Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00468676

Purpose

This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.

Condition	Intervention
Depression	Behavioral: Nurse-led case management Behavioral: Treatment as usual

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Trial of Liaison Psychiatry in Primary Care

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Depression Heart Diseases

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

combined effect of intervention on SCL-20, sytolic blood pressure, LDL and HbA1c [ Time Frame: Measured at Months 6, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Functional impairment [ Time Frame: Measured at Months 6, 12 months ] [ Designated as safety issue: No ]
Combined effect of intervention on sytolic blood pressure, HbA1c and LDL [ Time Frame: Measured at Months 6, 12 months ] [ Designated as safety issue: No ]
Health care costs [ Time Frame: Measured at Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	May 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: B Treatment as usual	Behavioral: Treatment as usual Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care.
Experimental: A Case management intervention	Behavioral: Nurse-led case management The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress.

Arms

Assigned Interventions

Active Comparator: B

Treatment as usual

Behavioral: Treatment as usual

Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care.

Experimental: A

Case management intervention

Behavioral: Nurse-led case management

The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress.

Detailed Description:

Depression is a serious medical illness that has been associated with increased risk for heart disease and diabetes. Depression may negatively impact aspects of self-care that are required to effectively manage such long-term diseases. In depressed people who have heart disease and/or diabetes, treatment for depression appears to result in only limited improvements in depression symptoms and no improvements in heart disease and diabetes symptoms. An integrated treatment approach may be more effective in improving all three conditions. This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed.

Participants in this single-blind study will be randomly assigned to take part in the case management intervention or receive usual care. All participants will attend 5 in-person study evaluation visits and receive 4 follow-up phone calls over 24 months. At each of the study visits, measurements of height, weight, waist size, and blood pressure will be taken. At study evaluations, blood and urine samples will also be taken. Participants will be asked not to eat for 8 hours before providing blood samples at 3 of the visits. During follow-up phone calls participants will answer various questions.

The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress. Outcomes will be measured at Months 6, 12, 18, and 24 months.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of diabetes and/or heart disease
Poor disease control (defined as an HbA1c level of at least 8.5%, blood pressure greater than 140/90 mm Hg, LDL cholesterol greater than 130 mg/dL)
Diagnosis of major depressive disorder

Exclusion Criteria:

History of psychosis
At high risk for suicide
Cognitive impairment
Current alcohol or substance abuse disorder
Does not own a telephone
Currently seeking psychiatric care
Pregnant or breastfeeding
Currently enrolled in a Group Health Cooperative disease management program
Terminal illness
Plans to leave Group Health Cooperative in less than a year
Does not speak English

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468676

Locations

United States, Washington
Group Health Cooperative
Seattle, Washington, United States, 98101

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Wayne J. Katon, MD

University of Washington

More Information

Publications:

Katon WJ, Von Korff M, Lin EH, Simon G, Ludman E, Russo J, Ciechanowski P, Walker E, Bush T. The Pathways Study: a randomized trial of collaborative care in patients with diabetes and depression. Arch Gen Psychiatry. 2004 Oct;61(10):1042-9.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Von Korff M, Katon WJ, Lin EH, Ciechanowski P, Peterson D, Ludman EJ, Young B, Rutter CM. Functional outcomes of multi-condition collaborative care and successful ageing: results of randomised trial. BMJ. 2011 Nov 10;343:d6612.

Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20.

Responsible Party:	Wayne J. Katon, MD, Group Health Cooperative
ClinicalTrials.gov Identifier:	NCT00468676 History of Changes
Other Study ID Numbers:	R01 MH41739, DSIR 82-SEPC
Study First Received:	May 1, 2007
Last Updated:	August 30, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

MDD
Diabetes
Heart Disease

Additional relevant MeSH terms:

Cardiovascular Diseases
Depression
Depressive Disorder

Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 12, 2012