Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109720
Status:
COMPLETED
Last Update Posted:
2010-01-15
First Post:
2005-05-02
Brief Title:
Evaluation of Diabetes Self-Management Consultant Care
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:
Evaluation of Diabetes Self-Management Consultant Care
Status:
COMPLETED
Status Verified Date:
2010-01
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:
None
Brief Summary:
The purpose of this study is to find out if Self-Management Consultant SMC intervention will be more effective than usual care in improving blood glucose control and diabetes-related quality of life for adults with type 2 diabetes
Detailed Description:
This study is designed to compare the effectiveness of a diabetes Self-Management Consultant SMC intervention for adults with type 2 diabetes with unsatisfactory glucose control ie HbA1c 8--the value chosen as high risk by the Diabetes Quality Improvement Project which is an initiative of the Health Care Financing Administration the American Diabetes Association and the Foundation for Accountability to a control group selected using the same criteria The SMC intervention will be implemented and evaluated in two different health care systems serving two distinct populations of patients with diabetes After signing the Informed Consent document subjects will be randomized to the SMC intervention or a control group All subjects in the study will complete a baseline assessment of their diabetes care and health status
Subjects randomized to the SMC intervention will have an individual meeting with the SMC to review and refine a self-management plan based on the subjects priorities and goals These subjects will receive individual follow-up and support during the year through monthly phone calls and an annual meeting with the SMC and their primary care physician Subjects randomized to the control group will receive usual care following their baseline and their 12- 24- and 36-month assessments Unlike most nurse-manager studies the SMCs interactions with patient care will use a theory-based behavioral approach with which we have extensive experience The study is designed to evaluate the effectiveness of the SMC intervention compared to usual care
All records will be handled confidentially Lab results and personal data will be linked by a research specific identifier code
Subjects randomized to the SMC intervention will have an individual meeting with the SMC to review and refine a self-management plan based on the subjects priorities and goals These subjects will receive individual follow-up and support during the year through monthly phone calls and an annual meeting with the SMC and their primary care physician Subjects randomized to the control group will receive usual care following their baseline and their 12- 24- and 36-month assessments Unlike most nurse-manager studies the SMCs interactions with patient care will use a theory-based behavioral approach with which we have extensive experience The study is designed to evaluate the effectiveness of the SMC intervention compared to usual care
All records will be handled confidentially Lab results and personal data will be linked by a research specific identifier code
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None