Effective Care Management of Depressed Diabetes Patients (The Positive Steps Study)
Recruitment status was Active, not recruiting
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Purpose
Evaluation of telephone care management intervention designed to improve outcomes among depressed diabetes patients.
| Condition | Intervention |
|---|---|
|
Diabetes Depression |
Behavioral: Enhanced Usual Care Behavioral: Medication Care Management (MCM) Behavioral: Cognitive-Behavioral Therapy (CBT) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effective Care Management of Depressed Diabetes Patients |
- Participant HbA1c levels [ Time Frame: one year ] [ Designated as safety issue: No ]
- Participant cardiovascular risk index [ Time Frame: one year ] [ Designated as safety issue: No ]
- Proximal intervention targets [ Time Frame: one year ] [ Designated as safety issue: No ](e.g., depressive symptoms, physical activity levels, and provider-patient communication)
- Other self-care behaviors [ Time Frame: one year ] [ Designated as safety issue: No ]
- Health-related quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
- Treatment satisfaction [ Time Frame: one year ] [ Designated as safety issue: No ]
- Resource use [ Time Frame: one year ] [ Designated as safety issue: No ]
| Enrollment: | 339 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | April 2011 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Enhanced Usual Care
Adult patients with diabetes and depression
|
Behavioral: Enhanced Usual Care
|
|
Experimental: Staged Care Management
Adult patients with diabetes and depression
|
Behavioral: Medication Care Management (MCM)
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| Principal Investigator: | John D Piette, PhD | VA Ann Arbor Healthcare System |
More Information
No publications provided by University of Michigan Health System
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | John Piette, PhD, VA Ann Arbor Healthcare System |
| ClinicalTrials.gov Identifier: | NCT01106885 History of Changes |
| Other Study ID Numbers: | 1R18DK066166-01A1, 1R18DK066166-01A1 |
| Study First Received: | April 15, 2010 |
| Last Updated: | April 16, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan Health System:
|
Diabetes Depression Telephone Care Management Medication Care Management (MCM) Cognitive Behavioral Therapy (CBT) |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Diabetes Mellitus Behavioral Symptoms Mood Disorders |
Mental Disorders Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013