Linking Self-Management and Primary Care for Diabetes 2

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

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• InterVision

  collaborator UNKNOWN

• Oregon Research Institute

  collaborator OTHER

• Kaiser Permanente

  lead OTHER

Principal Investigators

• Russell E Glasgow, PhD · Kaiser Permanente

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2011-12-31

Completion

2014-12-31

Countries

• United States

Study Locations