Proactive Diabetes Case Management
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00013208|
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Behavioral: Case Management||Not Applicable|
Despite a growing array of therapeutic options and efficacious treatment strategies to prevent or delay some of the most severe complications of type 2 diabetes, there continue to be many individuals with outcomes that are far from optimal. Interventions to improve diabetes care by educating providers and patients have been disappointing. In the past several years, case management has been widely advocated as a cost-effective approach to coordinate diabetes care and improve outcomes, although there is little rigorous evidence demonstrating the benefits of this type of intervention.
This study had the following specific aims: 1) to evaluate the effect of a targeted, proactive case management intervention for high risk veterans with type 2 diabetes on: a) glycemic control, b) intermediate cardiovascular outcomes, c) satisfaction, d) adherence to specific care standards, and e) short-term resource utilization; and 2) using Monte Carlo simulation models, to estimate the expected impact of changes in key processes of care and intermediate outcomes on end-stage outcomes.
This study was conducted as a prospective randomized controlled trial. Participating veterans with diabetes (N = 246) receiving care at two VAMCs were randomly assigned, stratified by site and baseline hemoglobin A1c (A1c), to the intervention or control group. The intervention consisted of two nurse practitioners who actively monitored and coordinated patient care, guided by approved treatment algorithms. Data for the study were collected through a baseline and exit examination, a baseline and exit survey, and the VA medical information system. The primary outcome measure was the change in glycemic control, as measured by A1c. Secondary outcomes included serum LDL, blood pressure, satisfaction, and resource utilization. The data were analyzed using univariate and bi-variate (t-test, Wilcoxon rank-sum, chi-square) methods as well as multivariable regression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Proactive Diabetes Case Management|
|Actual Study Completion Date :||August 2002|
Behavioral: Case Management
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00013208
|United States, Michigan|
|VA Ann Arbor Healthcare System, Ann Arbor, MI|
|Ann Arbor, Michigan, United States, 48105|
|Principal Investigator:||Sarah L. Krein, PhD RN||VA Ann Arbor Healthcare System, Ann Arbor, MI|
|Principal Investigator:||Alan J. Pawlow, MD||John D. Dingell VA Medical Center, Detroit, MI|
|Principal Investigator:||Rodney A. Hayward, MD||VA Ann Arbor Healthcare System, Ann Arbor, MI|