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Primary Outcome
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Hemoglobin A1c
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Blood specimens will be obtained at baseline, 3-, and 6-months visits.
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Secondary Outcomes
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Blood Pressure
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Blood pressure readings will be obtained at baseline, 3-, and 6-months visits.
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Quality of life
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Quality of life will be measured by the SF-12 [31], which is a valid and reliable instrument to measure functional status.
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Process Measures
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Information
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This will be measured by the 24-item Diabetes Knowledge Questionnaire (DKQ) [32]
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Motivation
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This will be measured with the 12-item Diabetes Fatalism Scales (DFS) [33].
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Self-Efficacy
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This will be measured by the perceived diabetes self-management scale (PDSMS) [34].
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Behavioral Skills
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This will be assessed with the Summary of Diabetes Self-Care Activities (SDSCA) scale [35].
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Medication Adherence
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This will be measured with the new 8-item self-report Morisky Medication Adherence Scale (MMAS) [36].
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Self-report measures
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Demographics
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Previously validated items from the 2002 National Health Interview Survey [37] will be used to capture age, gender, race/ethnicity, marital status, household income, and health insurance.
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Social support
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The Medical Outcomes Study (MOS) Social Support Survey [38] will be used to measure social support.
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Health Literacy
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The abbreviated version of the Test of Functional Health Literacy in Adults (S-TOFHLA) [39] is designed to rapidly screen patients for potential health literacy problems.
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Depression
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The PHQ-9 is a brief questionnaire that scores each of the 9 DSM-IV criteria for depression [40].
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Medical Comorbidity
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The patient's history of medical comorbidity will be documented using a standardized and validated questionnaire [41].
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Service Delivery Perceptions
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This will be assessed with 5 items that have been previously validated in mental health studies. The items were slightly modified to be relevant to diabetes.
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Treatment Credibility
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To assess for differences in outcome expectancy, a modified treatment credibility scale developed by Borkovec and Nau (1972) will be used [42].
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Resource Utilization & Cost
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The perspective of cost will be that of the payer. Previously validated questions on resource utilization will be administered as a part of the baseline, 3-, and 6-month visits.
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