Patient and Provider Engagement and Empowerment Through Technology (P2E2T2) Program to Improve Health in Diabetes
Phase: NA
Conditions: Diabetes Mellitus
Sponsor: University of California, Davis

PROTOCOL TITLE:  
Patient and Provider Engagement and Empowerment through Technology  
(P2E2T2) to Improve Health in Diabetes 
 
 
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Version: April 11, 2019 
 
January 7, 2015 
 
NCT number: NCT02672176 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE:  
Patient and Provider Engagement and Empowerment through Technology  
(P2E2T2) to Improve Health in Diabetes 
 
 
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Version: April 11, 2019 
 
 
1) 
Protocol Title: 
Patient and Provider Engagement and Empowerment through Technology (P2E2T2) to 
Improve Health in Diabetes 
2) 
Author of Protocol:   Yajarayma (Yaya) Tang Feldman, Sheridan Miyamoto, Madan 
Dharmar and Sarina Fazio 
Principal Investigator:  Heather M Young 
 
 
X 
UC Davis Researcher 
 
Researcher from other institution 
 
Private Sponsor 
 
Cooperative Group 
 
Other: _________________ 
 
3) 
IRB Review History- New 
 
 
 
4) 
Objectives 
 
The overall goal of this proposal is to enhance the supports and resources available to 
patients with diabetes to assist them to achieve their health goals.  We will evaluate an 
innovative program  that uses nurse health coaching, motivational interviewing 
techniques, wireless sensors and mobile health (mHealth) technology based on input from 
patients, providers and technology experts as to how best to address the healthcare needs 
of persons living with diabetes and improve their health and wellness.    
 
The P2E2T2 program is funded by a grant from the Patient-Centered Outcomes 
Research Institute (PCORI). The focus of this proposal is to attend to the patient 
regarding what is needed from the health care team and from technology to optimally 
support patients to succeed in reaching self-identified goals to better manage their 
diabetes.  In this program, patients will receive timely, tailored nurse coaching 
feedback to facilitate behavior change using mHealth technology, thus bridging 
bidirectional exchange of meaningful information among patient, nurse coach and 
provider.  We will conduct a randomized controlled trial among patients receiving 
chronic disease management at the University of California, Davis Primary Care 
Network.  The patients who are eligible for inclusion in the study will be randomized 
to one of two arms of the trial:  1) Care Coordination (usual care) administered by UC 
Davis Health Management and Education (new name); or 2) the Patient and Provider 
Engagement and Empowerment through Technology (P2 E2 T2) Program to Improve 
Health in Diabetes.   
Our hypothesis is that patients in the P2E2T2 arm of the study will be more engaged in 
identifying and achieving health goals related to their diabetes and will achieve better 
health outcomes compared to patients receiving usual care.    

PROTOCOL TITLE:  
Patient and Provider Engagement and Empowerment through Technology  
(P2E2T2) to Improve Health in Diabetes 
 
 
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We will achieve this project through the following Specific Aims: 
 
Specific Aim 1:  To evaluate the effectiveness of the P2E2T2 program on diabetes 
management as measured by the following outcomes:  1) quality of life 
(QOL); 2) self-efficacy; 3) readiness to change; and 4) clinically relevant 
outcomes. 
Specific Aim 2: Compare specific health and fitness outcomes of individuals 
participating in each study arm. 
 
5) 
Background 
 
Diabetes 
Diabetes mellitus (DM) is a growing public health problem highly amenable to 
prevention and health promotion interventions.  Over 26 million people are diagnosed 
with diabetes, and an estimated 79 million people have pre-diabetes (1).  The incidence of 
DM in the United States is escalating at alarming rates and by 2050, 48.3 million people 
will be diagnosed with diabetes, an increase of 198% from 2005 (2, 3).  Type-2 diabetes 
is the most common type of diabetes accounting for 80-95% of cases (2-4).  DM is a 
major risk factor for vascular complications including heart disease and stroke, 
hypertension, blindness, lower limb amputations, lipid abnormalities and kidney disease 
(5-8).  
 
Health Behavior and Disease 
Physical inactivity, poor eating habits, obesity and smoking are common risk factors 
for multiple chronic diseases, including DM, and are associated with premature deaths 
in the United States (40% of premature deaths compared to other factors such as 
genetic predisposition (30%), social circumstances (15%), health care (10%), and 
environmental exposures (5%)) (9).  Recent evidence suggests an association between 
sleep impairment and type-2 diabetes, where duration and quality of sleep were 
significant predictors of glycemic control, suggesting that interventions which address 
sleep quality may be of value in glycemic control and diabetes management (10-13).   
These connections between health behavior and disease outcomes indicate the 
importance of a patient-centered, proactive and evidence based approach to 
prioritizing and enacting behavioral choices (14).   
 
