Technology Intensified Diabetes Education Study in African Americans

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
State University of New York at Buffalo
Study ID
NCT02088658
Status
Completed

Conditions

  • Diabetes Mellitus, Adult-Onset
  • Diabetes Mellitus, Non-Insulin-Dependent
  • Diabetes Mellitus, Noninsulin Dependent
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type II

Eligibility Criteria

Sex
ALL
Age
21 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Technology Intensified — BEHAVIORAL
    The intervention is based on the Information-Motivation-Behavioral Skills (IMB) model and provides information, motivation, and behavioral skills training (using motivational enhancement techniques). Patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. They will be asked to perform glucose testing and blood pressure measurement using the FORA system once daily. They will be asked to upload the measurements daily as soon as possible after the test is performed. The nurse educators will have access to a secure server to which the uploaded measurements are stored in real time. The glucose and BP readings will be used to tailor and reinforce behavior change during weekly telephone-delivered diabetes education sessions.

Study Details

The purpose of this study is to test the usefulness of an intervention that combines technology with diabetes education and skills training. This study has been designed specifically for African Americans with poorly controlled type 2 diabetes.

Key Dates

Start date
May 31, 2013
Status verified
Feb 2026
Primary completion
Dec 31, 2021
Completion
Jan 31, 2026

Study Design

Enrollment
200 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Techonology Intensified
    Subjects randomized to this group will receive: 1) the FORA system for self-monitoring; 2) weekly telephone-delivered diabetes education/skills training; 3) patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions); and 4) patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools). The intervention will be delivered by telephone once a week for 12 weeks with each session lasting \~30 minutes.
  • No Intervention: Usual Care
    Apart from study visits, patients will be followed by their primary care providers. The provider will be responsible for determining treatment parameters, making changes in the treatment regimen, and determining the timing of follow up visits. Between scheduled office encounters, contact between patient and provider will be patient initiated. The provider may use clinic nurses to follow up on problematic patients or patients with abnormal results. In essence, this group will receive the current standard of care at the study clinics.

Primary Outcome Measure

Hemoglobin A1c [ Time Frame: 12 months post randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425-

Find similar trials in Charleston, SC

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Medical University of South Carolina· Charleston, SC

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