Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression
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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 |
- 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 ]
- 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 |
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| United States, Washington | |
| Group Health Cooperative | |
| Seattle, Washington, United States, 98101 | |
| 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 June 17, 2013