Stroke Team Remote Evaluation Using a Digital Observation Camera- Long Term Outcomes(STRokE DOC-LTO)

NCT ID: NCT00936455

Last Updated: 2012-04-30

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-08-31

Brief Summary

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SPECIFIC AIM: The specific aims of this study are to evaluate the long term outcomes of patients previously enrolled in the STRokE DOC ("STRokE DOC Trial (NCT00283868)") telemedicine clinical trial.

AIM 1: Aim 1 is a non- randomized, retrospective, data collection study assessing long term patient outcomes of patients previously enrolled in a telemedicine vs. telephone clinical trial (STRokE DOC Trial ("STRokE DOC Trial (NCT00283868)"); now completed). STRokE DOC-LTO will evaluate, (only for those patients previously enrolled in the original telemedicine vs. telephone clinical research trial), the long term patient outcomes; comparing telemedicine versus telephone-only consultations.

Detailed Description

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SPECIFIC AIM: The specific aims of this study are to evaluate the long term outcomes of patients previously enrolled in the STRokE DOC ("STRokE DOC Trial (NCT00283868)") telemedicine clinical trial.

AIM 1: Aim 1 is a non- randomized, retrospective, data collection study assessing long term patient outcomes of patients previously enrolled in a telemedicine vs. telephone clinical trial (STRokE DOC Trial ("STRokE DOC Trial (NCT00283868)"); now completed). STRokE DOC-LTO will evaluate, (only for those patients previously enrolled in the original telemedicine vs. telephone clinical research trial), the long term patient outcomes; comparing telemedicine versus telephone-only consultations.

Specific Protocol Information: The protocol will contact these patients by telephone. One of 5 Stroke Center team members will contact the patient, using strict telephone scripted language (approved by the IRB) and ask questions regarding

1. current functional status
2. death
3. Hemorrhage
4. Recurrent Stroke
5. Disposition for 3 time periods (6 months after index event, 12 months after index event, and "current" time of contact.

Conditions

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Telemedicine Evaluation vs Telephone Evaluation

Keywords

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telemedicine telephone outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Telemedicine

Telemedicine evaluated patients

No interventions assigned to this group

Telephone

Telephone evaluated patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects, age \> 18 years.
2. Prior enrollment into the STRokE DOC ("STRokE DOC Trial (NCT00283868)") clinical research trial.

Exclusion Criteria

1. Male or female subjects, age \< 18 years.
2. Patients not previously enrolled into the STRokE DOC ("STRokE DOC Trial (NCT00283868)") clinical research trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Brett Meyer

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brett C Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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UCSD

San Diego, California, United States

Site Status

Countries

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United States

References

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Meyer BC, Raman R, Hemmen T, Obler R, Zivin JA, Rao R, Thomas RG, Lyden PD. Efficacy of site-independent telemedicine in the STRokE DOC trial: a randomised, blinded, prospective study. Lancet Neurol. 2008 Sep;7(9):787-95. doi: 10.1016/S1474-4422(08)70171-6.

Reference Type BACKGROUND
PMID: 18676180 (View on PubMed)

Meyer BC, Raman R, Ernstrom K, Tafreshi GM, Huisa B, Stemer AB, Hemmen TM. Assessment of long-term outcomes for the STRokE DOC telemedicine trial. J Stroke Cerebrovasc Dis. 2012 May;21(4):259-64. doi: 10.1016/j.jstrokecerebrovasdis.2010.08.004. Epub 2010 Sep 19.

Reference Type DERIVED
PMID: 20851629 (View on PubMed)

Other Identifiers

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STRokE DOC-LTO

Identifier Type: -

Identifier Source: org_study_id