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CompletedNCT00829361STARRUpdated Nov 25, 2015

Stroke Telemedicine for Arizona Rural Residents Trial

An interventional study of Telemedicine in Stroke, Cerebral Infarction and Vascular Diseases, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2015-11-25.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
447
Allocation
Not applicable
Ages
18 Years to 120 Years
Sex
All
01

Study summary

The STARR network registry consists of a 4 spoke 1 hub system. Which will consist of prospective collection, recording, and regular analysis of telestroke patient consultation and care data for the purpose of quality measure assessment and improvement and benchmarking against other national and international telestroke programs.

Read the detailed description

Background:

Acute stroke resources and care are deficient in Arizona's rural communities. Stroke telemedicine is a proven modality for overcoming the deficiency. Stroke telemedicine allows a telephonic consultation and/or two-way audio video consultation between a stroke neurologist and a stroke patient at a remotely located emergency department. University of California San Diego Stroke Center has completed an NIH funded randomized controlled trial, STRokE DOC, comparing telephonic consultations to video consultations. In that trial, video telemedicine consultations resulted in more accurate decision making compared with telephone consultations. The video telemedicine consultative modality provides the rural stroke patient with the opportunity to receive expert stroke care, interpretation of neuroimaging, determination of appropriate acute therapy, and recommendations regarding need for transfer to a higher level of care. Mayo Clinic Arizona is currently completing a state funded feasibility trial, STRokE DOC Arizona (06-005731), as a preliminary step toward establishing a state wide stroke telemedicine network, STARR. The STARR network plan should include the prospective collection, recording, and regular analysis of telestroke patient consultation data for the purpose of quality measure assessment and improvement.

Objective:

The objective of this research is to establish a system for the prospective collection, recording, and regular analysis of telestroke patient consultation and care data for the purpose of quality measure assessment and improvement and benchmarking against other national and international telestroke programs.

Methods:

The STARR network consists of a primary stroke center hub (Mayo Clinic Hospital) that serves multiple spoke hospitals in remote and rural regions of the state (e.g. Kingman and Yuma Regional Medical Centers, La Paz Regional Hospital and Copper Queen Community Hospital). Mayo Clinic vascular neurologists, who have licenses and privileges to practice teleneurology at spoke hospitals in the state, participate in a 24/7 Mayo Clinic telestroke hotline. When an acute stroke patient presents to a STARR network participating spoke hospital emergency department, a stroke alert is activated and the hotline is phoned. An on-call vascular neurologist receives the pager notification and communicates with the referring emergency physician. The telestroke consultation will begin by telephone and will be supplemented by audio-video telemedicine communication and teleradiology. The patient is registered at Mayo Clinic and a registration number is generated by the house supervisor. Emergency neurology care is rendered. Every participating spoke hospital emergency physician is already a sub-investigator in telestroke research and has completed HSRP training and certification. The Mayo Clinic IRB has served as the central IRB of record for state funded Mayo Clinic telestroke research. The patient or legal designate will be approached by either the spoke emergency physician investigator and/or the hub neurologist investigator (via telemedicine camera) for consent to proceed with telestroke consultation, and to acquire, store, and analyze data concerning the acute stroke care and outcome of the patient. Data sources will include the Mayo Clinic electronic transcribed telestroke consultation note, the emergency department nursing and physician records, the admission consultation and diagnostic tests records, hospital discharge note, and the content of a brief 90 day follow-up phone call by the research coordinator to patient and/or family member. The licensed neurologists already have authorization to access patient spoke hospital records as part of their clinical privileges, but the designated Mayo Clinic research coordinator will have the responsibility to extract data from the sources and enter it into the registry. The STARR registry data elements will be exactly the same as the established and familiar data elements for the STRokE DOC Arizona trial, for the purposes of continuity. Mayo Clinic Arizona research biostatistics group will develop the electronic data manager and conduct and report analyses monthly to the telestroke research group.

02

Conditions studied

  • Stroke
  • Cerebral Infarction
  • Vascular Diseases
  • Brain Ischemia
  • Brain Infarction
  • Brain Diseases
  • Cerebrovascular Disorders

Keywords

  • Telemedicine
  • Acute stroke
  • Rural
  • thrombosis
  • consultation
  • Stroke
  • Cerebral Infarction
  • Vascular diseases
  • brain ischemia
  • brain infarction
  • brain diseases
  • cerebrovascular disorders
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In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 447 is above the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.

Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients presenting to Rural Emergency Department within 12 hours of acute stroke symptom onset.
  • Written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Unlikely to complete study through 90-day follow-up.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
447 participants (actual)

Study arms

  • Other
    Telemedicine

    Other: Telemedicine

Interventions

  • OtherTelemedicine

    Two way site independent audio/video telemedicine system with DICOM.

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What researchers measure

Primary outcomes

  1. To assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine

    Time frame: 90 days

Secondary outcomes

  1. To assess the functional outcomes of acute stroke subjects by Barthel index and Modified Rankin Scale

    Time frame: 90 days

  2. To assess the rate of intracranial hemorrhage post thrombolysis

    Time frame: 90 days

07

Study locations

1 site
  • Mayo Clinic Hospital
    Phoenix, Arizona 85054, United States
08

References and documents

Publications

  • Demaerschalk BM, Aguilar MI, Ingall TJ, Dodick DW, Vargas BB, Channer DD, Boyd EL, Kiernan TEJ, Fitz-Patrick DG, Collins JG, Hentz JG, Noble BN, Wu Q, Brazdys K, Bobrow BJ. Stroke Telemedicine for Arizona Rural Residents, the Legacy Telestroke Study. Telemed Rep. 2022 Mar 14;3(1):67-78. doi: 10.1089/tmr.2022.0002. eCollection 2022. PubMed 35720454 ↗
  • Demaerschalk BM, Vargas JE, Channer DD, Noble BN, Kiernan TE, Gleason EA, Vargas BB, Ingall TJ, Aguilar MI, Dodick DW, Bobrow BJ. Smartphone teleradiology application is successfully incorporated into a telestroke network environment. Stroke. 2012 Nov;43(11):3098-101. doi: 10.1161/STROKEAHA.112.669325. Epub 2012 Sep 11. PubMed 22968466 ↗
  • Capampangan DJ, Wellik KE, Bobrow BJ, Aguilar MI, Ingall TJ, Kiernan TE, Wingerchuk DM, Demaerschalk BM. Telemedicine versus telephone for remote emergency stroke consultations: a critically appraised topic. Neurologist. 2009 May;15(3):163-6. doi: 10.1097/NRL.0b013e3181a4b79c. PubMed 19430275 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00829361
Lead sponsor
Mayo Clinic
Collaborators
Arizona Department of Health Services
Responsible party
Sponsor
First posted
Jan 27, 2009
Start date
Oct 2008
Primary completion
Oct 2011
Completion
Jan 2012
Last update
Nov 25, 2015

Study contacts

Bart M. Demerschalk, M.D.
principal investigator · Mayo Clinic
Bentley J. Bobrow, M.D.
principal investigator · Mayo Clinic
Dwight D Channer, MS
study director · Mayo Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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