Quality of Life After Stroke Using a Telemedicine-based Stroke Network

NCT ID: NCT02447094

Last Updated: 2016-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Brief Summary

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

Detailed Description

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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

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposed

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

Alteplase

Intervention Type DRUG

Intravenous (i.v.) tPA per the standard of care

Un-exposed

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

No interventions assigned to this group

Interventions

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Alteplase

Intravenous (i.v.) tPA per the standard of care

Intervention Type DRUG

Other Intervention Names

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Recombinant tissue plasminogen activator (tPA)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Fred Rincon

Assistant Professor of Neurology and Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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James P Murphy

Role: primary

215-503-5739

Other Identifiers

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15D.044

Identifier Type: -

Identifier Source: org_study_id

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