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| Descriptive Information Fields | |||||||||
| Brief Title † | Nurse-Led Case Management for Diabetes and Cardiovascular Disease Patients With Depression | ||||||||
| Official Title † | Randomized Trial of Liaison Psychiatry in Primary Care | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | 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 ] |
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| Secondary Outcome Measure † | 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 ] |
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| Condition † | Depression | ||||||||
| Intervention † | Behavioral: Nurse-led case management Behavioral: Treatment as usual |
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| MEDLINE PMIDs | 15466678 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 300 | ||||||||
| Start Date † | May 2007 | ||||||||
| Completion Date | June 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00468676 | ||||||||
| Organization ID | R01 MH41739 | ||||||||
| Secondary IDs †† | DSIR 82-SEPC | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | April 2008 | ||||||||
| First Received Date † | May 1, 2007 | ||||||||
| Last Updated Date | April 1, 2008 | ||||||||
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