Trial Outcomes & Findings for Stroke Education Intervention Trial - Pilot (NCT NCT01115660)

NCT ID: NCT01115660

Last Updated: 2015-10-14

Results Overview

Number of patients contacted at 3 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2015-10-14

Participant Flow

Enrolled patients in 2010 at Wake Forest Baptist Medical Center

Patients assigned to intervention arm and control arm, consecutively.

Participant milestones

Measure	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.	Control Arm Patients received standard discharge counseling but no 2-week follow-up call.
Overall Study STARTED	20	10
Overall Study COMPLETED	19	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stroke Education Intervention Trial - Pilot

Baseline characteristics by cohort

Measure	Stroke Education n=20 Participants Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.	Control Arm n=10 Participants Patients received standard discharge counseling but no 2-week follow-up call.	Total n=30 Participants Total of all reporting groups
Age, Continuous Median Age	61 years INTER_QUARTILE_RANGE 7 • n=93 Participants	59 years INTER_QUARTILE_RANGE 10 • n=4 Participants	61 years INTER_QUARTILE_RANGE 8 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	4 Participants n=4 Participants	12 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	6 Participants n=4 Participants	18 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	10 Participants n=93 Participants	3 Participants n=4 Participants	13 Participants n=27 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants	7 Participants n=4 Participants	16 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	20 participants n=93 Participants	10 participants n=4 Participants	30 participants n=27 Participants

PRIMARY outcome

Timeframe: 3 months

Population: All eligible patients who also were available at 3 months for post-intervention follow-up call.

Number of patients contacted at 3 months

Outcome measures

Measure	Stroke Education n=19 Participants Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.	Control n=10 Participants standard of care
Feasibility of Intervention (Ability to Reach Patients at 3 Months)	16 number of patients contacted	10 number of patients contacted

SECONDARY outcome

Timeframe: 3 months

Population: Patients who were contacted at 3 months

Follow up appointment with primary care provider since stroke

Outcome measures

Measure	Stroke Education n=16 Participants Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.	Control n=10 Participants standard of care
Follow up Appointment With MD	15 participants	7 participants

Adverse Events

Stroke Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cheryl Bushnell

Wake Forest School of Medicine

Phone: (336) 716-2357

Email: cbushnel@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place