Trial Outcomes & Findings for Patient-centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (NCT NCT02146274)

NCT ID: NCT02146274

Last Updated: 2019-08-06

Results Overview

Patient Health Questionnaire - 2 Item (PHQ-2) Higher score suggests more depression; range of 0-6. A score of two or higher suggests a diagnosis of major depression.

• Recruitment status: COMPLETED
• Target enrollment: 1877 participants
• Primary outcome timeframe: 6 months after enrollment
• Results posted on: 2019-08-06

Participant Flow

Observational survey

Participant milestones

Measure	Ischemic Stroke Patients Patients who have had an ischemic stroke
Overall Study STARTED	1877
Overall Study COMPLETED	1804
Overall Study NOT COMPLETED	73

Reasons for withdrawal

Measure	Ischemic Stroke Patients Patients who have had an ischemic stroke
Overall Study Protocol Violation	73

Baseline Characteristics

Patient-centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research

Baseline characteristics by cohort

Measure	Ischemic Stroke Patients n=1617 Participants Patients who have had an ischemic stroke
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	760 Participants n=5 Participants
Sex: Female, Male Male	857 Participants n=5 Participants
Race/Ethnicity, Customized race · white	1229 Participants n=5 Participants
Race/Ethnicity, Customized race · black	227 Participants n=5 Participants
Race/Ethnicity, Customized race · hispanic	65 Participants n=5 Participants
Race/Ethnicity, Customized race · asian	32 Participants n=5 Participants
Race/Ethnicity, Customized race · other/utd	64 Participants n=5 Participants
Antidepressant at Discharge Antidepressant - Yes	185 Participants n=5 Participants
Antidepressant at Discharge Antidepressant - No	1432 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after enrollment

Patient Health Questionnaire - 2 Item (PHQ-2) Higher score suggests more depression; range of 0-6. A score of two or higher suggests a diagnosis of major depression.

Outcome measures

Measure	Ischemic Stroke Patients By Anti-depressant =Yes n=185 Participants Patients on Antidepressant at Discharge	Ischemic Stroke Patients By Anti-depressant =No n=1432 Participants Patients not on Antidepressant at Discharge
Depression	.7 units on a scale Standard Deviation .22	.79 units on a scale Standard Deviation .21

SECONDARY outcome

Timeframe: 6 months after enrollment

Population: Comparing functional status of ischemic stroke patients who are and are not taking an antidepressant 6 months post enrollment

Euro-QOL ver. 5D-3L (EQ 5D-3L) EQ-5D-3L Five level version of the Euro-QOL. Index Value ranging from 0-1.0 Higher scores indicate better functioning

Outcome measures

Measure	Ischemic Stroke Patients By Anti-depressant =Yes n=222 Participants Patients on Antidepressant at Discharge	Ischemic Stroke Patients By Anti-depressant =No n=760 Participants Patients not on Antidepressant at Discharge
Functional Status	0.77 score on scale Interval 0.47 to 0.83	0.83 score on scale Interval 0.71 to 1.0

Adverse Events

Ischemic Stroke Patients

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

Vice Dean of Clinical Research

Duke University School of Medicine

Phone: 919-684-4979

Email: awindham@duke.edu

Results disclosure agreements

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