The Impact of a Comprehensive Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With Type 2 Diabetes
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Sponsor: Joslin Diabetes Center

 
Impact of a Virtual Diabetes Self-Care and Education Program 
on Diabetes-related Outcomes in Latinos with T2 Diabetes 
 
 
NCT02488785 
 
 
 
Document date Oct 27/2015 

Study Protocol 
1 
 
 
PROGRAM DESCRIPTION/PLAN OF OPERATION 
PURPOSE OF PROTOCOL: 
 
The goal of this study is to evaluate the impact of a comprehensive diabetes education 
and management program based on frequent communication with patients using 
teleconsultation, text messaging, and phone calls on diabetes related outcomes in Latino 
patients with type 2 diabetes. We hypothesize that the decline in hemoglobin A1c value 
between the baseline and the six-month visit will be at least 0.5 percent greater in the 
intervention group than in the control group.  
 
 
1. Objectives: 
a. Improve adherence to nutritional therapy, physical activity, glucose monitoring 
and medication use in Latino patients with type 2 diabetes by using a virtual 
diabetes education and self-management program in a six month period and in 
comparison to usual diabetes care and education received in diabetes clinics.  
b. Improve A1c levels, blood pressure, lipids and weight control in Latino patients 
with diabetes using this program within the same time frame. 
c. Improve adherence to clinic appointments and decrease diabetes related stress, 
depression, visits to the emergency room and hospitalizations with the use of this 
program in comparison to people receiving usual diabetes care.   
d. Evaluate the impact of each of the three components of the program 
(teleconsultations, text messaging and phone calls) on the adherence to basic 
diabetes self-care behaviors. 
 
2. Activities: 
 
Setting: 
Joslin Affiliated Center at Doctor’s Hospital at Renaissance in Edinburg (DHR), TX. 
 
Duration: 
18 months total: 
1. 3 months for IRB approval and training at the partner site 
2. 12 months of continuous enrollment (including 9 months of study) 
3. 3 months of data analysis and manuscript preparation 
 
Protocol:  
 
Inclusion Criteria: 
In order to participate in the program, all patients must meet the following criteria: 
 
1. Have physician-diagnosed type 2 diabetes 
2. Be self-identified as Hispanic or Latino 
3. Age 21 to 80 
4. An A1c value between 8-14% within the last three months.  
5. Demonstrate the ability, either alone or with the help of a family member that will be with 
the patient at least once a week, to use the technology that will be used during the 
teleconsultations.  

Study Protocol 
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Exclusion Criteria: 
Subjects will be excluded if they have any of the following conditions: 
 
1. Severe diabetes related chronic complications such as chronic renal failure, blindness, 
amputations, stroke, etc. 
2. Concomitant chronic illnesses that would affect their participation in the program, i.e. 
cancer, debilitating diseases, etc. 
3. Any other condition that would affect participant’s basic mental health skills. 
4. Type 1 diabetes or gestational diabetes. 
5. Patients with abnormal hemoglobin, anemia or any condition that may affect red blood 
cell turnover.  Any of these conditions may be detected through participants’ history or 
through the laboratory report at study screening. 
6. Signs or symptoms of metabolic decompensation (polyuria, polydypsia, polyfphagia, 
unexplained weight loss, blurry vision, lethargy, etc.) 
 
Elimination Criteria:  
Development of any acute event during the study period that would affect participants’ primary 
outcome at the discretion of the investigator, e.g. hyperosmolar coma, acute event of significant 
hyperglycemia or the use of certain medications like steroids. 
 
Groups:    
A total of 92 participants will be randomly assigned to one of the two study groups: 
 
Group 1 – Intervention group – this group will complete activities described above. During 
scheduled follow-up clinical visits at months 3, 6, and 9, an additional A1c will be obtained.  All 
measurements will be covered through the study grant if the patient does not have a recent 
laboratory result (2 weeks prior to the study visit) for the following test: A1c, lipid panel, ALT, 
AST, microalbumin, and chem 6 result. 
 
Group 2 - Control Group –  
This group will attend regular visits with their medical and education providers. As in the 
intervention group, these visits are expected to occur at 3, 6, and 9 months after the first visit.  
This group corresponds to the usual care that is provided at DHR. 
 
Primary Outcome: 
The primary outcome variable will be the change in hemoglobin A1c value from baseline to 6 
months. 
 
Sample Size: 
We hypothesize that the decline in hemoglobin A1c value between the baseline and the six-
month visit will be at least 0.5 percent greater in the intervention group than in the control group.  
 
The sample size and power calculation is based on preliminary results of our study where the 
study aimed at behavioral change.   Assuming a mean reduction of 0.504 (SD= 1.2) in A1c  in 
the  intervention group and no change in the control group a sample size of 37 per group will be 
needed to detect  this reduction with 80 % at 5% level of significance (one-sided) using the t-
test.  Assuming a 20% dropout, 46 study subjects per group (total 92) will be needed.   
 
Recruitment: 

Study Protocol 
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Study candidates will be identified at the partner site (DHR) where this protocol will take place.  
This will be done by creating flyers, videos, print and web-based ads, and letters to invite 
patients that attend the practice to join the study and/or by directly inviting patients that regularly 
attend the practice.   Proper informed written consent will be obtained from all individuals prior 
to participation in the study.  
 
Interventions: 
 
 
a. Virtual diabetes self-management group 
i. Weekly conversations led by the diabetes educator (30-minute) using 
teleconsultation to deliver diabetes education and enhance adherence to 
treatment recommendations. These conversations will occur during the 
first 12 weeks of the intervention and will consist of the following 
elements:  a) open question as to whether there is a particular item for 
discussion that the patient would like to address; b) review of blood 
glucose and physical activity results; c) review of the adherence to the 
four basic self-care behaviors (meal plan, physical activity, glucose 
monitoring and medications); d) identification of barriers to adhere to 
treatment recommendations; and e) provision of specific 
recommendations to overcome identified barriers.   In order to provide 
diabetes education in a culturally and linguistically oriented manner, 
particularly to those patients with low health literacy, all participants in the 
virtual education program will be encouraged to listen to Rosa’s or Jose’s 
Story during the first 8 weeks of the intervention. These are audio-
novellas developed by the Latino Diabetes Initiative at Joslin Diabetes 
Center to educate Latino patients with type 2 diabetes using the story 
telling method in a practical and engaging manner.  
ii. Since the teleconsultations will only last 12 weeks, phone conversations 
with the diabetes educator will be implemented starting in the 4th month of 
the program.  These will be 15-30 minute conversations and will occur at 
weeks 14, 15, 16, 17, 19, 21, and 23. The goal of the phone calls is to 
provide support to the patients and they will follow the same protocol as 
the weekly conversations described above.  
iii. A weekly text message will be sent to patients during the 6 months of the 
education program. These messages will focus on assessing and 
addressing participants’ beliefs about common myths and misconceptions 
in the area of diabetes.  The text message will present the myth of the 
week and request people’s participation in responding whether the 
concept is true or false and will also provide the correct answer to the 
question presented the prior week.    
iv. Observation period: the third quarter of the intervention (months 6-9) will 
allow the observation of the residual effect of the virtual education 
program; therefore no contact or education will be planned for the last 3 
months (months 7, 8 & 9).  Patients will be followed in their corresponding 
clinics as usual.    
   
 
b.   In-person diabetes self-management education or control group 
i. Patients in this group will attend their regular clinical and education 
appointments as offered by the center.    

Study Protocol 
4 
 
 
 
 
 
 
 
 
The table below presents the timeline for the interventions discussed above. 
 
 
 
Months 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Virtual 
education 
4w 
R/J 
4T 
4w 
R/J 
4T 
4w 
 
4T 
4p 
 
4T 
2p 
 
4T 
1p 
 
4T 
 
 
 
 
W=weekly teleconsultation 
P=Phone conversation 
R/J=Rosa or Jose’s Story 
T=Text message related to a diabetes myths and misconceptions 
 
 
Study Procedures: 
 
Before randomization, all participants will go through the following steps: 
 
1) Eligible patients will have their standard follow-up clinical encounter with their 
corresponding health care provider.     
2) Screening visit.   At this time, the research assistant or study coordinator will obtain the 
baseline A1c measured through each site’s laboratory and will review inclusion and 
exclusion criteria with study candidates to assess eligibility for the study. If the patient 
qualifies for the study, clinicians will not be aware of this at the time of the initial visit, so 
that this value does not influence their treatment at baseline and the intervention is left 
as the main explanatory variable.    
 
After the regular clinical visit and the screening visit the eligible participants will be 
randomized to one of the two groups. 
 
After randomization, participants will go through the following steps: 
 
3) All participants in the study will receive a healthy eating handout, pedometer with 
exercise handout, and pillbox and will be invited to come to the center for an initial 2-
hour nutrition and exercise recommendation group session taught by the diabetes 
educator. The research assistant and/or study coordinator will provide these items and 
book to patients that want to participate in the group session. 
 
4) Participants in the intervention group will receive education and training on how to 
operate the technology as well as copies of Rosa’s or Jose’s Story in their preferred 
language and based on their education needs.  A calendar with specific dates and times 
for their weekly/monthly interaction with the diabetes team will be provided to 
participants.   

Study Protocol 
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5) All study participants will be given a follow-up appointment 3, 6, and 9 months after the 
baseline visit.  
 
