Type 2 Diabetes Mellitus Clinical Trial
Official title:
Linking Self-Management and Primary Care for Diabetes
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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