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

Study Overview
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Drug: Alteplase


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed<br>AIS patients evaluated through RTP and who receive i.v. tPA | Drug: Alteplase<br>* Intravenous (i.v.) tPA per the standard of care<br>* Other names: Recombinant tissue plasminogen activator (tPA);|
| Un-exposed<br>AIS patients evaluated through RTP and who do not receive i.v. tPA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRQoL | Health Related Quality of Life | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRS | Modified Rankin Scale | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic, tPA, tele-medicine, robot, tele-stroke