Linking Self-Management and Primary Care for Diabetes 2

Study Overview
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Brief Summary
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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: 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. That the ASM+ES condition will be superior to the ASM alone condition on primary outcomes at the 12-month follow-up.

Official Title
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Linking Self-Management and Primary Care for Diabetes

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: CASM +
* Behavioral: CASM


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer Assisted Self Management plus Social Support<br>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 | Behavioral: CASM +<br>* Computer Assisted Self Management plus Social Support<br>|
| No Intervention: Usual care<br>will receive a health-risk appraisal, interactive CD-ROM program that provides standardized advice on behavior change, but not the hypothesized key intervention processes of goal setting, barriers identification, problem solving, or social environmental support. | |
| Experimental: Computer Assisted Self Management<br>An interactive, automated self-management (ASM) program that uses web and interactive voice recognition (IVR) media. | Behavioral: CASM<br>* Computer Assisted Self Management using and interactive, automated self-management program that uses web and interactive voice recognition (IVR) media<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RE AIM model, Type 2 Diabetes Mellitus, Interactive voice recognition, Computer Assisted Self Management