Gaps in Traditional Management of Diabetes 
Traditional interventions for diabetes include face-to-face counseling in clinics, 
individual visits with a diabetes educator, or group classes (15). These interventions 
emphasize education and typically do not address patient-generated goals and personal 
motivations.  Another gap in usual treatment is the lack of community-based patient 
generated data that can inform patient-provider conversations about progress and 
about the impact of certain behavioral choices upon health outcomes.  Such data could 

PROTOCOL TITLE:  
Patient and Provider Engagement and Empowerment through Technology  
(P2E2T2) to Improve Health in Diabetes 
 
 
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increase awareness and reinforce patient engagement in health choices and provide 
feedback to providers about effectiveness of treatment approaches.  
Some significant strides have been made in improving diabetes outcomes by delivering 
real-time diabetes management feedback to patients based on glucose readings that 
patients upload through mobile technology (16).  Our proposal focuses on using 
commercially available, non-proprietary sensors that can capture a variety of 
measurements/types of data combined with nurse health coaching using Motivational 
Interviewing (MI) to support patients in setting and attaining health behavior goals.  
Benefits of our strategy are that the skills the patient discovers with the support of the 
nurse coach have the potential to translate to other types of behavior change going 
forward.  The patient can learn what motivates them to improve their health, what 
empowers them to stay focus on health improvement, how to set reasonable goals and 
how to overcome barriers to change.  These skills can be readily applied to behavior 
change aimed at improving diabetes or any other chronic disease or wellness goal.  By 
creating a mHealth platform that is ubiquitous and works with non-proprietary sensing 
devices, patients can use the sensors to provide data essential to behavior change that 
may impact other disease processes.  Creating a model for interaction that is flexible in 
the type of data that can be collected will allow for providers, health systems and insurers 
to invest in testing new models of care and scaling those that prove effective within a 
sustainable system.  
Evidence for Motivational Interviewing as an approach 
Interventions that involve active patient participation are likely to have longer and 
more positive clinical and psychosocial outcomes than didactic interventions in which 
there is limited patient input (15, 17) .  MI is a counseling tool to improve self-efficacy 
and support behavioral changes that has been used successfully in treatment of 
addictions and chronic conditions including diabetes (18-23).  MI focuses on 
enhancing goal-setting skills by encouraging focus on manageable steps to improve 
overall health, establishing reasonable goals, and managing barriers and obstacles to 
goal attainment.  It helps build the patient’s capacity to problem-solve and has a wider 
applicability to extend to other health and wellness goals. Because prevention of 
chronic disease involves multiple lifestyle and behavior choices across many domains 
(nutrition, physical activity, medication adherence, stress management, etc.), 
incremental improvements in a patient’s capacity to set and attain reasonable goals 
could advance overall self-care. MI has been successfully used in treatment of weight 
loss and glycemic control (24-25).   
 
In our previous study testing MI using telehealth (via telephone connection) with 
individuals living with diabetes in rural, underserved communities, we showed that 
short-term improvements in diabetes self-efficacy reported by other studies can be 
extended to lasting long-term effects (23). Through our experience coaching 
participants with diabetes to achieve their health goals, we learned that participants are 
motivated when they focus on goals that are important to them.  As nurse coaches, we 
were able to help participants identify health goals (commonly selected by participants 
to focus on physical activity or healthy eating) they believed to be important and to 

PROTOCOL TITLE:  
Patient and Provider Engagement and Empowerment through Technology  
(P2E2T2) to Improve Health in Diabetes 
 
 
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identify their motivation to consistently work toward achieving their goals.  The gap 
we recognized in this previous study was that we were reliant on self-report of 
physical activity and other indicators and were unable to uncover trends in behavior 
that would allow participants to identify barriers to goal achievement or make 
adjustments. For example, we recognized that having timely community living data 
regarding physical activity would be useful to both patient and coach in evaluating 
progress to goals and addressing barriers, as well as providing an opportunity to reflect 
on  trends which may help the patient recognize an opportunity for change or reinforce 
a positive health behavior.  This technology, in essence, allows for a fuller 
understanding of a patient’s experience outside the clinic walls and allows the health 
care team to provide timely and personal feedback to adjust and sustain health 
behaviors.  If successful, the proof-of-concept and framework that is developed by the 
proposed project will not only benefit diabetic care, but will have far-reaching 
applications for other chronic disease management. 
Role of technology in improving patient engagement and outcomes 
When mobile health is connected with sensors that are either embedded in the 
environment or on the person, it “can produce continuous streams of data on an 
individual's biology, psychology (attitudes, cognitions and emotions), behavior, and 
daily environment (15).  If this technology is harnessed to allow bi-directional, timely 
communication of data and tailored feedback, it has the potential to change an 
individual’s health behavior and prevent or mitigate the factors that lead to disease.  
Given that 96% of the United States population is currently living in areas where 
mobile networks exist, the potential to reach underserved populations and reduce 
health care disparities is another great promise of mHealth technologies (16).  Mobile 
technology allows care to move from traditional clinic and hospital-based care to 
where individuals are in their daily lives.  With 91% of adults in the United States 
reporting they own a mobile phone (17) and 63% of adult cell phone owners reporting 
use of their phone to access the internet (18), it appears the barriers to mHealth 
technology access are being quickly overcome and will assume a larger role in future 
health care.  
 
