Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00623350
Other study ID # 06-005731
Secondary ID
Status Completed
Phase N/A
First received February 15, 2008
Last updated May 11, 2011
Start date December 2007
Est. completion date January 2009

Study information

Verified date May 2011
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Noninvasive prospective multi-center study of an interactive 2-way, wireless or site-independent, audiovisual telemedicine system designed for real-time remote examination of acute stroke symptoms and deficits as a basis for treatment consultation and recommendation.

Study aims (1) to determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics; (2) to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only; (3) to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations; and (4) to assess the completeness of the data collection in telemedicine versus telephone-only consultations.

60 patients in Arizona with acute presentation of stroke symptoms, per bedside practitioner discretion (onset generally less than 12 hours and likely less than 3 hours)

Two arms: Video Camera/Telemedicine (Intervention n = 30) and No Video Camera/Telephone only (Control n = 30)


Description:

Design

Noninvasive prospective multi-center study of an interactive 2-way, wireless or site-independent, audiovisual telemedicine system designed for real-time remote examination of acute stroke symptoms and deficits as a basis for treatment consultation and recommendation.

Study aims (1) to determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics; (2) to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only; (3) to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations; and (4) to assess the completeness of the data collection in telemedicine versus telephone-only consultations.

60 patients in Arizona with acute presentation of stroke symptoms, per bedside practitioner discretion (onset generally less than 12 hours and likely less than 3 hours)

Two arms: Video Camera/Telemedicine (Intervention n = 30) and No Video Camera/Telephone only (Control n = 30)

Assessments

All cases will undergo the following assessments:

Patient-Level Visits

Baseline: Pre-stroke Modified Rankin Scale (demographics), pre-treatment Modified Rankin Scale, medications during prior 3 days, physical exam and vital signs, NIHSS, Modified NIHSS, EKG, screening labs, and head CT scan

Treatment: Treatment times, thrombolytic safety outcome, and recanalization treatment

Day 90: Modified Rankin Scale, Barthel Index, and mortality

End of Study: End of study/Termination

Meta-Level Reviews

Adjudication: Post case completion, review and evaluation of each remote consultation on whether the recommendation for or against thrombolytic therapy was appropriate, given the information presented at each of 3 levels of adjudication.

Central Read: Post case completion, review and evaluation of each Baseline head CT scan interpretation on whether there was a CT contraindication to thrombolytic therapy.

Trial Groups

There will be two trial groups in this study. The investigators hypothesized (based upon sample size calculations) that the correct treatment will be recommended at rates of 80% (telephone) and 90% (full telemedicine).

Target Population

60 AZ patients will be randomized to either telephone-only or video telemedicine consultation. Appropriateness of therapeutic decision-making, numbers treated, time to treatment, and completeness of data collection will be evaluated and compared for each group.

If the protocol or grant application is investigator-initiated, a 200-word (or less) abstract of the proposed protocol or grant application must be included (an abstract included in an NIH or other submission is acceptable). If the protocol is sponsor initiated, a summary written by the Mayo investigator must be included. Summary should include: 1) Hypothesis, 2) Basic study plan, 3) Statistical method/rationale, 4) Scientific basis or justification, 5) Inclusion/exclusion criteria, and 6) Monetary consideration. You may type or cut and paste from an existing document to address this question

Objectives

1. to determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics;

2. to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only;

3. to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations; and

4. to assess the completeness of the data collection in telemedicine versus telephone-only consultations.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Subject Inclusion Criteria

For inclusion in the study, subjects must fulfill all of the following criteria:

- Written Informed Consent

- Eighteen years of age or older

- Symptoms consistent with acute stroke (ischemic or hemorrhagic)

- Acute presentation of stroke symptoms, per bedside physician discretion (onset generally less than 12 hours and likely less than 3 hours)

Subject Exclusion Criteria

The following is the sole criterion for exclusion from the study:

- Unlikely to complete study through 90-day follow-up

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Telephone
Acute Stroke consult by Telephone for the decision of tPA within 3 hours of symptom onset.
Two way audio/video telemedicine consult
Acute Stroke consult by two way audio video telemedicine for the decision of tPA within 3 hours of symptom onset.

Locations

Country Name City State
United States Mayo Clinic Phoenix Arizona

Sponsors (5)

Lead Sponsor Collaborator
Mayo Clinic Arizona Department of Health Services, Kingman Regional Medical Center, University of California, San Diego, Yuma Regional Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Demaerschalk BM, Bobrow BJ, Raman R, Kiernan TE, Aguilar MI, Ingall TJ, Dodick DW, Ward MP, Richemont PC, Brazdys K, Koch TC, Miley ML, Hoffman Snyder CR, Corday DA, Meyer BC; STRokE DOC AZ TIME Investigators. Stroke team remote evaluation using a digital — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary to determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics 90 days No
Primary to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only 90 days No
Primary to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations 90 days No
Primary to assess the completeness of the data collection in telemedicine versus telephone-only consultations. 90 days No
See also
  Status Clinical Trial Phase
Recruiting NCT05378035 - DOAC in Chinese Patients With Atrial Fibrillation
Completed NCT03679637 - Tablet-based Aphasia Therapy in the Acute Phase After Stroke N/A
Completed NCT03574038 - Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke N/A
Completed NCT03633422 - Evaluation of Stroke Patient Screening
Completed NCT04088578 - VNS-supplemented Motor Retraining After Stroke N/A
Not yet recruiting NCT05534360 - Tenecteplase Treatment in Ischemic Stroke Registry
Withdrawn NCT04991038 - Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients N/A
Withdrawn NCT05786170 - ERILs Und SNILs Unter SOC N/A
Not yet recruiting NCT04105322 - Effects of Kinesio Taping on Balance and Functional Performance in Stroke Patients N/A
Recruiting NCT03132558 - Contrast Induced Acute Kidney in Patients With Acute Stroke N/A
Completed NCT02893631 - Assessment of Hemostasis Disorders in rtPA-treated Patients Requiring Endovascular Treatment for Ischemic Stroke
Active, not recruiting NCT02274727 - Biomarker Signature of Stroke Aetiology Study: The BIOSIGNAL-Study
Completed NCT02225730 - Imaging Collaterals in Acute Stroke (iCAS)
Terminated NCT01705353 - The Role of HMGB-1 in Chronic Stroke N/A
Active, not recruiting NCT01581502 - SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF) N/A
Completed NCT01182818 - Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease N/A
Completed NCT00761982 - Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment. Phase 1/Phase 2
Completed NCT00535197 - Autologous Bone Marrow Stem Cells in Ischemic Stroke. Phase 1/Phase 2
Terminated NCT00132509 - FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke Phase 2
Recruiting NCT05760326 - Diagnostic and Prognostic Role of Clot Analysis in Stroke Patients