NCT00987285

Linking Self-Management and Primary Care for Diabetes 2

Linking Self-Management and Primary Care for Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 463 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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). Primary hypotheses: 1. 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. 2. That the ASM+ES condition will be superior to the ASM alone condition on primary outcomes at the 12-month follow-up.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	CASM +	Computer Assisted Self Management plus Social Support
BEHAVIORAL	CASM	Computer Assisted Self Management using and interactive, automated self-management program that uses web and interactive voice recognition (IVR) media

Timeline

• Start date: 2007-01-01
• Primary completion: 2011-12-01
• Completion: 2014-12-01
• First posted: 2009-09-30
• Last updated: 2015-05-25

Locations

1 site across 1 country: United States