Linking Self-Management and Primary Care for Diabetes 2
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Behavioral: CASMBehavioral: CASM +
- Registration Number
- NCT00987285
- Lead Sponsor
- Kaiser Permanente
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 463
- 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:
- Suffering dementia or active psychosis,
- Being on end-stage dialysis,
- or predicted to live fewer than 2 years
- Being institutionalized.
- Pregnant women - women with gestational diabetes will not be enrolled, because there needs are quite different, but we won't specifically exclude women who are pregnant AND otherwise eligible, since we do acknowledge that it's possible that someone may be unaware that they are pregnant at the time of enrollment, or may become pregnant during the study, and that this will not affect their continued participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Computer Assisted Self Management CASM An interactive, automated self-management (ASM) program that uses web and interactive voice recognition (IVR) media. Computer Assisted Self Management plus Social Support CASM + 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Kaiser Permanente of Colorado
🇺🇸Denver, Colorado, United States