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

NCT02146274 | Completed Results

• 1 other identifier: Pro00049705
• Study Type: observational
• Target: 1,877
• Locations: 1 country
• Sites: 1

Brief Summary

PROSPER (Patient-centered Research into Outcomes Stroke patients Prefer and Effectiveness Research) is a three year research project to create a national, sustainable model to improve decision-making and patient-centered stroke outcomes through comparative effectiveness research.

Conditions

Stroke; Ischemic Stroke

Keywords

PROSPER; Stroke; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Depression

  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.

  6 months after enrollment

Secondary Outcomes (1)

• Functional Status

  6 months after enrollment

Study Arms (1)

Ischemic Stroke Patients

Patients who have had an ischemic stroke that are hospitalized in an acute-care setting.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ischemic Stroke patients

You may qualify if:

• Ability to give informed consent or the availability of a surrogate who can consent on the patient's behalf.

You may not qualify if:

• Patients with subarachnoid or intracerebral hemorrhage
• Patients with transient ischemic attack (TIA)
• Patients with expected survival less than 6 months/discharged to hospice

Sponsors & Collaborators

• Duke University: lead
• Patient-Centered Outcomes Research Institute: collaborator
• American Heart Association: collaborator

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

• Xian Y, Wu J, O'Brien EC, Fonarow GC, Olson DM, Schwamm LH, Bhatt DL, Smith EE, Suter RE, Hannah D, Lindholm B, Maisch L, Greiner MA, Lytle BL, Pencina MJ, Peterson ED, Hernandez AF. Real world effectiveness of warfarin among ischemic stroke patients with atrial fibrillation: observational analysis from Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) study. BMJ. 2015 Jul 31;351:h3786. doi: 10.1136/bmj.h3786.

  PMID: 26232340 DERIVED

• Xian Y, O'Brien EC, Fonarow GC, Olson DM, Schwamm LH, Hannah D, Lindholm B, Maisch L, Lytle BL, Greiner MA, Wu J, Peterson ED, Pencina MJ, Hernandez AF. Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research: Implementing the patient-driven research paradigm to aid decision making in stroke care. Am Heart J. 2015 Jul;170(1):36-45, 45.e1-11. doi: 10.1016/j.ahj.2015.04.008. Epub 2015 Apr 18.

  PMID: 26093862 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

6 month prospective observational study. Patients not randomized

Results Point of Contact

• Title: Vice Dean of Clinical Research
• Organization: Duke University School of Medicine

awindham@duke.edu

919-684-4979

Study Officials

• Adrian Hernandez, MD

  DCRI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 23, 2014
• Study Start: November 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 6, 2019
• Results First Posted: July 26, 2019

Record last verified: 2019-08

Locations

US (1)