Clinical trial NCT00468676: Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression
Official title: Randomized Trial of Liaison Psychiatry in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: major Depressive Disorder
Diabetes
Heart Disease
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-05-03
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c
timeFrame: Baseline to 12 months
measure: Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months
timeFrame: Measured at Baseline, 6 Months, 12 months
measure: Systolic Blood Pressure at Baseline, 6 Months and 12 Months
timeFrame: Measured at Baseline, 6 Months, 12 months
measure: LDL Cholesterol at Baseline and 12 Months
timeFrame: Measured at Baseline and 12 months
measure: Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months
timeFrame: Measured at Baseline, 6 months and 12 months
Secondary outcomes:
measure: Functional Impairment
timeFrame: Measured at Months 6, 12 months
measure: Health Care Costs
timeFrame: Cumulative outpatient costs over 24 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Cooperative
state: Washington
Study officials:
affiliation: University of Washington
name: Wayne J. Katon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.