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Trial record 1 of 2 for:    PROSPER STROKE
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Patient-centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER)

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ClinicalTrials.gov Identifier: NCT02146274
Recruitment Status : Completed
First Posted : May 23, 2014
Results First Posted : July 26, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
American Heart Association
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
Stroke Ischemic Stroke

Detailed Description:

We propose to address existing evidence gaps and develop the requested data on the range of clinical outcomes that may be experienced by stroke survivors. To achieve these goals, we will link the nation's largest stroke registry, the American Heart Association (AHA) Get With The Guidelines-Stroke program and nationwide Medicare claims data, coupled with telephone interviews for longitudinal treatment and downstream patient-reported outcomes.

Design & Procedures:

Retrospective: Using GWTG-Stroke database and its associated 1900 hospitals, we will conduct several comparative research protocols prioritized by stroke survivor focus groups and surveys. GWTG-Stroke registry clinical data linked with Medicare claims will be used for analysis of effectiveness and safety of post-stroke therapies on long-term clinical outcomes (n= 450,000). Outcomes of interest include:

"Home-time" (days alive and at home) Death Stroke/TIA readmission All-cause readmission Cardiovascular readmission Bleeding readmission

Prospective:

We will use the existing AVAIL registry combined with an additional 2000 stroke survivors for a combined cohort of over 5000 patients to obtain detailed information on patient-reported outcomes. The AVAIL Registry (IRB # Pro00012243) collected data from 3000 stroke survivors between 2006 and 2008. We plan to use these data to supplement our prospective PROSPER study. The PROSPER study will enroll a minimum of 2,000 subjects to augment the data collected from the AVAIL study. Consented patients from at least 75 sites will complete interviews at 3 and 6 months after discharge. We anticipate that the PROSPER questionnaire will include the following tools: Fatigue Severity Scale (FSS), Patient Health Questionnaire (PHQ8), modified Rankin scale (mRS), Barthel Index, EuroQOL (EQ-5D), Stroke-specific quality of life (SSQOL-12) and Lawton Instrumental Activities of Daily Living (IADL). Sites will consent interested patients and have them complete a patient contact information form which includes, name, address, phone numbers, email address, etc. Outcomes of interest include: : Post-stroke fatigue, Depression, Chronic pain, Medication intolerance, Modified Rankin scale (mRS), EuroQOL and Stroke-specific quality of life.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 1877 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Observational Study of Patient-centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research
Study Start Date : November 2013
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Group/Cohort
Ischemic Stroke Patients
Patients who have had an ischemic stroke that are hospitalized in an acute-care setting.



Primary Outcome Measures :
  1. Depression [ Time Frame: 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.


Secondary Outcome Measures :
  1. Functional Status [ Time Frame: 6 months after 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Ischemic Stroke patients
Criteria

Inclusion Criteria:

  • Consistent with GWTG inclusion criteria, patients must be older than 18 and have a primary diagnosis of acute ischemic stroke.
  • Ability to give informed consent or the availability of a surrogate who can consent on the patient's behalf.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146274


Locations
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United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Patient-Centered Outcomes Research Institute
American Heart Association
Investigators
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Principal Investigator: Adrian Hernandez, MD DCRI
  Study Documents (Full-Text)

Documents provided by Duke University:
Study Protocol  [PDF] February 26, 2014
Statistical Analysis Plan  [PDF] May 24, 2017


Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02146274     History of Changes
Other Study ID Numbers: Pro00049705
First Posted: May 23, 2014    Key Record Dates
Results First Posted: July 26, 2019
Last Update Posted: August 6, 2019
Last Verified: August 2019

Keywords provided by Duke University:
PROSPER
Stroke
Ischemic Stroke

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases