StrokeSTROKE TeleQOLNCT02447094
Quality of Life After Stroke Using a Telemedicine-based Stroke Network
An observational study of Stroke, run by Thomas Jefferson University at 1 site in United States.
Trial summary
To study the effect of a telemedicine model of stroke care on patient-based outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Alteplase
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This research will be performed only in AIS patients who are routinely admitted to our "Hub" and participating "spoke" centers.
Who may be able to join
- Patients with suspected acute ischemic stroke (AIS)
- Age >17 years
Who cannot join
- Hemorrhagic strokes (ICH or SAH)
- Transient ischemic attacks (TIA)
- Trauma
- Inability to obtain informed consent
- Participation in another study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
James P Murphy, 215-503-5739, James.P.Murphy@jefferson.edu
Fred Rincon, MD, MSc
About this study
Official title: Assessing the Impact of Care in A Telemedicine-based Stroke Network Using Patient-Centered Health Related Quality of Life Outcomes
To study the effect of a telemedicine model of stroke care on patient-based outcomes.
Read the detailed description
Approximately 750,000 patients suffer from ischemic stroke (AIS) annually in the United States. AIS is a a leading cause of long-term disability and the third-leading cause of mortality. Effective therapies exist to ameliorate the disability associated with AIS, but implementation of these therapies is time-sensitive. Currently, there is a shortage in health care professionals with expertise in the treatment of stroke and such expertise tends to be concentrated in large community-based or academic medical centers. To respond to this shortage, stroke networks are being organized in a "hub-and-spoke" model to facilitate the rapid delivery of time-sensitive interventions such as intravenous (i.v.) tissue plasminogen activator (tPA) or rapid evaluation for AIS. Some networks are also using telemedicine to facilitate this approach and bring the needed expertise via robotic tele-presence (RTP). Though the accuracy of stroke diagnosis and i.v. tPA utilization may be higher in RTP based networks, the impact of this model on patient's outcomes has been difficult to elucidate. To this end, meaningful validated outcome assessments are crucial to understand the impact of stroke interventions including telemedicine or RTP based networks. The objective of this study is to translate evidence-based practice of healthcare, patient-centered outcome assessments, and patient-family perceptions of delivery of care into meaningful data. This will aid in the validation of the role of interventions such as "hub-and-spoke" RTP based models in stroke care.
- Conditions
- Stroke
- Being tested
- Alteplase
- Keywords
- ischemic, tPA, tele-medicine, robot, tele-stroke
- Medical subject headings
- Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlteplaseDrug
Also called Recombinant tissue plasminogen activator (tPA)
Intravenous (i.v.) tPA per the standard of care
| Study group | Role | What they receive |
|---|---|---|
| Exposed | AIS patients evaluated through RTP and who receive i.v. tPA Receives: Drug: Alteplase | |
| Un-exposed | AIS patients evaluated through RTP and who do not receive i.v. tPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQoL
Health Related Quality of Life
Measured: 6 months
Secondary outcomes (1)
mRS
Modified Rankin Scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Fred Rincon, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447094
- Sponsor's protocol ID
- 15D.044
- Acronym
- STROKE TeleQOL
- Status last verified
- Feb 2016
- First submitted
- 9 May 2015
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Care in A Telemedicine-based Stroke Network Using Patient-Centered Health Related Quality of Life Outcomes
- ClinicalTrials.gov ID
- NCT02447094
- Acronym / sponsor ID
- STROKE TeleQOL / 15D.044
- Conditions
- Stroke
- Keywords
- ischemic, tPA, tele-medicine, robot, tele-stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- First posted
- 18 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effect of a telemedicine model of stroke care on patient-based outcomes.
Detailed description
Approximately 750,000 patients suffer from ischemic stroke (AIS) annually in the United States. AIS is a a leading cause of long-term disability and the third-leading cause of mortality. Effective therapies exist to ameliorate the disability associated with AIS, but implementation of these therapies is time-sensitive. Currently, there is a shortage in health care professionals with expertise in the treatment of stroke and such expertise tends to be concentrated in large community-based or academic medical centers. To respond to this shortage, stroke networks are being organized in a "hub-and-spoke" model to facilitate the rapid delivery of time-sensitive interventions such as intravenous (i.v.) tissue plasminogen activator (tPA) or rapid evaluation for AIS. Some networks are also using telemedicine to facilitate this approach and bring the needed expertise via robotic tele-presence (RTP). Though the accuracy of stroke diagnosis and i.v. tPA utilization may be higher in RTP based networks, the impact of this model on patient's outcomes has been difficult to elucidate. To this end, meaningful validated outcome assessments are crucial to understand the impact of stroke interventions including telemedicine or RTP based networks. The objective of this study is to translate evidence-based practice of healthcare, patient-centered outcome assessments, and patient-family perceptions of delivery of care into meaningful data. This will aid in the validation of the role of interventions such as "hub-and-spoke" RTP based models in stroke care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Drug: AlteplaseAIS patients evaluated through RTP and who receive i.v. tPA |
| Un-exposed | – | –AIS patients evaluated through RTP and who do not receive i.v. tPA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This research will be performed only in AIS patients who are routinely admitted to our "Hub" and participating "spoke" centers.
Key inclusion criteria (2 listed)
- Patients with suspected acute ischemic stroke (AIS)
- Age >17 years
Key exclusion criteria (5 listed)
- Hemorrhagic strokes (ICH or SAH)
- Transient ischemic attacks (TIA)
- Trauma
- Inability to obtain informed consent
- Participation in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlteplaseAlso: Recombinant tissue plasminogen activator (tPA)Intravenous (i.v.) tPA per the standard of care | Drug | Exposed |
Primary outcome
HRQoL
Time frame: 6 months
Health Related Quality of Life
1 secondary outcome
mRS
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
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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.
Thomas Jefferson University Hospital
Philadelphia, United States
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, run by Thomas Jefferson 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 5 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: status not confirmed, as of the sponsor's last update on 9 Feb 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQoL (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2016; AzTrials last refreshed its copy on 6 Nov 2026.