Depression, Stroke
Conditions
Keywords
stroke, depression
Brief summary
The purpose of this study is to evaluate a program of education, medicine, and monitoring for the treatment of depression after a stroke.
Detailed description
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.
Interventions
OTHERcase management
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* No severe language or cognitive deficits, * life expectancy of at least 9 months, and * willingness to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Twelve Week Depression Outcomes | Twelve week | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 4 Indianapolis based hospitals. Depression enrollment and screening occurred between 1 and 2 months post stroke.
Participants by arm
| Arm | Count |
|---|---|
| Case Management | 182 |
| Total | 182 |
Baseline characteristics
| Characteristic | Case Management |
|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 182 participants |
| Sex: Female, Male Female | 99 Participants |
| Sex: Female, Male Male | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 182 |
| serious Total, serious adverse events | 0 / 182 |
Outcome results
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.
Time frame: Twelve week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Case Management | Twelve Week Depression Outcomes | 10.6 HAM-D depression score | Standard Deviation 6.9 |