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Disease Management and Educational Intervention Outcomes in High-Risk Diabetics Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Disease Management and Educational Intervention Outcomes in High-Risk Diabetics conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Disease Management and Educational Intervention Outcomes in High-Risk Diabetics Clinical research trials and Disease Management and Educational Intervention Outcomes in High-Risk Diabetics healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Disease Management and Educational Intervention Outcomes in High-Risk Diabetics. Disease Management and Educational Intervention Outcomes in High-Risk Diabetics Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Disease Management and Educational Intervention Outcomes in High-Risk Diabetics clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Disease Management and Educational Intervention Outcomes in High-Risk Diabetics condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Disease Management and Educational Intervention Outcomes in High-Risk Diabetics  Disease Management and Educational Intervention Outcomes in High-Risk Diabetics
Disease Management and Educational Intervention Outcomes in High-Risk Diabetics
For Condition: Diabetes Mellitus, Non-Insulin-Dependent
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Health Services Research and Development Service,Department of Veterans Affairs - Veterans Integrated Services Network
Synopsis: The principal social, medical and economic burdens of diabetes care in the VHA result from microvascular, macrovascular and neurological complications. Sustained reduction in hyperglycemia can reduce the incidence of these complications by as much as 50 percent. Studies have demonstrated improved glycemic control outcomes with nurse case-management or educational care models. However, none have: (1) controlled for the independent contributions; (2) intervened with advanced practice nurses (APN); or (3) targeted for highest risk individuals. The immediate objective of this proposed effectiveness research is to implement and evaluate a risk-stratified, disease-specific case-managed diabetes self-management education program. The project will: (1) identify patients at highest risk for sustaining adverse health outcomes; (2) provide patients with timely access to educational and therapeutic interventions appropriate to their clinical state; (3) monitor specific behavioral goals, diabetes guideline-based process measures and health outcomes; and (4) provide primary care providers with clearly defined sub-specialty services. This guidelines-consistent model combines a focused, behaviorally-oriented Diabetes Self-Management Education Program with Diabetes-Specific Case-management by an Advanced Practice Nurse (APN). The long-term objective is to produce reliable and valid data to examine whether interventions of diabetes self-management education programs and the utilization of APN case managers are cost effective, while improving patient and system outcomes. The objectives of this study are to be met through a randomized, factorial design. Patients (n=1800) are randomly assigned to one of four groups: (1) Disease-management and diabetes education; (2) Disease-management alone; (3) Diabetes education alone; and (4) Routine Care. Consistent with the VHA Diabetes Risk-Stratification Model (Diabetes Clinical Practice Guidelines), patients at highest risk for complications (HbA1c > 9.5%) will be targeted. Patients are identified from VISTA lab searches of HbA1c results. Veterans (all races, both genders) receiving primary care in VISN 5 and meeting high-risk criteria are included. Patient outcome measures will be collected at baseline, three months and 12 months and include: Quality of Life scores (SF-36V and diabetes-specific QOL), HbA1c levels, compliance with annual retinal and foot exams, and secondarily the incidence of diabetes-related hospitalizations/ER visits. ANCOVA comparisons between group means on changes from baseline to one year will be utilized. Secondarily, patient-level intervention costs, health care use and costs will be examined. An incremental cost-effectiveness analysis from the VHA's perspective will compare each intervention against routine care. Data will be VHA utilization from VISTA-CPRS, self-report QOL score's and non-VHA use.
Details:
Eligibility:
Study Type: Interventional, Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients must have a recent HbA1c>_9.5
Total Enrollment: 1800
Location and Contact Information:
VA Maryland Health Care System
Baltimore, Maryland, 21201
United States
VA Maryland Health Care System
Baltimore, Maryland, 21201
United States
Additional Information:
Study ID Numbers: DII 99-188;
Study Start Date: January 2000
Record last reviewed: October 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012662
Other Diabetes Mellitus, Non-Insulin-Dependent Studies:
1. Obese Patients with Type 2 Diabetes
2. Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination
3. A Research Study to Assess the Mechanism By Which Glucovance, Metformin, and Glyburide Work To Control Glucose Levels In Patients With Type 2 Diabetes
4. Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With a Sulfonylurea
5. An evaluation of an oral antidiabetic agent for the treatment of type 2 diabetes
Related Studies:
Other Diabetes Mellitus, Non-Insulin-Dependent Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Disease Management and Educational Intervention Outcomes in High-Risk Diabetics
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