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Table 2 Data Collection Measures and Instruments

From: Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): study protocol for a randomized controlled trial

Measure Data Collected Method
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.