 
6)  
Inclusion and Exclusion Criteria 
 
Participants will be recruited from UC Davis Primary Care Clinics, including the 
Hospital-based clinic and the Folsom Medical Group clinic.  After enrollment in the 
study, participants will be randomized into one of two groups:  Care Coordination (usual 
care) offered through UC Davis Health Management and Education; or the (P2 E2 T2) 
Program to Improve Health in Diabetes (intervention), which includes nurse coaching 
paired with sensor technology to provide targeted feedback of patient generated real-
world physical activity and sleep quality data to the nurse coach, participants and primary 
care providers to improve self-management of diabetes.  Those randomized to receive the 
intervention will interact with their coach through mobile technologies by telephone, 
face-to-face videoconference, or by text/e-mail through EPIC MyChart, the electronic 
health record system used by UC Davis Health System, that is secure and HIPAA 

PROTOCOL TITLE:  
Patient and Provider Engagement and Empowerment through Technology  
(P2E2T2) to Improve Health in Diabetes 
 
 
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protected. The secure mHealth dashboard platform (Synopsis) is developed within EPIC 
Hyperspace for communication and collection of data. The telephone and face-to-face 
videoconference interactions will be initiated by the nurse coach from a secure location. 
All other interactions with patient happen within the electronic health record environment 
which is secure. 
 
Inclusion criteria will be: 
1) At least 18 years of age 
2) Diagnosis of Diabetes Mellitus (type 2) 
3) Receiving care at one of the UC Davis Primary Care participating clinics 
(hospital-based Primary Care Clinic, the Folsom Primary Care Clinic) 
4) Able to read, write, and speak English  
5) Has access to a telephone and computing device  
6) Has had experience with use of a mobile smartphone & applications 
 
 7) HgbA1C over 6.5% 
 
 
Exclusion criteria will be:  
1) Does not have Diabetes Mellitus  
2) Primary language is not English  
3) Pregnant women  
4) Those that not have access to a telephone or computing device  
5) Has a HgbA1C value under 6.5% 
7) 
Number of Subjects 
 
Sample Size and Power analysis: Based on our previous study of nurse coaching using 
MI to improve disease self-management (23), we found improvement in self-efficacy 
scores significantly higher in the intervention group compared to the control group.  
Based on these data, we expect to find self-efficacy scores to be 4.03 and 3.64, for the 
intervention and control group respectively, with a standard deviation of 0.70.  Table 1 
presents the sample size calculations for the number of eligible patients needed to 
detect significant differences in self-efficacy scores between the cohorts.   
 
According to the anticipated enrollment calculations above, we expect to enroll at least 
150 patients in each of the intervention and control cohorts.  This sample size will be 
sufficient to detect differences between the two groups as demonstrated in Table 1.  In 
the previous study, we had a low overall attrition rate of 16% using a similar 
intervention design with comparable demand on participants for time and response. 
Even under the conservative assumption that design effects and dropout rates may 
result in a reduced sample size of 100 per treatment group, our study will still have at 

PROTOCOL TITLE:  
Patient and Provider Engagement and Empowerment through Technology  
(P2E2T2) to Improve Health in Diabetes 
 
 
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least 80% power to detect the specified clinically important effect size. We will not 
enroll more than 350 participants in total. 
 
 
Table 1: Sample size required to detect differences 
Difference in Self-
Efficacy Scores 
Significance Level 
(Alpha) 
Power (1-Beta) 
Intervention, N 
Control, N 
0.20 
0.05 
0.80 
219 
219 
0.25 
0.05 
0.80 
134 
134 
0.30 
0.05 
0.80 
92 
92 
0.35 
0.05 
0.80 
67 
67 
0.40 
0.05 
0.80 
51 
51 
 
8)  
Recruitment Methods 
 
We propose several approaches to accomplish our recruitment goals within the time 
frame of the funded study. These will be used in concert with one another to achieve the 
full sample.  
 
Potential study participants will be identified by a query of the Electronic Health Record 
(EHR) at UC Davis Health System for specific elements essential for eligibility (over age 
18; assignment to one of the participating primary care clinics & providers; diagnosis of 
Diabetes Mellitus-Type 2; and HgbA1C value of over 6.5 %). Affiliated clinic providers 
will be notified in advance that eligible patients from their census will be contacted for 
study participation. 
 
