Trial record 1 of 8837 for:    diabetes
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Technology Intensified Diabetes Education Study in African Americans (TIDES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Medical University of South Carolina
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT02088658
First received: March 13, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
Diabetes Mellitus, Non-Insulin-Dependent
Diabetes Mellitus, Noninsulin Dependent
Diabetes Mellitus, Type II
Behavioral: Technology Intensified

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Technology Intensified Diabetes Education Study in African Americans With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 12 months post randomization ] [ Designated as safety issue: No ]
    Hemoglobin A1c (HbA1c): blood specimens will be collected at the screening visit, as well as the 3-months, 6-months, 9-months, and 12-months follow-up visits


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: 12 months post randomization ] [ Designated as safety issue: No ]
    Blood pressure measurement: Blood pressure readings will be obtained at baseline, 3-months, 6-months, 9-months, and 12-months, following the American Heart Association guidelines. The device will be programmed to take 3 readings at 2 minute intervals, and give an average of the 3 blood pressure readings.

  • Quality of Life [ Time Frame: 12 months post randomization ] [ Designated as safety issue: No ]
    Quality of Life: The Short Form-12 (SF-12) is a valid and reliable instrument to measure functional status. The SF-12 items reproduce at least 90% of the variance in physical component (PCS-36) and mental component (MCS-36) scores.

  • Resource Utilization & Cost [ Time Frame: 12 months post randomization ] [ Designated as safety issue: No ]
    Resource Utilization & Cost: Information on hospitalizations, physician/professional visits, and medications will be captured.


Estimated Enrollment: 200
Study Start Date: May 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Technology Intensified
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.
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.

Detailed Description:

African Americans (AA) with type 2 diabetes (T2DM) have higher prevalence of diabetes, poorer metabolic control (i.e. poorer blood glucose, blood pressure, and lipid control), and greater risk for complications and death compared to White Americans. Hemoglobin A1c (HbA1c) is the primary marker for glycemic control and is a strong independent predictor of development of complications and increased mortality in T2DM. Key self-care behaviors that influence glycemic control (and HbA1c) include diet, physical activity, self-monitoring of blood glucose and medication adherence. Systematic review of multiple randomized clinical trials (RCTs) show that self-care interventions that include diabetes education and skills training are effective in improving metabolic control in diabetes. Recent findings indicate that patients with diabetes, especially ethnic minority patients, prefer telephone-delivered diabetes education to group visits or internet-based education. Multiple RCTs have documented the effectiveness of telephone-delivered self-care interventions in T2DM. Preliminary data from our group also suggest that a culturally-tailored telephone-delivered diabetes education and skills training intervention is an effective strategy to improve metabolic control in AA patients with T2DM.

This study provides a unique opportunity to address gaps in the literature by testing the efficacy of a technology-intensified diabetes education/skills training (TIDES) intervention in AAs with poorly controlled T2DM. The long-term goal of the project is to identify effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in AAs with T2DM.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥21 years
  • Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
  • Self-identified as AA
  • Subject must be willing to use the FORA monitoring system for 12 months
  • Subjects must be able to communicate in English
  • Subjects must have access to a telephone (landline for data uploads) for the study period

Exclusion Criteria:

  • Mental confusion on interview suggesting significant dementia
  • Participation in other diabetes clinical trials
  • Alcohol or drug abuse/dependency
  • Active psychosis or acute mental disorder
  • Life expectancy <12 months
  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: NCT02088658

Contacts
Contact: Aprill Dawson, MPH 843-876-0295 dawson@musc.edu
Contact: Joni L Strom Williams, MD, MPH 843-792-0906 stromjl@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Aprill Dawson, MPH    843-876-0895    dawson@musc.edu   
Contact: Joni L Strom Williams, MD, MPH    843-792-0906    stromjl@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Leonard E Egede, MD, MS Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02088658     History of Changes
Other Study ID Numbers: Pro00015064, 1R01DK098529
Study First Received: March 13, 2014
Last Updated: March 13, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
Diabetes Mellitus, Non-Insulin-Dependent
Diabetes Mellitus, Noninsulin Dependent
Diabetes Mellitus, Type II
African Americans
Blacks
non-Hispanic Blacks
Randomized Control Trial
Controlled Clinical Trial
Behavioral Research
Behavioral Medicine

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

ClinicalTrials.gov processed this record on July 29, 2014