Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00288132
Status:
COMPLETED
Last Update Posted:
2018-03-02
First Post:
2006-02-06
Brief Title:
The Diabetes TeleCare Study
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Bridging Barriers to Diabetes Care With Telemedicine The Diabetes TeleCare Study DTC
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DTC
Brief Summary:
The American Diabetes Association clinical care guidelines stress the importance of metabolic control to prevent complications and improve quality of life for persons with diabetes Unfortunately these guidelines have not had 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
Detailed Description:
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 nursecertified 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 RNCDE 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
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 RNCDE 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R18DK067312 | NIH | None | httpsreporternihgovquickSearchR18DK067312 |