StrokePROSPERNCT02146274
Patient-centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research
An observational study of Stroke and Ischemic Stroke, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Ischemic Stroke
- How many people
- 1,877 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 31 Dec 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ischemic Stroke patients
Who may be able to join
- 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.
Who cannot join
- Patients with subarachnoid or intracerebral hemorrhage
- Patients with transient ischemic attack (TIA)
- Patients with expected survival less than 6 months/discharged to hospice
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Institute
Durham, North Carolina, 27705
About this study
Official title: Observational Study of Patient-centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research
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.
Read the 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.
- Conditions
- Stroke, Ischemic Stroke
- Keywords
- PROSPER, Stroke, Ischemic Stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Stroke Patients | Patients who have had an ischemic stroke that are hospitalized in an acute-care setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after enrollment
Secondary outcomes (1)
Functional Status
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
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startNov 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,877 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, American Heart Association
- Responsible party
- Sponsor
- Investigators
- Adrian Hernandez, MD, Principal investigator, DCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146274
- Sponsor's protocol ID
- Pro00049705
- Acronym
- PROSPER
- Status last verified
- Aug 2019
- First submitted
- 21 May 2014
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26232340Xian 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.
PubMed 26093862
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Patient-centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research
- ClinicalTrials.gov ID
- NCT02146274
- Acronym / sponsor ID
- PROSPER / Pro00049705
- Conditions
- Stroke, Ischemic Stroke
- Keywords
- PROSPER, Stroke, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,877 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, American Heart Association
- Study start
- Nov 2013
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Posted 26 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic Stroke Patients | – | –Patients who have had an ischemic stroke that are hospitalized in an acute-care setting. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ischemic Stroke patients
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with subarachnoid or intracerebral hemorrhage
- Patients with transient ischemic attack (TIA)
- Patients with expected survival less than 6 months/discharged to hospice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Functional Status
Time frame: 6 months after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26232340Xian 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.
- Derived from this study: PubMed 26093862Xian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Hernandez, MD principal investigator
DCRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Ischemic Stroke, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02146274, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.