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Impact of a Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With Type 2 Diabetes Mellitus

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Verizon Foundation
Doctors Hospital at Renaissance
Information provided by (Responsible Party):
Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT02488785
First received: June 4, 2015
Last updated: March 8, 2017
Last verified: March 2017
  Purpose
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 Intervention
Type 2 Diabetes Mellitus
Behavioral: Virtual Diabetes Self-Care and Education Program
Device: Fitbit
Device: Smartphone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 9 months ]

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

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

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

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

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

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


Enrollment: 107
Study Start Date: June 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 share physical activity and glucose data with the diabetes educator using the smartphone they will receive. 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. 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. Information downloaded to the Glooko Population Management tool can be shared with the diabetes educator.
Device: Fitbit Device: Smartphone

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.
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02488785

Locations
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
Principal Investigator: Enrique Caballero, MD Joslin Diabetes Center
Principal Investigator: Marcel Twahirwa, MD Doctors Hospital at Reinassance
  More Information

Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT02488785     History of Changes
Other Study ID Numbers: 2014-42
Study First Received: June 4, 2015
Last Updated: March 8, 2017

Keywords provided by Joslin Diabetes Center:
Type 2 Diabetes Mellitus
Telehealth
Hispanics
Latinos
Self-Care
Mobile Health
mHealth

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on March 28, 2017