 
To input text, click in the light grey area below. 
 
 

Page 27 of 32 
 
 
50 
What data will be reviewed? 
To input text, click in the light grey area below. 
 
 
 
51 
State the frequency or periodicity of the review of cumulative data? 
To input text, click in the light grey area below. 
 
 
 
52 
State any conditions that would trigger an immediate suspension of the research. 
To input text, click in the light grey area below. 
 
 
 
 
 
Early Withdrawal 
Only complete this section if there are planned conditions under which a participant will be withdrawn from 
the study. If not applicable, skip to 56. 
 
Include this information in your consent form. 
 
 
 
53 
List the criteria for withdrawing individual participants from the study (e.g., safety 
or toxicity concerns, emotional distress, inability to comply with the protocol, or 
requirements from study sponsor). 
To input text, click in the light grey area below. 
  Participants may be withdrawn from the study if they verbally abusive or 
inappropriate with callers. 
 
 
54 
Describe any necessary procedures for ensuring the safety of a participant who has 
withdrawn early. 
To input text, click in the light grey area below. 
There are no procedures in place to ensure the safety of a participant that is 
withdrawn for abusive or inappropriate behavior toward callers.  This is a minimal risk 
study and being withdrawn poses no risk to the participant. 
 
55 
Describe any pre-specified criteria for stopping or changing the study protocol due 
to safety concerns. 
To input text, click in the light grey area below. 

Page 28 of 32 
 
None 
 
 
REQUIRED DISCLOSURES 
 
 
Required Consent Disclosures  
Identify each element below that may require additional information to be disclosed in the consent form. 
 
Click on the check box (or double click and type an “X” if using Google Docs).  
 
56 
☒ 
It is reasonable that researchers could discover or suspect child or elder abuse. 
57 
☐ 
It is reasonable that researchers could learn of an incident that could require 
reporting under Title IX. 
58 
☒ 
It is reasonable that researchers could discover incidental findings or other 
information of medical interest about a participant's previously unknown 
condition. 
59 
Articulate methods for addressing and reporting incidental findings, if 
applicable. 
To input text, click in the light grey area below. 
If during the study, we learn about child or elder abuse or neglect, or that someone is a clear, 
serious, and direct harm to self or others, we may report the information to the appropriate 
authorities, including the police, the Texas Department of Family and Protective Services, 
Lone Star Circle of Care and/or an emergency medical facility. 
 
In the event a participant includes a response of 1-3 on the PHQ-9 question #9, the following 
protocol will be activated: 
1. REDCap real-time notification via email to assigned research staff person while 
participant completes remaining surveys 
2. Research team alerts Dr. M. Renee Valdez, Director of Psychiatry and BH at 
LSCC, immediately and normal LSCC procedures will occur to escalate issue to 
offer resources (direct phone call by BH provider) 
 
 

Page 29 of 32 
 
PRIVACY AND CONFIDENTIALITY 
 
 
60 
Privacy 
Describe how you will protect the identity and privacy of study participants during each phase of research. 
Privacy focuses on the individual participants rather than data. In this section, researchers should focus on 
issues such as where research activities take place and how participant involvement is protected from non-
participants. 
 
Describe methods to ensure participants’ privacy during identification, recruitment, screening, the consent 
process, the conduct of the study, and dissemination of data. 
 
To input text, click in the light grey area below. 
Participant privacy will be maintained by conducting research visits in a private room or 
if in a large space, by providing adequate distance to ensure privacy.  Surveys will be 
completed by participants using tablets further ensuring privacy. If participant chooses 
to complete surveys with a hard copy, it will be stored in a locked cabinet before and 
after measurement collection. All intervention procedures (phone calls) will be 
conducted using a phone number provided by the participant. 
 
Confidentiality and Data Security Plan 
Click on the check box (or double click and type an “X” if using Google Docs) that best describes the 
confidentiality and data security plan and provide additional details regarding how you will protect the 
confidentiality of data or address confidentiality concerns.  
 
61 
☐ Identifiers will be coded to protect confidentiality. 
 
