Clinical trial NCT02488785: Impact of a Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With T2 Diabetes
Official title: The Impact of a Comprehensive Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Telehealth
Hispanics
Latinos
Self-Care
Mobile Health
mHealth
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Verizon Foundation
name: DHR Health Institute for Research and Development
First posted: 2015-07-02
Enrollment: 96
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.)

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburg
country: United States
facility: Doctors Hospital at Renaissance
state: Texas
Study officials:
affiliation: Joslin Diabetes Center
name: Sylvia E Rosas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Doctors Hospital at Reinassance
name: Marcel Twahirwa, MD
role: PRINCIPAL_INVESTIGATOR
References: