The Diabetes TeleCare Study (DTC)
|ClinicalTrials.gov Identifier: NCT00288132|
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Intervention Behavioral: Usual Care||Not Applicable|
According to recent 2002 estimates, the yearly cost of diabetes was approximately $132 billion. The burden of diabetes is considerable, particularly for ethnically diverse populations. Disease management programs that focus on self-management education have been effective in improving metabolic control. Accordingly, the American Diabetes Association clinical care guidelines stress the importance of metabolic control to prevent complications and improve quality of life for persons with this disease. Unfortunately, these advances have not resulted in widespread acceptance into clinical practice. Therefore, we propose translational research to evaluate telemedicine technology using interactive video conferencing (Diabetes TeleCare) as a novel means to increase the availability of health professionals in rural communities for the effective delivery of a diabetes self-management education program and as a means to provide retinal screenings in the primary care setting. Our aims are to 1) develop and implement a 12-month intervention, Diabetes TeleCare to improve adherence to diabetes clinical care guidelines and improve diabetes control in two community health centers located in ethnically diverse, rural and medically underserved communities, 2) conduct a one-year randomized clinical trial (RCT) of 200 patients to formally evaluate the effectiveness of Diabetes TeleCare compared to Usual Care in a sample with >60% African-Americans, and 3) determine the cost-effectiveness and satisfaction of Diabetes TeleCare compared to Usual Care. Participants are recruited from two community health centers in rural South Carolina and randomized according to a patient randomization schedule. Diabetes TeleCare (a structured curriculum) is delivered by a team consisting of a registered nurse/certified diabetes educator (RN-CDE) and an experienced registered dietitian, with support by other health professionals who are linked by interactive video conferencing to participants (single and group) in rural health centers at distant locations. The primary outcomes are measures of metabolic control (A1c, lipids), blood pressure, and use of the telemedicine-facilitated retinal screening capacity. Secondary outcomes include satisfaction, quality of life, health beliefs, and knowledge. The economic analysis will include an assessment of resource utilization, cost, and health utilities. In addition, incremental reductions in costs per A1c and the estimated lifetime cost-utility of Diabetes TeleCare compared to usual care will be determined. Telemedicine may be an effective alternative to traditional health care delivery systems resulting in improved diabetes education and control.
The intervention goal was to achieve an A1c <7%, with secondary goals of 10% weight loss and increasing exercise to at least 30 minutes a day, 5 days a week. Participants attend 13 sessions, 2 in the first month (1 group, 1 individual), monthly thereafter (9 group, 2 individual). Three group sessions were conducted in-person, all others were conducted via telemedicine. The self-management education team consisted of an RN/CDE and an RD. Sessions were conducted remotely, with a trained facilitator (LPN) at the clinic site. Participants were given a notebook and new material was added at each session. Completion of self-monitoring logs, including blood sugar, diet and physical activity, was assigned daily followed by less frequently based on progress towards intervention goals.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bridging Barriers to Diabetes Care With Telemedicine: The Diabetes TeleCare Study (DTC)|
|Actual Study Start Date :||September 2005|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
|Active Comparator: Usual Care||
Behavioral: Usual Care
Upon randomization, received one 15-minute diabetes self-management individual session, using American Diabetes Association materials. Continued care, as usual, from their primary care provider throughout duration of active 12 month intervention period.
A 12-month diabetes self-management intervention delivered via telemedicine, with opportunity to receive telemedicine-based screening eye exam, was conducted.
- Hemoglobin A1c [ Time Frame: 6 mths, 12 mths, 24 mths ]
- Blood pressure [ Time Frame: 6 mths, 12 mths, 24 mths ]
- LDL Cholesterol [ Time Frame: 6 mths, 12 mths, 24 mths ]
- Cost effectiveness and cost utility [ Time Frame: 6 mths, 12 mths ]
- Retinal examination rates [ Time Frame: 12 months ]
- Weight [ Time Frame: 6 mths, 12 mths, 24 mths ]
- Waist Circumference [ Time Frame: 6 mths, 12 mths, 24 mths ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288132
|United States, South Carolina|
|Bennettsville, South Carolina, United States, 29512|
|Principal Investigator:||Richard M Davis, MD||University of South Carolina|