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

Not Applicable

Completed

• Conditions: Diabetes; Depression
• Interventions: Behavioral: Medication Care Management (MCM); Behavioral: Cognitive-Behavioral Therapy (CBT)

• Registration Number: NCT01106885
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2009-10
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-16
• Study First Posted: 2010-04-20
• Study Completion: 2011-04
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-24
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 339

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Staged Care Management	Cognitive-Behavioral Therapy (CBT)	Adult patients with diabetes and depression
Staged Care Management	Medication Care Management (MCM)	Adult patients with diabetes and depression

Primary Outcome Measures

Name	Time	Method
Participant HbA1c levels	one year
Participant cardiovascular risk index	one year

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

VA Ann Arbor Healthcare System; 🇺🇸 Ann Arbor, Michigan, United States

Genesys Regional Medical Center; 🇺🇸 Grand Blanc, Michigan, United States