 
Mailed letters:  Potentially eligible patients (meeting the inclusion criteria) will receive a 
recruitment letter signed by the patient’s provider as well as a brochure that describes the 
study and explains that they can call the study line if they are interested, or that a research 
assistant will call them in the next few weeks to find out if they might be interested in 
participating in the study. Patients who do NOT want to be contacted about the study will 
be asked to return an enclosed opt-out card to the study office within 4 days of receiving 
the brochure. The opt-out card (attached) will be generic in that it will not identify the 
potential participant by name, but rather will have a coded number assigned by the 
research team, and will not note any health information or UC Davis affiliation to ensure 
their privacy.  In addition, it will provide a space for the individual to request that they 
not receive any additional solicitations for research participation by the institution.  A 
research assistant will only call patients who have not returned the opt-out card within the 
stated time period (3-4 weeks after letters mailed). Patients who express an interest in the 
study will be contacted by study staff to discuss their participation and to set up an 
appointment to sign the consent and receive the technology training (either intervention 
or usual care). Consenting participants meeting eligibility will be randomized to either 
Care Coordination or the P2E2T2 program.  
 

PROTOCOL TITLE:  
Patient and Provider Engagement and Empowerment through Technology  
(P2E2T2) to Improve Health in Diabetes 
 
 
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Telephone Calls placed to potentially eligible participants:  Research staff will screen 
patients for eligibility over the phone and set up an appointment to complete informed 
consent. Consenting participants meeting eligibility will be randomized to either Care 
Coordination or the P2E2T2 program. Patients who provide an opt-out card for 
participating will not receive any telephone call inquiring about their interest in 
participating in the study.  
 
Local recruitment:  A study coordinator and/or nurse health coach from the study will 
work with clinic staff and providers to identify potential participants by reviewing 
physician appointment schedules.  For these potentially eligible participants, recruitment 
and the consent process will be done in-person at the time of scheduled clinic 
appointments by CITI trained research staff or nurse coach with the provider’s approval.   
 
Practice alerts:  With the approval of clinics and providers participating in the study, the 
informatics team may initiate pop-up practice alerts when a potentially eligible patient is 
in the clinic for an appointment.  If the patient meets pre-set guidelines (over 18 years of 
age, diagnosis of Type 2 diabetes), an electronic alert in the EHR will appear that this 
patient may be eligible for a UC Davis Research study for the provider to review. The 
provider has an option of ignoring this alert or may briefly discuss that the patient may be 
eligible for a study and inquire if the patient would like further information.  If the person 
requests further information, the provider clicks a button that will send information to the 
study coordinator, so that a member of the research team can call the participant or meet 
with them in person to discuss the study. 
 
Advertisements: Participants will be recruited between January and August, 2016 through 
advertisements/flyers placed at participating clinics at local health systems. The flyers 
will provide information and describe the study as a Technology Enabled Support 
Program for Patients with Diabetes. 
 
Health Management and Education:  Trained study personnel may also promote 
recruitment for the trial by attending and describing the study to participants during 
diabetes education classes conducted at the UC Davis Center for Health Management & 
Education. The study will be presented as described and advertisements/flyers will be 
distributed. When study personnel are present, potential participants will be given the 
option to sign up to receive further information about the study. Participants may also be 
recruited directly through referral by local providers or Advisory Board Members.   
 
Randomization will be conducted through computer generated randomization using 
REDCap data management system.  This randomization will occur immediately 
following consent by computer generated randomization programming in Redcap.  The 
participant will then be assigned a study ID number which will be used to track all of 
their activity within the study (questionnaires, fitness tests, coaching sessions).  Only the 
study ID #, no personal identifiers, will be included on any of these study documents.  
 

PROTOCOL TITLE:  
Patient and Provider Engagement and Empowerment through Technology  
(P2E2T2) to Improve Health in Diabetes 
 
 
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Copies of recruitment flyers; provider letters; and informed consent documents are 
attached to this document.  
 
9) 
Compensation to the Subjects 
All subjects, regardless of treatment arm, will be given a health monitoring device at the 
end of the study. Upon completion of study questionnaire and their regularly scheduled 
visit with their primary care physician all participants will receive $50 at baseline, 3 and 
9 months. Those participants in the intervention (P2E2T2) arm will receive a health 
monitoring device at the beginning of the study; and those participants in the Care 
Coordination arm of the study will also receive a health monitoring device upon 
successful completion of all study questionnaires.  If participants do not complete all 
aspects of the study, they will not receive the health monitoring sensor device.  Each 
sensor device is worth approximately $75.  
  
 
10)  
Study Timelines  
Each individual will be enrolled in the study for 9 months.  Each participant will 
complete a study questionnaire at baseline, 3 months and 9 months.  Estimated 
duration of the study completion is 24 months from start of enrollment (January 1st, 
2016 – December 31st, 2017). 
 
11)  
Study Endpoints  
Outcomes to be evaluated include:  i) Quality of Life (QOL) measures; ii) Self-efficacy; 
iii) Readiness to Change; and iv) Clinically Relevant Indicators (HgbA1C, HDL, LDL, 
triglycerides).  All measures will be collected in both groups at the study timelines.  At 
baseline (time of recruitment), all participants will be asked to complete the surveys  and 
the care coordinator will request the primary care provider orders for the laboratory  tests 
measuring the clinical indicators.  The lab tests are routinely used to monitor diabetes 
management and are typically covered by insurance. Should the patient not have a 
payment source for the laboratory assays, the project will cover the cost of the laboratory 
tests. At 3 months and 9 months, surveys links will be sent by email to each participant 
along with a reminder to complete the laboratory work ordered by their provider.  If not 
completed, reminder emails or phone calls may be made by the study team. The primary 
endpoints of the study are: baseline data; data at the completion of five sessions of 
support calls during the 3 months of the intervention; and data at 6 months after the end 
of the intervention (9 months after baseline).   
 
12)  
Procedures Involved 
Usual Care:  Care Coordination through Health Management and Education: This 
program is a well-established program within the UC Davis Health System, providing 
care coordination to individuals with chronic conditions. Patients can self-refer or are 
referred by their providers for this service. The role of the care coordinator is to assess 
needs of the patient and coordinate healthcare referrals and appointments for the patient, 
facilitate communication among members of the healthcare team, identify health goals in 

PROTOCOL TITLE:  
Patient and Provider Engagement and Empowerment through Technology  
(P2E2T2) to Improve Health in Diabetes 
 
 
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collaboration with the patient and assist them in meeting those goals if requested by the 
patient. Contact is variable and conducted on a case by case basis. 
 
 
P2E2T2 Program  
The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach 
designed to elicit and support behavioral changes and improve self-efficacy (18-21).  
Nurses delivering the intervention will have completed the Health Science Institutes 
Registered Health Coach (RHC) training program (www.healthsciences.org).  The 
intervention protocol is as follows:  
 
 1.  The first phone call or videoconference contact with the RN health coach (30-
40 minutes): A personal and planning call for the participant and coach to 
discover the participant’s priority health issues and desired goals.  Conversation 
will explore barriers to addressing that issue, potential solutions to overcome 
barriers, and choices about types and frequency of activities.  
 
2.  Orientation to the technology (in person meeting): A member of the research 
team will meet with each participant to orient them to both the wireless health and 
fitness tracking sensor, other health applications and the mHealth dashboard in 
UC Davis’ Electronic Health Record, EPIC.  The selected sensors and 
applications will track numbers of steps traveled, approximate calorie expenditure 
based on movement, sleep quality, heart rate, and components of logged nutrition 
data. The data wirelessly uploads to the participant’s personal, or study supplied, 
Apple device (iPhone, iPad, or iPod), allowing the participant to develop 
awareness of typical activity and to work toward goals to improve activity levels.  
The mHealth platform/dashboard will allow the health coach and participant a 
secure space to share the data generated by the participant through the sensor, to 
view activity trends, and to create and track progress toward specific, measurable, 
attainable, relevant and time bound goals. Data elements shared to the electronic 
health record include: steps traveled, activities performed in minutes, calorie 
expenditure, and logged nutrition data. Participants can access  EPIC MyChart  
(web page/portal) through a smartphone, tablet, or personal computer.  The 
research team will provide individual training on the use of the technology. 
 
3.  Five bi-weekly support calls (15-30 minutes each; over 3 month intervention 
period): Calls will be scheduled at times chosen by the participant.  The purpose 
of these calls is to review progress and discuss approaches to solving problems in 
reaching goals.  On each call, the coach and participant will review the patient-
generated activity data from the sensors and compare in relation to goals.  They 
will observe and discuss trends in the data that may provide opportunities for 
reinforcement and highlight opportunities for continued behavior change. 
Following each session, the nurse coach will enter details about the current goal 
set by the patient, a snapshot of progress made toward goals and other relevant 
information into the mHealth Dashboard so that the patient, the provider and the 
nurse can all track and review progress. 

PROTOCOL TITLE:  
Patient and Provider Engagement and Empowerment through Technology  
(P2E2T2) to Improve Health in Diabetes 
 
 
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4.  Action Plan (at the completion of the fifth session): The participant and coach 
will summarize the goal chosen, progress made, and plans for follow-up.  Study 
staff will prepare a final form of the Action Plan and will send one copy to the 
participant and with their permission, one copy to their primary care provider with 
instructions to the primary care provider about recommended follow-up. 
Throughout the intervention, the performance of the certified health coaches will 
be monitored.  The project manager and study research personnel will record and 
review the health coaching conversations for quality assurance.  
 
For quality assurance purposes, participants will be asked if their coaching phone calls 
can be recorded for nurse training and education. The PI and research personnel will 
follow the UCD Media Authorization institutional policy for the use of recorded material 
for educational and training purposes that is outside the research. Digital recordings will 
be done with a handheld digital recorder, coded by assigned subject ID and coach ID and 
immediately uploaded to the research study’s password protected, secure drive on the 
UCDHS system server.  Upon upload to the secure drive, the recording will be deleted 
from the recording device.  This folder is accessible only by Improving Health in 
Diabetes research staff.  These recordings will be randomly selected for review and 
evaluation by the co-investigator on the study, Sheridan Miyamoto.  Feedback and 
training will be given to the health coaches based on the review of these recorded 
calls.  Recordings will be stored on the secure drive for five years and will then be 
destroyed.  
 
