Effective Care Management of Depressed Diabetes Patients (The Positive Steps Study)
Condition: Diabetes; Depression
MeSH terms: Diabetes Mellitus; Depression
Study type: Interventional

Summary: 
      Evaluation of telephone care management intervention designed to improve outcomes among
      depressed diabetes patients.
    

Detailed description: 
      Research Plan: 382 patients ages 21-80, including 177 women, and 123 Blacks from the Ann
      Arbor VA HCS, UM, and the Genesys Health Care System in Flint. Patients will be randomized
      to: (1) brief education about depression, diabetes self-care, and physical activity; or (2)
      telephone care management including antidepressant medication care management (MCM) and/or
      cognitive behavioral therapy (CBT). The MCM module uses a standard algorithm to identify
      efficacious antidepressants and promote adherence. The CBT module addresses symptoms,
      exercise, and communication skills.

      Methods: Surveys: Patients will complete clinic-based surveys at baseline and 12-months to
      measure their health status, self-care, provider-patient communication, and resource use. At
      4 months, they will complete a mailed questionnaire to capture short-term changes in
      depressive symptoms, walking, patient-provider communication, medication adherence, and
      quality-of-life. Physiologic Measures: At baseline and 12-months, patients' A1c and
      cholesterol will be measured via a fingerstick blood test. We also will measure blood
      pressure, height, and weight. With patients' 4-month mailed surveys, they will complete
      fingerstick A1c tests and return the results via mail. The blood tests are identical to those
      diabetes patients use to self-monitor their blood glucose. Pedometers: We will measure
      distance walked at baseline, 4 months, and 12 months using a pedometer. Patients will record
      their walk distances for one week and return the results via mail. Electronic data:
      Utilization and billing databases will be used to identify health service utilization (ER
      visits, outpatient care, hospitalizations) occurring during patients' participation and the
      prior 12 months. Physician feedback. At patients' 12-month assessment, the physician will
      complete a brief survey about the patient's communication style. All patients will provide
      written consent administered prior to their face-to-face screening and baseline interviews.
      Physician 12-month surveys about patients' communication style will be anonymous.
    

Intervention name(s): Medication Care Management (MCM); Cognitive-Behavioral Therapy (CBT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Basic physical activity counseling
Notify PCP and facilitate initiation of antidepressants
Medication monitoring calls at 1, 2, 4, 6, 8, 10, and 12 weeks*
1/mo monitoring in continuation phase (mos. 4-12)*
Report & recommendations to PCP after each patient call
Note: *average of 10 minutes of telephone time each (series is repeated if second antidepressant trial is needed); Notify PCP
CBT Manual
Weekly CBT focused counseling for 12 weeks**
Monthly CBT in months 4-12**
Behavioral physical activity counseling
Report & recommendations to PCP after each patient call
Note: **average of 50 minutes of telephone time each
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes; Depression; Telephone Care Management; Medication Care Management (MCM); Cognitive Behavioral Therapy (CBT)