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Impact of a Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With T2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02488785
Recruitment Status : Completed
First Posted : July 2, 2015
Last Update Posted : August 20, 2018
Sponsor:
Collaborators:
Verizon Foundation
Doctors Hospital at Renaissance
Information provided by (Responsible Party):
Joslin Diabetes Center

Brief Summary:
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. The investigators 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Virtual Diabetes Self-Care and Education Program Device: Fitbit Device: Smartphone Not Applicable

Detailed Description:
In this study participants will be followed for a period of 9 months. The control group will receive usual care during this period of time. While, the intervention group will be part of a diabetes education and management program lasting 6 months via a smartphone participants will receive. The 6 month intervention will be followed by a 3 month observation period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of a Comprehensive Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With Type 2 Diabetes
Actual Study Start Date : June 2015
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care.
Experimental: Intervention
Patients in this group will be part of a Virtual Diabetes Self-Care and Education Program. They will receive a phone to communicate with a diabetes educator for 6 months. They will connect with the diabetes educator for weekly video conferences of up to 30 minutes for twelve consecutive weeks, followed by 7 phone calls. Additionally, they will receive a weekly text message about diabetes for 6 months.
Behavioral: Virtual Diabetes Self-Care and Education Program
Participants will be able to have frequent contact in order to share physical activity and glucose data with the diabetes educator using the smartphone they will receive. Information downloaded to the Glooko Population Management tool can be shared with the diabetes educator.

Device: Fitbit
Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the diabetes educator using the device's smartphone application.
Other Name: physical activity tracker

Device: Smartphone
All virtual visits were performed via provided smartphone. In addition, participants will receive a Glooko MeterSync Blue cable which is able to connect to most glucose meters in order to download glucose data to the Glooko Population Management tool on their smartphones




Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 9 months ]
    The A1C test is a blood test used to diagnose type 2 diabetes and then to manage diabetes. It is measured as a percent.


Secondary Outcome Measures :
  1. Number of participants who adhere to medications [ Time Frame: 9 months ]
    Evaluated using the Morisky Medication Adherence Scale

  2. Number of participants with diabetes related emotional distress [ Time Frame: 6 months ]
    Evaluated using the Problem Areas in Diabetes Questionnaire (PAID)

  3. Number of participants with adequate self-care [ Time Frame: 9 months ]
    Evaluated using the Self Care Inventory - Revised (SCI-R)

  4. Number of participants with depression [ Time Frame: 6 months ]
    Evaluated using the Patient Health Questionnaire - 9 (PHQ-9)

  5. Number of participants with anxiety [ Time Frame: 6 months ]
    Evaluated using the Generalized Anxiety Disorder - 7 (GAD-7)

  6. Number of physically active participants [ Time Frame: 9 months ]
    Assessed using a physical activity tracker



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have physician-diagnosed type 2 diabetes
  • Be self-identified as Hispanic or Latino
  • An A1c value between 8-14% within the last three months.
  • 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

Exclusion Criteria:

  • Severe diabetes related chronic complications such as chronic renal failure, blindness, amputations, stroke, etc.
  • Concomitant chronic illnesses that would affect their participation in the program, i.e. cancer, debilitating diseases, etc.
  • Any other condition that would affect participant's basic mental health skills
  • Type 1 diabetes or gestational diabetes
  • 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
  • Signs or symptoms of metabolic decompensation (polyuria, polydypsia, polyphagia, unexplained weight loss, blurry vision, lethargy, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488785


Locations
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United States, Texas
Doctors Hospital at Renaissance
Edinburg, Texas, United States, 78539
Sponsors and Collaborators
Joslin Diabetes Center
Verizon Foundation
Doctors Hospital at Renaissance
Investigators
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Principal Investigator: Sylvia E Rosas, MD Joslin Diabetes Center
Principal Investigator: Marcel Twahirwa, MD Doctors Hospital at Reinassance
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Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT02488785    
Other Study ID Numbers: 2014-42
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Keywords provided by Joslin Diabetes Center:
Type 2 Diabetes Mellitus
Telehealth
Hispanics
Latinos
Self-Care
Mobile Health
mHealth
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases