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

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), April 2008

Sponsored by: 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

MedlinePlus related topics:   Depression    Diabetes    Heart Diseases   

ChemIDplus related topics:   Attapulgite    Bismuth subsalicylate    Kaopectate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:   Randomized Trial of Liaison Psychiatry in Primary Care

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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Arms Assigned Interventions
B: Active Comparator
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.
A: Experimental
Case management intervention
Behavioral: Nurse-led case management
Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. The case management intervention will entail 2 to 8 additional 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 10 study visits and receive 4 follow-up phone calls over 24 months. At 5 of the study visits, measurements of height, weight, waist size, and blood pressure will be taken. At the other 5 study visits, blood and urine samples will 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 two to eight additional 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.

  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

Contacts
Contact: Wayne J. Katon, MD     206-543-7177     wkaton@u.washington.edu    
Contact: Michael Von Korff, ScD     206-287-2874     vonkorff.m@ghc.org    

Locations
United States, Washington
Group Health Cooperative     Recruiting
      Seattle, Washington, United States, 98101
      Contact: Wayne J Katon, MD     206-543-7177     wkaton@u.washington.edu    
      Contact: Michael Von Korff, ScD     206-287-2874     vonkorff.m@ghc.org    
      Principal Investigator: Michael Von Korff, ScD            

Sponsors and Collaborators

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

Publications:

Responsible Party:   Group Health Cooperative ( Wayne J. Katon, MD )
Study ID Numbers:   R01 MH41739, DSIR 82-SEPC
First Received:   May 1, 2007
Last Updated:   April 1, 2008
ClinicalTrials.gov Identifier:   NCT00468676
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
MDD  
Diabetes  
Heart Disease  

Study placed in the following topic categories:
Attapulgite
Depression
Heart Diseases
Mental Disorders
Mood Disorders
Diabetes Mellitus
Depressive Disorder
Bismuth subsalicylate
Behavioral Symptoms

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 18, 2008




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