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

Depression Clinical Trial

Official title:

Effective Care Management of Depressed Diabetes Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106885
• Other study ID #: 1R18DK066166-01A1
• Secondary ID: 1R18DK066166-01A
• Status: Completed
• Phase: N/A
• First received: April 15, 2010
• Last updated: April 24, 2015
• Start date: May 2005
• Est. completion date: April 2011

Study information

• Verified date: April 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: April 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Diabetes

Intervention

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)
• 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

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan
United States	Genesys Regional Medical Center	Grand Blanc	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	Genesys Health System, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant HbA1c levels		one year	No
Primary	Participant cardiovascular risk index		one year	No
Secondary	Proximal intervention targets	(e.g., depressive symptoms, physical activity levels, and provider-patient communication)	one year	No
Secondary	Other self-care behaviors		one year	No
Secondary	Health-related quality of life		one year	No
Secondary	Treatment satisfaction		one year	No
Secondary	Resource use		one year	No