61a If true, state how data is coded and where identifiers are stored. 
To input text, click in the light grey area below. 
 
 
62 
☒ Identifiable data will be destroyed. 
 
62a If true, describe destruction plan and timeline 
To input text, click in the light grey area below. 
Identifiers will be destroyed at the end of the study after all data has been analyzed.  All data will 
be stored in the Dell Med REDCap database.  This secure, HIPAA compliant database can only be 
accessed with password and dual authentication. Hard copies of the measurements will be 
available to participants upon request. If participant chooses to complete measurements with a 
paper copy, responses will be entered in the REDCap database, and the paper copy will be stored 
in a locked cabinet until it is destroyed with the other data (after it has been analyzed).  
 

Page 30 of 32 
 
 
 
64 Data Access 
 
Click on the check box (or double click and type an “X” if using Google Docs) for each group of individuals that 
will have access to study data. 
 
If you plan on creating a repository, complete the repository form as well. 
 
 
☒ Study Team 
Members 
☒ External Collaborators 
☐ Data coordinating center 
 
☐ Sponsor 
☒ Future Sharing with 
other researchers 
 
☐ Others 
Describe below. To input text, click in the light grey area below. 
 
63 
☐ Identifiable data will not be destroyed. 
 
63a If true, provide rationale for retaining identifiable data indefinitely. 
To input text, click in the light grey area below. 
 
65 
Describe data sharing plan for each group checked above and state whether 
researchers plan on sharing identifiable, coded, or de-identified data 
To input text, click in the light grey area below. 
No identifiable research data will be shared outside of the research team. Aggregate 
data will be shared with LSCC and presented in public. 
 
We may share data with other researchers for future research studies that may be 
similar to this study or may be very different. The data shared with other researchers 
will not include information that can directly identify the participant 
 
Certificate of Confidentiality  
Click on the check box (or double click and type an “X” if using Google Docs) to identify each element below that 
may require additional information to be disclosed in the consent form. 
 
If a Certificate of Confidentiality is not applicable for this study, skip to 68. 
 
66 
☐ The study requires a Certificate of Confidentiality. 
67 
☐ NIH has issued a Certificate of Confidentiality for this study. 

Page 31 of 32 
 
COMPENSATION AND COSTS 
 
☐ 
Cash 
☐ Check 
☒ Gift Card 
 
☐ 
Course Credit 
☐ ClinCard 
☒ Tango Card 
 
☐ 
Other 
Describe, To input text, click in the light grey area below. 
 
 
 
68 
☐ A Certificate of Confidentiality has not been obtained, but there are plans to 
apply for one. 
Compensation  
Click on the check box (or double click and type an “X” if using Google Docs). 
 
69 
☒ Subjects receive compensation. 
70 
☐ Subject will not receive compensation. 
Skip to question 74 if subjects will not receive compensation. 
71 
Total Amount of Compensation 
To input text, click in the light grey area below. 
Participants will be paid $50.00 for each measurement visit for a maximum of $250.00 
for 5 visits. 
 
72 
Type of Compensation 
Click on the check box (or double click and type an “X” if using Google Docs) for each form of compensation that 
will be provided. 
 
73 
Proration Schedule 
To input text, click in the light grey area below. 
Participants will be paid $50.00 for each measurement visit for a maximum of $250.00 
for 5 visits. 
 
74 
☒ Amount of compensation and its form is reasonable for this population for the 
activities requested of them. 
75 
Costs 

Page 32 of 32 
 
 
 
Click on the check box (or double click and type an “X” if using Google Docs) each applicable item regarding 
costs. 
 
 
☐ 
Participants will have no costs associated with this study 
 
☐ 
Standard of care procedures 
contributing to study data 
 
☐ Research procedures not associated with 
standard of care 
 
☐ 
Administration of drugs / 
devices  
☐ Study drugs or devices 
 
☒ 
Transportation and parking  
76 
Describe all costs below. 
To input text, click in the light grey area below. 
 
There is a small cost to travel to the study visit sites.  This will vary from one participant 
to the next, but will be negligible for most.