Intracranial Hemorrhage, Ischemic Stroke, Transient Ischemic Attack
Conditions
Keywords
stroke, patient education, medication adherence
Brief summary
The objectives of the trial of a medication-coach program for patients with stroke or transient ischemic attack are to pilot test the study design, the intervention components and the data collection forms and refine them for a larger trial whose goal will be to improve long-term adherence to stroke prevention medications.
Interventions
BEHAVIORALstroke education
call by medication coach 2 weeks after hospital discharge
Sponsors
Wake Forest University Health Sciences
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at Wake Forest University Baptist Medical Center (WFUBMC) over age 18 * Diagnosed with acute ischemic stroke, transient ischemic attack or intracranial hemorrhage * provide consent to participate
Exclusion criteria
* discharged to nursing home, acute rehabilitation center, inpatient hospice, or other acute hospital * homeless * non-English speakers * patient and proxy unable to participate in telephone conversation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention (Ability to Reach Patients at 3 Months) | 3 months | Number of patients contacted at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follow up Appointment With MD | 3 months | Follow up appointment with primary care provider since stroke |
Countries
United States
Participant flow
Recruitment details
Enrolled patients in 2010 at Wake Forest Baptist Medical Center
Pre-assignment details
Patients assigned to intervention arm and control arm, consecutively.
Participants by arm
| Arm | Count |
|---|---|
| Stroke Education Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen. | 20 |
| Control Arm Patients received standard discharge counseling but no 2-week follow-up call. | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Stroke Education | Total | Control Arm |
|---|---|---|---|
| Age, Continuous Median Age | 61 years INTER_QUARTILE_RANGE 7 | 61 years INTER_QUARTILE_RANGE 8 | 59 years INTER_QUARTILE_RANGE 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 13 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 16 Participants | 7 Participants |
| Region of Enrollment United States | 20 participants | 30 participants | 10 participants |
| Sex: Female, Male Female | 8 Participants | 12 Participants | 4 Participants |
| Sex: Female, Male Male | 12 Participants | 18 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Feasibility of Intervention (Ability to Reach Patients at 3 Months)
Number of patients contacted at 3 months
Time frame: 3 months
Population: All eligible patients who also were available at 3 months for post-intervention follow-up call.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stroke Education | Feasibility of Intervention (Ability to Reach Patients at 3 Months) | 16 number of patients contacted |
| Control | Feasibility of Intervention (Ability to Reach Patients at 3 Months) | 10 number of patients contacted |
Secondary
Follow up Appointment With MD
Follow up appointment with primary care provider since stroke
Time frame: 3 months
Population: Patients who were contacted at 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stroke Education | Follow up Appointment With MD | 15 participants |
| Control | Follow up Appointment With MD | 7 participants |