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Clinical Trials/NCT01106885
NCT01106885
Completed
Not Applicable

Effective Care Management of Depressed Diabetes Patients

University of Michigan3 sites in 1 country339 target enrollmentMay 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
University of Michigan
Enrollment
339
Locations
3
Primary Endpoint
Participant HbA1c levels
Status
Completed
Last Updated
11 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 2005
End Date
April 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John Piette

VA Senior Research Career Scientist and Professor of Internal Medicine

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Participant HbA1c levels

Time Frame: one year

Participant cardiovascular risk index

Time Frame: one year

Secondary Outcomes

  • Proximal intervention targets(one year)
  • Other self-care behaviors(one year)
  • Health-related quality of life(one year)
  • Treatment satisfaction(one year)
  • Resource use(one year)

Study Sites (3)

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