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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01106885
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : April 28, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Diabetes Depression Behavioral: Medication Care Management (MCM) Behavioral: Cognitive-Behavioral Therapy (CBT)

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effective Care Management of Depressed Diabetes Patients
Study Start Date : May 2005
Primary Completion Date : October 2009
Study Completion Date : April 2011
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Participant HbA1c levels [ Time Frame: one year ]
  2. Participant cardiovascular risk index [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Proximal intervention targets [ Time Frame: one year ]
    (e.g., depressive symptoms, physical activity levels, and provider-patient communication)

  2. Other self-care behaviors [ Time Frame: one year ]
  3. Health-related quality of life [ Time Frame: one year ]
  4. Treatment satisfaction [ Time Frame: one year ]
  5. Resource use [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106885


Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
University of Michigan
VA Office of Research and Development
Genesys Health System
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: John D Piette, PhD VA Ann Arbor Healthcare System
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Piette, VA Senior Research Career Scientist and Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT01106885     History of Changes
Other Study ID Numbers: 1R18DK066166-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015

Keywords provided by John Piette, University of Michigan:
Diabetes
Depression
Telephone Care Management
Medication Care Management (MCM)
Cognitive Behavioral Therapy (CBT)

Additional relevant MeSH terms:
Diabetes Mellitus
Depression
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms