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| ID | Type | Description | Link |
|---|---|---|---|
| 5132-03-8R0ER | Other Identifier | Duke legacy protocol ID |
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Terminated
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Purpose of the Study: The significant impact of depression on the poor prognosis and functional restrain, recognition and successful treatment of depression in patients with Chronic Heart Failure (CHF) may result in improvement of overall outcome of those patients. However, depression comorbid with CHF has been overlooked in the real practice. Therefore, the investigators are proposing a study to 1) assess the prognostic impact of depression in patients with stable CHF who have been managed as outpatients, and 2) assess whether provision of depression education to CHF patients will improve the care of depression.
Patients with chronic heart failure are enrolled into this study with a half of them are randomly assigned to receive a packet of depression education materials and then other half not. Participants and investigators both are blinded to the assignment. All the participants are provided a toll free phone number to contact the research team as needed. Depressive symptoms and patients knowledge of depression are assessed at baseline prior to randomization and at 1-month and 6-month following the enrollment.
Responses of the study participants, such as change of depressive symptoms, and requests for psychiatric help are examined between two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational materials | Experimental | Receiving educational materials of depression care |
|
| No educational materials | Sham Comparator | Receiving an envelope but no inclusion of educational materials of depression care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Receiving educational material of depression care | Behavioral | The educational material provides patients about depression management |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in recognition of study participant to depression care | To assess whether the provision of depression education materials will increase knowledge of the impact depression has on Congestive Heart Failure patients. This will be measured through study participants completion of a questionnaire to record their views on depression and depression care in a non-psychiatric setting. | Baseline, 1 month and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in response of study participant to depression care | Response of participants to depression care was measured by use of the Beck Depression Inventory scale (BDI), PHQ-9 (the 9 items of the depression scale of the Patient Health Questionnaire) and an anxiety questionnaire and a toll-free contact number to access free psychiatric consultants at the coordinating center. A contact log was kept documenting subject ID, reason for call, number of contacts and duration of the call. |
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Inclusion Criteria:
Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Jiang, MD | Duke University | Principal Investigator |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003863 | Depression |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Baseline, 1 month, and 6 months |