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

NCT00468676 | Completed Results DMC

• 2 other identifiers: R01MH041739DSIR 82-SEPC
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

major Depressive Disorder; Diabetes; Heart Disease

Outcome Measures

Primary Outcomes (5)

• Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c

  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.

  Baseline to 12 months

• Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months

  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.

  Measured at Baseline, 6 Months, 12 months

• Systolic Blood Pressure at Baseline, 6 Months and 12 Months

  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.

  Measured at Baseline, 6 Months, 12 months

• LDL Cholesterol at Baseline and 12 Months

  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.

  Measured at Baseline and 12 months

• Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months

  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.

  Measured at Baseline, 6 months and 12 months

Secondary Outcomes (2)

• Functional Impairment

  Measured at Months 6, 12 months

• Health Care Costs

  Cumulative outpatient costs over 24 months

Study Arms (2)

B

ACTIVE COMPARATOR

Treatment as usual

Behavioral: Treatment as usual

A

EXPERIMENTAL

Case management intervention

Behavioral: Nurse-led case management

Interventions

Nurse-led case management BEHAVIORAL

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.

A

Treatment as usual BEHAVIORAL

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

B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Group Health Cooperative

Seattle, Washington, 98101, United States

Location

Related Publications (5)

• 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. doi: 10.1056/NEJMoa1003955.

  PMID: 21190455 RESULT

• Lin EH, Von Korff M, Ciechanowski P, Peterson D, Ludman EJ, Rutter CM, Oliver M, Young BA, Gensichen J, McGregor M, McCulloch DK, Wagner EH, Katon WJ. Treatment adjustment and medication adherence for complex patients with diabetes, heart disease, and depression: a randomized controlled trial. Ann Fam Med. 2012 Jan-Feb;10(1):6-14. doi: 10.1370/afm.1343.

  PMID: 22230825 RESULT

• 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. doi: 10.1136/bmj.d6612.

  PMID: 22074851 RESULT

• Katon W, Russo J, Lin EH, Schmittdiel J, Ciechanowski P, Ludman E, Peterson D, Young B, Von Korff M. Cost-effectiveness of a multicondition collaborative care intervention: a randomized controlled trial. Arch Gen Psychiatry. 2012 May;69(5):506-14. doi: 10.1001/archgenpsychiatry.2011.1548.

  PMID: 22566583 RESULT

• Ludman EJ, Peterson D, Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Young B, Gensichen J. Improving confidence for self care in patients with depression and chronic illnesses. Behav Med. 2013;39(1):1-6. doi: 10.1080/08964289.2012.708682.

  PMID: 23398269 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Diabetes Mellitus; Heart Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases

Limitations and Caveats

Limitations include the study being completed in one health care system in one geographic area, inadequate power to determine cardiovascular events or rates of hospitalization, potential "spill-over of intervention to usual care patients.

Results Point of Contact

• Title: Dr Wayne Katon, Professor and Vice Chair
• Organization: Dept Psychiatry, University of Washington Medical School

wkaton@uw.edu

206-543-7177

Study Officials

• Wayne J. Katon, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice Chair University of Washington

Study Record Dates

• First Submitted: May 1, 2007
• First Posted: May 3, 2007
• Study Start: May 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: August 1, 2012
• Last Updated: May 2, 2014
• Results First Posted: May 2, 2014

Record last verified: 2014-05

Locations

US (1)