Type 2 Diabetes Mellitus
Conditions
Keywords
RE AIM model, Type 2 Diabetes Mellitus, Interactive voice recognition, Computer Assisted Self Management
Brief 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.
Interventions
BEHAVIORALCASM +
Computer Assisted Self Management plus Social Support
BEHAVIORALCASM
Computer Assisted Self Management using and interactive, automated self-management program that uses web and interactive voice recognition (IVR) media
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
InterVision
Oregon Research Institute
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria: * being 25-75 years of age, * live independently, * have a telephone, * are able to read in either English or Spanish, * able to access the Internet at least twice per week * are capable of providing informed consent, * have been diagnosed with type 2 diabetes for at least 1 year * are overweight (BMI ≥ 25), and * have at least one additional UKPDS equation risk factor (i.e., high lipids, hypertension, HbA1c, or smoking)
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in health behaviors (e.g., dietary patterns, physical activity, medication taking) and biologic outcomes (HbA1c, lipid ratio, blood pressure, and smoking status). | Baseline, 4 months and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 4 and 12 months |
Countries
United States
Outcome results
None listed