STROKE TeleQOL: Quality of Life After Stroke Using a Telemedicine-based Stroke Network

Sponsor
Thomas Jefferson University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02447094
Collaborator
Genentech, Inc. (Industry)
300
1

Study Details

Study Description

Brief Summary

To study the effect of a telemedicine model of stroke care on patient-based outcomes.

Condition or Disease Intervention/Treatment Phase

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

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessing the Impact of Care in A Telemedicine-based Stroke Network Using Patient-Centered Health Related Quality of Life Outcomes
Study Start Date :
Feb 1, 2015
Anticipated Primary Completion Date :
Feb 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Exposed

AIS patients evaluated through RTP and who receive i.v. tPA

Drug: Alteplase
Intravenous (i.v.) tPA per the standard of care
Other Names:
  • Recombinant tissue plasminogen activator (tPA)
  • Un-exposed

    AIS patients evaluated through RTP and who do not receive i.v. tPA

    Outcome Measures

    Primary Outcome Measures

    1. HRQoL [6 months]

      Health Related Quality of Life

    Secondary Outcome Measures

    1. mRS [6 months]

      Modified Rankin Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with suspected acute ischemic stroke (AIS)

    • Age >17 years

    Exclusion Criteria:
    • Hemorrhagic strokes (ICH or SAH)

    • Transient ischemic attacks (TIA)

    • Trauma

    • Inability to obtain informed consent

    • Participation in another study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Thomas Jefferson University
    • Genentech, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Fred Rincon, Assistant Professor of Neurology and Neurosurgery, Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT02447094
    Other Study ID Numbers:
    • 15D.044
    First Posted:
    May 18, 2015
    Last Update Posted:
    Feb 9, 2016
    Last Verified:
    Feb 1, 2016
    Keywords provided by Fred Rincon, Assistant Professor of Neurology and Neurosurgery, Thomas Jefferson University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 9, 2016