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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

339 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2011-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diabetes Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

Staged Care Management

Adult patients with diabetes and depression

Group Type EXPERIMENTAL

Medication Care Management (MCM)

Intervention Type BEHAVIORAL

* 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)

Cognitive-Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

* 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

Interventions

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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)

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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

* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No