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

Stroke Clinical Trial

— STROKE TeleQOL  

Official title:

Assessing the Impact of Care in A Telemedicine-based Stroke Network Using Patient-Centered Health Related Quality of Life Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02447094
• Other study ID #: 15D.044
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2015
• Last updated: February 8, 2016
• Start date: February 2015

Study information

• Verified date: February 2016
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Alteplase
Intravenous (i.v.) tPA per the standard of care

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HRQoL	Health Related Quality of Life	6 months	No
Secondary	mRS	Modified Rankin Scale	6 months	No

External Links

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