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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wayne Katon, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00468676
First received: May 1, 2007
Last updated: June 6, 2013
Last verified: June 2013
  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:


Further study details as provided by University of Washington:

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 ]

Enrollment: 214
Study Start Date: May 2007
Study Completion Date: August 2012
Primary Completion Date: October 2010 (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.

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
University of Washington
Investigators
Principal Investigator: Wayne J. Katon, MD University of Washington
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wayne Katon, Professor, Vice Chair University of Washington, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00468676     History of Changes
Other Study ID Numbers: R01 MH41739, R01MH041739, DSIR 82-SEPC
Study First Received: May 1, 2007
Last Updated: June 6, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
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 April 17, 2014