 
 
 
 
Project related materials:  
 
 
Patient Education:  
At baseline, all patients in the study will have the opportunity to come to the center for initial 2-
hour nutrition and exercise recommendation group session.  They will receive handouts 
regarding food, exercise, medication and will emphasize the need to take medications and 
insulin on time, follow meal plans, be physically active and monitor blood glucose levels as 
recommended by their health care provider.   This information will be available in English and 
Spanish and will be based on culturally oriented materials for Latino patients with low/medium 
health literacy. 
 
Resources for Providers: 
All providers will receive training and log-in information for the teleconsultation.  
 
The partner site will receive Patient Education Handouts (in English and Spanish) that 
providers can use whenever necessary to support changes to treatment plans for study 
participants.  For instance, handouts on how to start and advance insulin therapy will be 
provided.  Information on other pharmacologic interventions will also be available. Providers will 
have access to the electronic versions of all handouts 
 
Patient Incentives: 
Each participant will receive $35 every time they complete a study visit. Participants will be 
asked to complete four study visits in a period of nine months.   
 
Study Visits: 
Before any study procedure is done, the patient will be asked to read the consent form. A 
member of the study staff will discuss the study and the study procedures.  Additional time from 
participants’ regular clinical appointments will be necessary to collect study related information 
as follows: 
 
Visit 1: This visit will last 60 minutes and will start by obtaining an A1c value to verify patient’s 
eligibility. After a patient has been enrolled in the study (A1c value between 8-14%) they will be 
randomly assigned to the control or intervention group (virtual diabetes self-management 
education program using teleconsultation) and baseline information will be collected. 
Participants in the intervention group will be trained to use technology related to the 
teleconsultation, their own glucometer and the pedometer administered by this program.   
 
Visit 2: This visit will last 60 minutes for questionnaires and will be completed 3 months after 
visit 1. All the tests and questionnaires detailed in table 1 will be administered at this visit. 
 
Visit 3: This visit will last 60 minutes for questionnaires and will be completed 6 months after 
visit 1. All the tests and questionnaires detailed in table 1 will be administered at this visit. 

Study Protocol 
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Visit 4: This visit will last 60 minutes for questionnaires and will be completed 9 months after 
visit 1. All the tests and questionnaires detailed in table 1 will be administered at this visit. 
 
 
 
 
 
Timeline Table for Study Procedures:  
 
Study Variables (both groups) 
Baseline Visit 
3 
6 
9 
Laboratories 
 
 
 
 
Blood drawn 
x 
x 
x 
x 
A1c 
x 
x 
x 
x 
Lipid profile 
x 
x 
x 
x 
ALT (from patient record if available) 
x 
x 
 
x 
AST (from patient record if available) 
x 
x 
 
x 
Microalbumin (from patient record if available) 
x 
 
x 
x 
Chem 6 (from patient record if available) 
x 
x 
 
x 
Measurements 
 
 
 
 
Weight 
x 
x 
x 
x 
Height 
x 
 
 
 
Blood pressure 
x 
x 
x 
x 
Questionnaires 
 
 
 
 
Demographic characteristics  
x 
 
 
 
Diabetes history  
x 
 
 
 
Diabetes treatment plan 
x 
x 
x 
x 
Adherence to prescribed drugs 
x 
x 
x 
x 
Measures of emotional distress (depression, 
anxiety and PAID) 
x 
 
x 
 
Health literacy 
x 
 
 
 
Self-care behaviors 
x 
x 
x 
x 
Executive function  
x 
 
 
 
Depression scale 
x 
x 
x 
x 
Physical activity: pedometer use and number of 
steps per day 
x 
x 
x 
x 
24 hour recall  
x 
x 
x 
x 
Food frequency questionnaire  
x 
x 
x 
x 
Analysis of the photo of the content of the 
refrigerator (only for the intervention group) 
x 
x 
x 
x 
 
 
IRB: 
The Joslin Diabetes Center’s Institutional Review Board will be in charge of approving this 
protocol according to current clinical research guidelines. 
 

Study Protocol 
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An informed consent for participation in the study will be generated to be approved by the IRB.   
This consent form will be given to all participants before the study begins.  Only participants that 
have given full written consent will be able to participate in the study.     
 
Adverse Events: 
We don’t anticipate any serious adverse events as this is a study that does not involve the use 
of any major procedure or the use of any pharmacologic intervention.  The only potential 
adverse events are those related with answering questionnaires or drawing blood for the A1c 
test and other laboratories specified above.      
 
 
Good Clinical Practice: 
Whereas the primary objective of the protocol is to assess whether there is a significant 
difference in glycemic control with teleconsultations with the diabetes team at the patient’s 
home, all participants in the study regardless of the assigned study group will be offered the 
best possible diabetes care according to current standards and approved treatment algorithms, 
particularly the recently published American Diabetes Association standards. 
 
If at any point in time during the study, the investigators or practicing clinicians consider that it 
would be in the patient’s best interest to terminate their participation in the study; this will be 
considered a priority.  
 
 
Process and product study variables: 
 
Primary outcome:  
 
 
A1c levels:  
The values obtained through the laboratory at each of the participating sites will be used to 
evaluate the primary outcome of the study. The baseline A1c value will be used for eligibility for 
the study.   
 
 
Other variables:  
 
 
Demographic characteristics (obtained at baseline) 
The demographic variables of interest are: date of birth, years in the practice, household status 
(living with one or more persons, living alone), years of education, socioeconomic status, 
community of residence and insurance status. 
 
 
Diabetes history (obtained at baseline) 
The variables of interest are: date of diagnosis, age at diagnosis, years with diabetes, family 
history of diabetes, diabetes specialist care and history of diabetes education.   
 
 
Diabetes treatment plan (obtained at baseline and during each clinical encounter in 
both groups and during the teleconsultations and telephone communications in the intervention 
group)  
o Current meal and exercise plan  
o Diabetes treatment (oral medications, injected medication, insulin) 

Study Protocol 
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o Glucose monitoring patterns (number of self-measured blood glucose (SMBG) 
per day and per week), use of logbook, barriers to SMBG, pre- and post-prandial 
glucose values.   
 
 
General Medical Evaluation (obtained at baseline and at every visit) 
This evaluation will include: weight and height to calculate body mass index (BMI), waist 
circumference, blood pressure, capillary glucose level, A1c, smoking habits, aspirin therapy, last 
eye exam, last microalbumin test, last appointment with an educator, last dental exam and other 
co-morbidities affecting A1c results.  
Lipid Profile: practice will be encouraged to measure lipid profile throughout the study.  
 
 
 
Adherence to prescribed drugs: 
Medication adherence will be measured through the use of a validated questionnaire called the 
Morisky Scale. 
 
 
Measures of emotional distress (will be completed at baseline and last visit) 
The Problem Areas in Diabetes (PAID) scale is a well-used and validated tool for measuring 
diabetes-related distress. The questionnaire has statistically significant power to predict 
diabetes control in long-term studies. More importantly, the self-reporting tool has been used to 
study people living with type 2 diabetes in the Latino community. Welch et al. reported a 
Cronbach’s alpha coefficient of .95 in a study evaluating its usefulness in clinical settings. (9) 
 
 
Health literacy: (will be assessed at baseline) 
Each of the participants will be assessed using the Newest Vital Sign (NVS) instrument. (10)  
 
 
Self-care behaviors: (will be completed at every visit) 
We will use the Self-Care Inventory-Revised to measure behavioral changes among patients. 
This 19-question validated scale measures the subject’s perception of the frequency of 
diabetes-specific tasks performed over the past 1-2 months, such as blood testing, exercising, 
adherence to medication, and healthy eating. Research supports reliability of the scale in people 
living with type 2 diabetes. Also, the scale supports an inverse relationship between glycemic 
control and the mean score of the SCI-R. Weinger et al. reported a Cronbach’s alpha coefficient 
of .87. (11) 
 Depression scale (will be completed at baseline and 6-month visit) 
We will use the Patient Health Questionnaire-9 (PHQ-9). This measure has nine items, 
each of which is scored, providing a 0 to 27 severity score. 
 
 Anxiety scale (will be completed at baseline and 6-month visit) 
We will use the Generalized Anxiety Disorder-7 (GAD-7). This measure has nine items, 
each of which is scored, providing a 0 to 21 severity score. Scores of 5, 10, and 15 are 
taken as the cut off points for mild, moderate, and severe anxiety, respectively. When 
used as a screening tool, further evaluation is recommended when the score is 10 or 
greater 
 
 Refrigerator photo (obtained at baseline and at every visit) – intervention group 
only 
All participants in the intervention group will be asked to take a photo of their refrigerator 
using the camera in their smart phones. The study team will receive these images and 

Study Protocol 
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they will be analyzed to see the proportions of package food versus non-package foods 
present in each picture.  
 
 24 Hour Food Recall (will be completed at every visit)  
All participants will be asked to recall what they ate on two days prior to the recruitment 
visit and one day at the 3, 6, and 9 month visits.  
 
 Physical activity (will be obtained at every visit)  
All participants will be given a Fitbit physical activity tracker. Data recorded by the 
device will be downloaded at each study visit. In addition, intervention patients who wish 
to share the data with the diabetes educator can download the data at any time using 
the phone they will receive.  
 
 Glucose log (will be obtained at every visit) 
Glucose monitor data for every patient will be downloaded at each visit using the 
Glooko MeterSync Blue cable which is able to connect to most glucose meters and 
download data to the Glooko Population Management tool. Intervention patients will 
receive a cable to sync their meters at home using the phone they receive if they 
choose to share the information with their diabetes educator.