Table 2 Data Collection Measures and Instruments

Primary Outcome

Hemoglobin A1c

Blood specimens will be obtained at baseline, 3-, and 6-months visits.

Secondary Outcomes

Blood Pressure

Blood pressure readings will be obtained at baseline, 3-, and 6-months visits.

Quality of life

Quality of life will be measured by the SF-12 [31], which is a valid and reliable instrument to measure functional status.

Process Measures

Information

This will be measured by the 24-item Diabetes Knowledge Questionnaire (DKQ) [32]

Motivation

This will be measured with the 12-item Diabetes Fatalism Scales (DFS) [33].

Self-Efficacy

This will be measured by the perceived diabetes self-management scale (PDSMS) [34].

Behavioral Skills

This will be assessed with the Summary of Diabetes Self-Care Activities (SDSCA) scale [35].

Medication Adherence

This will be measured with the new 8-item self-report Morisky Medication Adherence Scale (MMAS) [36].

Self-report measures

Demographics

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.

Social support

The Medical Outcomes Study (MOS) Social Support Survey [38] will be used to measure social support.

Health Literacy

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.

Depression

The PHQ-9 is a brief questionnaire that scores each of the 9 DSM-IV criteria for depression [40].

Medical Comorbidity

The patient's history of medical comorbidity will be documented using a standardized and validated questionnaire [41].

Service Delivery Perceptions

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.

Treatment Credibility

To assess for differences in outcome expectancy, a modified treatment credibility scale developed by Borkovec and Nau (1972) will be used [42].

Resource Utilization & Cost

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.