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

April 24, 2015 updated by: John Piette, University of Michigan

Effective Care Management of Depressed Diabetes Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

339

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Enhanced Usual Care

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
Adult patients with diabetes and depression
Behavioral: Medication Care Management (MCM)
  • 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)
Behavioral: Cognitive-Behavioral Therapy (CBT)
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Participant HbA1c levels
Time Frame: one year
one year
Participant cardiovascular risk index
Time Frame: one year
one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
US Department of Veterans Affairs
Genesys Health System

Investigators

  • Principal Investigator: John D Piette, PhD, VA Ann Arbor Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

April 15, 2010

First Submitted That Met QC Criteria

April 16, 2010

First Posted (Estimate)

April 20, 2010

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 24, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R18DK066166-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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