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| ID | Type | Description | Link |
|---|---|---|---|
| 1R18DK066166-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
| Genesys Health System | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Evaluation of telephone care management intervention designed to improve outcomes among depressed diabetes patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care | No Intervention | Adult patients with diabetes and depression.
| |
| Staged Care Management | Experimental | Adult patients with diabetes and depression |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication Care Management (MCM) | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant HbA1c levels | one year | |
| Participant cardiovascular risk index | one year |
| 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 |
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Inclusion Criteria. Patients must meet all of the following criteria:
Exclusion Criteria. Patients who have any of the following will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| John D Piette, PhD | VA Ann Arbor Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | 48105 | United States | ||
| University of Michigan Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21840915 | Derived | Piette JD, Valenstein M, Himle J, Duffy S, Torres T, Vogel M, Richardson C. Clinical complexity and the effectiveness of an intervention for depressed diabetes patients. Chronic Illn. 2011 Dec;7(4):267-78. doi: 10.1177/1742395311409259. Epub 2011 Aug 12. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003863 | Depression |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Cognitive-Behavioral Therapy (CBT) | Behavioral |
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| Health-related quality of life | one year |
| Treatment satisfaction | one year |
| Resource use | one year |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |