Clinical trial NCT01106885: Effective Care Management of Depressed Diabetes Patients (The Positive Steps Study)
Official title: Effective Care Management of Depressed Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Depression
Keywords: Diabetes
Depression
Telephone Care Management
Medication Care Management (MCM)
Cognitive Behavioral Therapy (CBT)
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
name: Genesys Health System
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-04-20
Enrollment: 339
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Participant HbA1c levels
timeFrame: one year
measure: Participant cardiovascular risk index
timeFrame: one year
Secondary outcomes:
measure: Proximal intervention targets
timeFrame: one year
measure: Other self-care behaviors
timeFrame: one year
measure: Health-related quality of life
timeFrame: one year
measure: Treatment satisfaction
timeFrame: one year
measure: Resource use
timeFrame: one year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System
name: John D Piette, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piette JD, Valenstein M, Himle J, Duffy S, Torres T, Vogel M, Richardson C. Clinical complexity and the effectiveness of an intervention for depressed diabetes patients. Chronic Illn. 2011 Dec;7(4):267-78. doi: 10.1177/1742395311409259. Epub 2011 Aug 12.