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

• Conditions: Stroke
• Interventions: Drug: Alteplase

• Registration Number: NCT02447094
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-05-09
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-18
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09
• Primary Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed	Alteplase	AIS patients evaluated through RTP and who receive i.v. tPA

Primary Outcome Measures

Name	Time	Method
HRQoL	6 months	Health Related Quality of Life

Secondary Outcome Measures

Name	Time	Method
mRS	6 months	Modified Rankin Scale

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States