Linking Self-Management and Primary Care for Diabetes 2 (LB2)
|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: NCT00987285|
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : May 25, 2015
This project is primarily a behavioral study. We employed a three-arm, patient-randomized practical effectiveness trial to evaluate the impact of two different interactive, multimedia self-management programs, relative to "enhanced" usual care. The two interventions will be (a) the revised program from our present study, based on our social-ecological theory and the 5 As self-management model, plus enhanced support (ASM+ES) that includes practical, but extensive, ongoing support and b) largely Automated Self-Management (ASM). These programs will be compared to a realistic "enhanced usual care" (UC) condition that will provide health risk appraisal feedback, control for computer interactions, and provide standardized advice on behavior change, but not the hypothesized key intervention processes of goal-setting, barriers identification, problem-solving, or social-environmental support. Patients will be randomized to conditions within clinic and will participate for 1 year.
The proposed project will test the effectiveness of a practical, automated-based intervention for primary care patients to facilitate dietary and physical activity practices, and medication-taking. Analyses will focus on primary outcomes of (a) dietary, physical activity, medication-taking outcomes, and (b) the UKPDS risk equation as well as secondary quality-of-life, patient-activation, and patient care outcomes (Specific Aim #2). Using the RE-AIM measures, we will analyze the reach, effectiveness, adoption, implementation, and maintenance of the intervention programs (Specific Aim #3), and also factors related to program implementation, linkage to primary care, and program success with emphasis on cost, cost-effectiveness, and mediators and moderators of outcomes such as social-environment support (Aim #4).
- That the Automated Intervention received by Automated self-management (ASM) condition and ASM plus enhanced support conditions (ASM+ES) will be superior to usual care on the primary outcomes.
- That the ASM+ES condition will be superior to the ASM alone condition on primary outcomes at the 12-month follow-up.
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes Mellitus||Behavioral: CASM + Behavioral: CASM|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||463 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Linking Self-Management and Primary Care for Diabetes|
|Study Start Date :||January 2007|
|Primary Completion Date :||December 2011|
|Study Completion Date :||December 2014|
Experimental: Computer Assisted Self Management plus Social Support
an interactive, automated self-management (ASM) program that uses web and interactive voice recognition (IVR) media combined with enhanced support in the form of group Diabetes Care Management visits and live follow up phone calls from Diabetes Care Managers
Behavioral: CASM +
Computer Assisted Self Management plus Social Support
No Intervention: Usual care
will receive a health-risk appraisal, interactive CD-ROM program that provides standardized advice on behavior change, but not the hypothesized key intervention processes of goal setting, barriers identification, problem solving, or social environmental support.
Experimental: Computer Assisted Self Management
An interactive, automated self-management (ASM) program that uses web and interactive voice recognition (IVR) media.
Computer Assisted Self Management using and interactive, automated self-management program that uses web and interactive voice recognition (IVR) media
- Improvement in health behaviors (e.g., dietary patterns, physical activity, medication taking) and biologic outcomes (HbA1c, lipid ratio, blood pressure, and smoking status). [ Time Frame: Baseline, 4 months and 12 months ]
- Diabetes-specific quality of life (Diabetes Distress Scale), patient activation (PAM scale), and perceived social-environmental support (the Chronic Illness Resources Survey) at 4- and 12-month follow-ups. [ Time Frame: 4 and 12 months ]
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): NCT00987285
|United States, Colorado|
|Kaiser Permanente of Colorado|
|Denver, Colorado, United States, 80237-8066|
|Principal Investigator:||Russell E Glasgow, PhD||Kaiser Permanente|