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The purpose of this study is to evaluate a program of education, medicine, and monitoring for the treatment of depression after a stroke.
This trial will compare outcomes in depressed patients receiving the Activate-Initiate-Monitor (AIM) intervention vs. those receiving usual care, and will also compare outcomes in depressed and non-depressed stroke survivors. Patients are screened for depression 1 to 2 months post-stroke. Patients with depression are then randomized to the AIM intervention or control group. Patients without depression are also enrolled at the same time and are matched by hospital site to the depressed patients.
The AIM intervention is a 3-part program consisting of activating or educating the patient and his/her family about post-stroke depression, instituting treatment for depression, and monitoring antidepressant treatments for side effects, efficacy, and compliance. Control patients are evaluated and treated with usual care by their physicians. Patients without depression do not receive the intervention but complete the same assessments on the same schedule as the patients with depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse Case management | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| case management | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Twelve Week Depression Outcomes | Depression remission was defined as HAM-D less than 8 or HAM-D decreased by 50%. The Hamilton Rating Scale for Depression is measured on a scale from no depression - major depression, 0-52 units on a scale. | Twelve week |
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| Name | Affiliation | Role |
|---|---|---|
| Linda Williams, M.D. | Roudebush VA Medical Center Health Services Research and Development 11H | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital, 550 N. University Blvd. | Indianapolis | Indiana | 46202 | United States | ||
| Methodist Hospital of Indiana, 1601 N. Capitol |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15677576 | Background | Williams LS, Brizendine EJ, Plue L, Bakas T, Tu W, Hendrie H, Kroenke K. Performance of the PHQ-9 as a screening tool for depression after stroke. Stroke. 2005 Mar;36(3):635-8. doi: 10.1161/01.STR.0000155688.18207.33. Epub 2005 Jan 27. | |
| 16809575 | Background | Williams LS, Bakas T, Brizendine E, Plue L, Tu W, Hendrie H, Kroenke K. How valid are family proxy assessments of stroke patients' health-related quality of life? Stroke. 2006 Aug;37(8):2081-5. doi: 10.1161/01.STR.0000230583.10311.9f. Epub 2006 Jun 29. |
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Subjects were recruited from 4 Indianapolis based hospitals. Depression enrollment and screening occurred between 1 and 2 months post stroke.
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| ID | Title | Description |
|---|---|---|
| FG000 | Case Management |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Case Management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Twelve Week Depression Outcomes | Depression remission was defined as HAM-D less than 8 or HAM-D decreased by 50%. The Hamilton Rating Scale for Depression is measured on a scale from no depression - major depression, 0-52 units on a scale. | Posted | Mean | Standard Deviation | HAM-D depression score | Twelve week |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Case Management |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Linda Williams | Roudebush VAMC Center of Excellence | 317-988-3337 | linda.williams6@va.gov |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003863 | Depression |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019090 | Case Management |
| ID | Term |
|---|---|
| D010347 | Patient Care Planning |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Roudebush VA Medical Center, Health Services Research and Development 11H, 1481 W. 10th Street | Indianapolis | Indiana | 46202 | United States |
| Wishard Memorial Hospital, 1001 W. 10th Street | Indianapolis | Indiana | 46202 | United States |
| 17303771 | Result | Williams LS, Kroenke K, Bakas T, Plue LD, Brizendine E, Tu W, Hendrie H. Care management of poststroke depression: a randomized, controlled trial. Stroke. 2007 Mar;38(3):998-1003. doi: 10.1161/01.STR.0000257319.14023.61. Epub 2007 Feb 15. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 182 |
| 0 |
| 182 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |