CClinicalTrials.gg
Status unknownNCT02447094STROKE TeleQOLUpdated Feb 9, 2016

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

An observational study in Stroke, sponsored by Thomas Jefferson University. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-09.

Sponsored by Thomas Jefferson University · Observational

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Stroke

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Keywords

  • ischemic
  • tPA
  • tele-medicine
  • robot
  • tele-stroke
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 300 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This research will be performed only in AIS patients who are routinely admitted to our "Hub" and participating "spoke" centers.

Inclusion criteria

  • Patients with suspected acute ischemic stroke (AIS)
  • Age >17 years

Exclusion criteria

Exclusion Criteria:

  • Hemorrhagic strokes (ICH or SAH)
  • Transient ischemic attacks (TIA)
  • Trauma
  • Inability to obtain informed consent
  • Participation in another study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Exposed

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

    Drug: Alteplase

  • Un-exposed

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

Interventions

  • DrugAlteplase

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

    Also known as: Recombinant tissue plasminogen activator (tPA)

06

What researchers measure

Primary outcomes

  1. HRQoL

    Health Related Quality of Life

    Time frame: 6 months

Secondary outcomes

  1. mRS

    Modified Rankin Scale

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Thomas Jefferson University Hospital
    Philadelphia, Pennsylvania 19107, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02447094
Lead sponsor
Thomas Jefferson University
Collaborators
Genentech, Inc.
Responsible party
Fred Rincon (Assistant Professor of Neurology and Neurosurgery, Thomas Jefferson University) — Principal investigator
First posted
May 18, 2015
Start date
Feb 2015
Primary completion
Feb 2017 (estimated)
Last update
Feb 9, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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