 
Questionnaires 
During initial orientation, at the conclusion of the intervention time period of 3months, 
and again at the 9 month follow-up date (6 months after completion of the intervention), 
subjects will be asked to complete the following questionnaires (estimated completion 
time 10-15 minutes each):  
1. Initial intake questionnaire (attached) - completed at baseline, beginning of study 
2. Follow-up questionnaire (attached) - completed at 3 months (completion of 
intervention) and 9 months follow-up date.   
The questionnaires will be available for in-person completion at baseline and 3 month 
follow-up.  The final 9 month survey will be sent securely using the REDCap data 
management system to the participant’s email address.  Participants may opt to complete 
the questionnaire on a written form if they prefer to do so.   
 
13)   
Data and Specimen Banking 
n/a 
 
14)   
Data Management and Confidentiality 
Data will be collected from participants at three time points:  1) baseline data at time of 
recruitment; 2) 3 months (coinciding with the program completion); and 3) 9 months 
(selected to assess sustained effects of the intervention).  At baseline, in addition to 

PROTOCOL TITLE:  
Patient and Provider Engagement and Empowerment through Technology  
(P2E2T2) to Improve Health in Diabetes 
 
 
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outcomes described in Table 2, all participants will complete a demographic survey 
which will include age, gender, race/ethnicity, education level, income level and 
insurance type and health history using the Charlson Comorbidity Index which includes 
common chronic conditions.  All data for the study will be collected by the research 
coordinator and entered into the REDCap (Research Electronic Data Capture) system 
housed in the servers managed by UC Davis Clinical and Translational Science Center 
(CTSC) (26).   
REDCap is a secure, web-based application designed to support data capture for 
research studies, providing: 1) an intuitive interface for validated data entry; 2) audit 
trails for tracking data manipulation and export procedures; 3) automated export 
procedures for seamless data downloads to common statistical packages; and 4) 
procedures for importing data from external sources. REDCap stores data on a secure 
server and eliminates any confidential information from being stored on personal 
computers.  Mental health diagnoses and treatment information will be directly entered 
into the REDCap database by the DHHS Quality Assurance Officer.  No materials with 
confidential information will be removed from the DHHS site.   
Nurse health coaching provided to the intervention group will have additional 
documentation related to the intervention and goal setting within an Epic module built 
for the project.  Progress notes from the nurse health coach interactions will be 
available for other members of the care team to access when working within a 
participant’s chart.  This element is essential as one of our aims is to determine if the 
presence of patient-generated sensor data and personal health goals within the EHR 
results in differences in diabetes related outcomes.   
 
Historical data, such as completed lab work values as identified above (Study 
Endpoints section), will be gathered by querying the EHR for all participants involved 
in the study.  This will be accomplished by working with the Health Informatics for 
research group, led by Kent Anderson. 
 
All data and data identifiers related to this study will be destroyed seven years after 
completion of the study. All data findings from the study will be presented as aggregate 
data with no individual subject identifiers. 
 
Subjects will be using commercial off-the-shelf (COTS) sensors, smart phone 
applications, and web-based physical activity dashboard technologies.   Participants must 
agree to use the sensors and applications required for data collection.  If they are 
unwilling to use this sensor, they will not be able to participate.  Immediately following 
consent and randomization into the “Care Coordination” and “P2E2T2” arms, project staff 
will assist participants with technology set-up, configuration, use, and ensure that 
subjects understand the commercial terms of service agreements, before they begin the 
trial. In order to further protect individual privacy, subjects in the P2E2T2 arm may choose 
to share with their coach only portions of the data streams from their devices/apps.  That 
is, subjects have the option to filter the data streams shared with their coach by time of 
day, and specific metric (i.e. steps counted, calories burned, etc.). 
 

PROTOCOL TITLE:  
Patient and Provider Engagement and Empowerment through Technology  
(P2E2T2) to Improve Health in Diabetes 
 
 
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Table 2.  Variables, Outcome Measures and Data Collection  
 
        Variable 
           Measure 
       Data Collection 
Baseline 
3 months 
9 Months 
Age, Gender, 
Race/Ethnicity, Education 
Level, Income Level and 
Insurance Type 
Demographic Data Form 
X 
 
 
Specific Aim 1 
Focus Groups 
 
 
X 
X 
X 
Specific Aim 2 
Self-Efficacy 
 
Diabetes Empowerment Scale – 
Short Form (DES-SF)  
X 
X 
X 
Readiness to Change 
Readiness to Change Survey 
X 
X 
X 
Clinical Indicators 
(Abstracted) 
Electronic health record 
X 
X 
X 
Quality of Life 
Patient Health Questionnaire 
depression scale-9 (PHQ-9) 
X 
X 
X 
Perceived Stress Scale (PSS) 
X 
X 
X 
PROMIS Measures – Physical 
Function SF, Emotional Distress 
SF, Sleep Disturbance 
X 
X 
X 
 
