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
|Condition or disease|
|Stroke Ischemic Stroke|
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
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||1877 participants|
|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|
Ischemic Stroke Patients
Patients who have had an ischemic stroke that are hospitalized in an acute-care setting.
- 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.
- 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
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
|United States, North Carolina|
|Duke Clinical Research Institute|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Adrian Hernandez, MD||DCRI|