Effective Care Management of Depressed Diabetes Patients (The Positive Steps Study)

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

Detailed Description
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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.

Official Title
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Effective Care Management of Depressed Diabetes Patients

Conditions
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Diabetes, Depression

Intervention / Treatment
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* Behavioral: Medication Care Management (MCM)
* Behavioral: Cognitive-Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria. Patients must meet all of the following criteria: Active Diabetes (Type 1 & 2) Diagnosis of depression Using hypoglycemic medications At least 1 outpatient visit in last 12 months At least 21 years old Exclusion Criteria. Patients who have any of the following will be excluded: Limited life expectancy (heart failure/ on oxygen/ advanced stage cancer/ dialysis) End stage renal disease Lung cancer Dementia Bipolar Schizophrenia Can't speak English Memory problems Alcohol problems Illegal drug use Minimal depressive symptoms Blood pressure 180/110 or higher Problems with loss of consciousness Can't walk 10 minutes on level surface Not planning to get their care at study site PCP not affiliated with study site Are not on a stable regimen (change in depression Rx in last 28-30 days) Type 1 diabetic if diagnosed before age 15

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Enhanced Usual Care<br>Adult patients with diabetes and depression. Report screening results Notify PCP of screening results (optional per patient) PCP referrals Educational materials regarding diabetes, physical activity, and depression | |
| Experimental: Staged Care Management<br>Adult patients with diabetes and depression | Behavioral: Medication Care Management (MCM)<br>* 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)<br>Behavioral: Cognitive-Behavioral Therapy (CBT)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant HbA1c levels |  | one year | 
| Participant cardiovascular risk index |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proximal intervention targets | (e.g., depressive symptoms, physical activity levels, and provider-patient communication) | one year | 
| Other self-care behaviors |  | one year | 
| Health-related quality of life |  | one year | 
| Treatment satisfaction |  | one year | 
| Resource use |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Depression, Telephone Care Management, Medication Care Management (MCM), Cognitive Behavioral Therapy (CBT)