 
15)  
Provisions to Monitor the Data to Ensure the Safety of Subjects 
All subject questionnaires will be reviewed by the nurse researcher for the presence of 
mood symptoms that may require further assessment and possible intervention.  If a 
participant relates information to any of the study personnel that leads the study 
personnel to believe the participant is a risk to themselves or others, immediate 
consultation with the principal investigator (HY) will be obtained. The lead nurse 
investigator for this study, Heather Young, is qualified to monitor and quickly address 
high-risk behaviors observed and reported by the nurse coaches. Should a safety issue 
become apparent in the course of interacting with the participant, appropriate referrals 
will be made, the event will be documented, and if necessary the IRB will be notified. 
Appropriate referrals may be to crisis hotlines, the participant’s health care provider, or 
law enforcement as needed and deemed appropriate by the PI.  There is a minimal risk 
that a subject’s safety could be compromised by sharing historical data about activity. 
This risk is minimized with regard to this study, because only the intervening coach will 
have personal identifying information that links the participant with their coded activity 
data due to the personal and interactive nature of the coaching process.  Activity data that 
is analyzed and health coaching worksheets filled out by the coach will be coded and no 
personal identifiers will be available to the rest of the research team at the point of 
analysis. Due to the commercial availability of these apps, investigators cannot prevent 
study subjects from sharing their data with other individuals should an individual choose 
to share their data. 

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16) 
Withdrawal of Subjects 
Subjects may withdraw from the study at any time without harm or prejudice.  If the 
participant would like their data to be removed from the study, any data or paperwork 
related to the participant will be immediately destroyed. If they consent to allowing 
data already collected to be kept, this data may remain in the study.  
 
17)  Risks to Subjects 
There are little to no health risks associated with participation in this study and it is 
expected that participants receiving activity tracking and/or health coaching may receive 
some benefit. Increasing physical activity in incremental stages has known health benefits 
and low risk. The study does not involve diagnosis or treatment and targets health 
improvement rather than disease of a sensitive nature. There is possibility of loss of 
confidentiality, but appropriate steps will be taken to minimize those risks including 
coding of questionnaire and nurse coaching worksheets and maintenance of all data on 
secure, password protected servers. Additionally, subjects selected into one of the two 
treatment arms will be specifically counseled about potential losses of confidentiality 
relative to their use of commercial off-the-shelf (COTS) technology for health 
monitoring. What is learned may help improve diabetes care and diabetes management in 
general. For persons with sensitive skin, there is a slight risk that some of the assigned 
technology may cause skin sensitivity.  If this occurs, the participants will be advised to 
stop using the technology immediately, and contact the study team. Alternative 
technology will be provided to mitigate the problem if the subject choses to continue 
participating in the study. 
 
 
18) 
Potential Benefits to Subjects 
Subjects receiving feedback about their health behaviors through technology or 
technology plus health coaching may benefit from increased awareness of their daily 
habits. Subjects receiving health coaching may benefit from receiving individual 
counseling and support for healthy behavior change that encourages the adoption of 
healthy behaviors including dietary changes and physical activity.  Subjects receiving no 
intervention are not expected to benefit from this study. Subjects receiving the tech-plus-
health-coaching interventions may or may not benefit from their participation. 
 
19) 
Vulnerable Populations 
No vulnerable populations will be included in this study 
 
20) 
Multi-Site Research 
n/a 
 
 
21) 
Community-Based Participatory Research 
n/a 
 

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22) 
Sharing of Results with Subjects 
Once results have been analyzed, it is the intention of the research team to publish 
results and give public presentations about the aggregate outcomes of the study.  All 
participants will be notified of publications stemming from the research as well as any 
public presentations on the UC Davis campus. 
 
23) 
Setting 
The orientation, questionnaire answering, and technology training will be conducted at 
a specified location at the participating clinics, where the patient obtains their routine 
care.  There are numerous small and large conference rooms available to conduct all 
aspects of the intervention orientation and testing.  Nurse health coaching sessions will 
be conducted over the phone, at times convenient to the participant.  
 
24) 
Resources Available 
Appropriate resources and funding are in place to conduct this study. Questionnaire 
administration and technology orientation will occur in-person at the clinic in which 
the participant receives their primary care services (see #23 above).  
 
