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Nurse-Led Case Management for Diabetes and Cardiovascular Disease Patients With Depression
This study is ongoing, but not recruiting participants.
Study NCT00468676   Information provided by National Institute of Mental Health (NIMH)
First Received: May 1, 2007   Last Updated: October 7, 2008   History of Changes

May 1, 2007
October 7, 2008
May 2007
September 2008   (final data collection date for primary outcome measure)
  • Score on the Symptom Checklist-20 (SCL-20) depression scale [ Time Frame: Measured at Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Percentage on disease control indices [ Time Frame: Measured at Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Score on the Symptom Checklist-20 (SCL-20) depression scale [ Time Frame: measured at Months 6, 12, 18, and 24 ]
  • Percentage on disease control indices [ Time Frame: measured at Months 6, 12, 18, and 24 ]
Complete list of historical versions of study NCT00468676 on ClinicalTrials.gov Archive Site
  • Functional impairment [ Time Frame: Measured at Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Adherence to prescribed medications [ Time Frame: Measured at Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Health care costs [ Time Frame: Measured at Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
  • Functional impairment [ Time Frame: measured at Months 6, 12, 18, and 24 ]
  • Adherence to prescribed medications [ Time Frame: measured at Months 6, 12, 18, and 24 ]
  • Health care costs [ Time Frame: measured at Months 6, 12, 18, and 24 ]
 
Nurse-Led Case Management for Diabetes and Cardiovascular Disease Patients With Depression
Randomized Trial of Liaison Psychiatry in Primary Care

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.

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.

 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Depression
  • Behavioral: Nurse-led case management
  • Behavioral: Treatment as usual
  • Active Comparator: Treatment as usual
  • Experimental: Case management intervention
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
300
September 2009
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00468676
Wayne J. Katon, MD, Group Health Cooperative
R01 MH41739, DSIR 82-SEPC
National Institute of Mental Health (NIMH)
 
Principal Investigator: Wayne J. Katon, MD University of Washington
National Institute of Mental Health (NIMH)
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP