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: May 1, 2014
Last verified: May 2014
  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, Systolic Blood Pressure, LDL and HbA1c [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    A scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL: all data submitted as Outcome Measures #2-5 below) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.The model was estimated by iterating between estimation of the covariance associated with the outcomes and generalized-estimating equation estimation of scaled outcomes. Effect size is estimated as Cohen d effect size that was use for the depression outcome is the difference in change from baseline to 12 months in the intervention and usual care groups divided by the pooled base line standard deviation. Thus, a d of 0.25 indicates that one-quarter of a standard deviation separates the two means. Cohen has suggested that an effect size of 0.20 would be considered small, 0.50 medium and 0.80 large.

  • Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months [ Time Frame: Measured at Baseline, 6 Months, 12 months ] [ Designated as safety issue: No ]

    SCL-20 is a 20 question checklist in which items are averaged to yield a potential score of 0 to 4 with higher scores indicating more severe depression symptoms.

    For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.


  • Systolic Blood Pressure at Baseline, 6 Months and 12 Months [ Time Frame: Measured at Baseline, 6 Months, 12 months ] [ Designated as safety issue: No ]

    Systolic Blood Pressure was measured at Baseline, 6 months and 12 months

    For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.


  • LDL Cholesterol at Baseline and 12 Months [ Time Frame: Measured at Baseline and 12 months ] [ Designated as safety issue: No ]

    LDL Cholesterol was measured at Baseline and 12 months

    For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.


  • Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months [ Time Frame: Measured at Baseline, 6 months and 12 months ] [ Designated as safety issue: No ]

    Glycated hemoglobin (HbA1c) was measured at Baseline, 6 months and 12 months

    For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.



Secondary Outcome Measures:
  • Functional Impairment [ Time Frame: Measured at Months 6, 12 months ] [ Designated as safety issue: No ]
    Disability was measured by the Sheehan Disability scale which measures the extent to which health interferes with social, vocational and familial functioning each on a 0 to 10 Likert scale where 0 is "not at all" and 10 is "extremely". This scale consists of 3 items which are averaged together to create the average disability score, which ranges from 0 to 10.

  • Health Care Costs [ Time Frame: Cumulative outpatient costs over 24 months ] [ Designated as safety issue: No ]
    Mean total outpatient costs for 2 years post baseline adjusted for age, gender and previous 12 months of outpatient costs


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: December 13, 2013
Last Updated: May 1, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
major Depressive Disorder
Diabetes
Heart Disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014