Personnel include: 
 
PI and Co-Investigators:  Responsible for overseeing the various aspects of the 
project:  technology, recruitment, required training, nurse coaching, data analysis, data 
safety and management, IRB compliance, etc.   
Health Coach: certified in Motivational Interviewing (MI) and trained to conduct 
initial intake and ~15 hours/week of health coaching and study administration. The 
Health Coach will have previous experience coordinating research trials and familiar 
with UCD IRB requirements. 
Project Manager: The Project Manager has previous experience coordinating 
research trials and familiar with UCD IRB requirements. She will participate in 
recruiting subjects, screening, consenting, scheduling, and communicating along with 
the preparation and conduction of research procedures. 
Junior Specialist:  Will be supervised by one of the Co-investigators.  The Jr. 
Specialist will be involved in scheduling orientations, procuring rooms for activities, 
recruitment, and data collection as well as providing technology on-boarding for 
participants and on-going technical support.   He/She is familiar with UCD IRB 
requirements. 
 
Patient Advisory Board Members: As part of the PCORI funding expectations, this 
project includes three Advisory groups: Patients, Providers and Technical/Computer 
Experts. The Patient Advisory Board provides input and guidance to the study team 
about study design, measures, recruitment strategies, and will assist in interpreting de-
identified data. Several patient advisors have indicated interest in assisting with 
recruitment, and have offered to go to clinics to help recruit participants. Those 
interested will complete CITI training and will receive all appropriate training as 
members of the research team, and will be added to the research personnel list, before 
engaging in any direct contact with participants or data.  

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We anticipate, with increased advertising of this project, we can enroll 30 participants 
a month.  This means total enrollment would take approximately 6 months.   
 
Significant research staff time will be devoted to conducting this research. The Project 
Manager has 75% time devoted to the execution, completion, and analysis of this 
research.  Two health coaches will be hired at 75% time over a 12 month period to 
accommodate the extent of health coaching required during a rolling enrollment over 6 
months.  
 
25) 
Prior Approvals 
n/a 
 
26)  Provisions to Protect the Privacy Interests of Subjects 
The study staff will offer detailed explanation of the study to subjects prior to consent.  It 
will be emphasized that all of the data collected in the study will be de-identified.  All 
results will be analyzed in aggregate.   It will be stored in a secure server and used 
expressly in de-identified form exclusively for the purposes of the aims of this research 
project.  
 
Following consent, participants will be randomized and receive a study identification 
number.  This number will be entered into the secure REDCap database on a tablet.  The 
participant will be offered the questionnaire on either the tablet with their unique study 
identification shown at top.  Their name and other unique identifiers will not be asked 
during the survey.  If the participant would prefer to fill out the survey on paper, the same 
procedure will be followed and research staff will transcribe the survey into REDCap.   
Clinical and lifestyle (physical activity, nutrition, sleep) data will be stored in their 
clinical record (EPIC Hyperspace) which is HIPAA protected. Clinical data in their 
record may be viewed by their treating physicians and clinical team as part of standard 
care at UC Davis Health System. Including this lifestyle data in the clinical record will 
promote a wellness conversation and foster collaboration between diabetes patients and 
primary care providers. 
 
All data stored by UC Davis researchers will have all personal identifiers removed and 
labeled with participant’s study identification number. All electronic data will be stored 
on a password protected server that is accessed only by study personnel. All paper data 
will be stored in locked cabinets in a room with access limited to research personnel. 
 
 
27) 
Compensation for Research-Related Injury 
This research involves only minimal risk to subjects.   
 
In the event a patient suffers an injury as a result of participating in this research study, 
the University of California will provide necessary medical treatment. Depending on the 
circumstances, the costs of the treatment may be covered by University or the study 

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sponsor or may be billed to the patient’s insurance company just like other medical costs. 
The University and the study sponsor do not normally provide any other form of 
compensation for injury. 
 
28) 
Economic Burden to Subjects 
There are no other monetary costs to participate in the study.  All technology costs will 
be covered by the study except if a participant uses their personal smart-phone or 
computing technology to visualize data collected by the provided activity sensors.   
This cost is one that the participant was already incurring.  If they do not have a 
personal computing device compatible with the sensor technology, one will be 
provided without cost for the duration of the study. 
 
29) 
Consent Process 
Patients who are interested to participate in the study or are referred by their primary care 
provider will receive an initial telephone call to conduct the pre-screening assessment 
(see attached document) to determine if they are eligible to participate in the study. If 
someone is determined to be eligible, an appointment will be scheduled to consent the 
patient. During the consent process, the study will be described to potential participants. 
A member of the research team will describe the study, what is required of the 
participant, study procedures and answer any questions the potential participants may 
have. If the subject would like to take time to consider participation, they will be offered 
an intake date in the near future. 
   
Following consent using the Informed Consent Document (see attached), subjects are 
enrolled in the study and randomized into one of two study arms.  Subjects will have the 
choice of receiving a hard copy of their signed consent form or receive the form by email. 
They will then be administered initial surveys.  
 
A study telephone line is available to allow participants to reach the Project Manager 
with any concerns regarding ongoing consent or participation.   
 
 
30) 
Process to Document Consent in Writing 
The research team will follow the “SOP: Informed Consent Process for Research (HRP-
090)” (attached) to consent participants. 
 
31) 
Drugs or Devices  
n/a 
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