- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01138592
Pilot Study to Evaluate the Clinical Utility of Auscultation Software at Remote Locations
Pilot Study to Evaluate the Clinical Utility of 3M Littmann Scope-to-Scope Software for Real-time Assessment of Patients at Remote Clinic Locations by Centrally-located Medical Providers
Primary Objective: Evaluation of the utility of real-time, scope-to-scope communication between commercially-available 3M Littmann Electronic Model 3200 Electronic stethoscopes over a dedicated intranet system for the assessment of patients at remote (satellite) clinic locations by centrally-located (hub) medical providers.
Secondary Objective: Comparison of the accuracy of patient assessment between the remotely located, mid-level presenter with the centrally-located physician or nurse practitioner provider.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Arizona
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Flagstaff, Arizona, United States, 86004
- North Country Health Care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male and female subjects who are at least 18 years of age
- Subjects who are scheduled to undergo examination in a telemedicine setting
- Subjects who are willing to voluntarily sign the compound Informed Consent and the Authorization to Disclose Protected Health Information Form.
Exclusion Criteria:
- Subjects who are unwilling to undergo additional examination in a telemedicine setting,
- Any subject requiring time-critical medical intervention.
- Any subject who the investigator believes should not be included or is unsuitable for inclusion in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Primary Care Patients
Any patient undergoing a telemedicine evaluation involving auscultation of the heart and lungs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmation of hub (remote) observations with satellite (local) observations
Time Frame: 30 minutes
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Presence or absence of heart or lung sound; e.g., murmurs, etc., and/or rales, rhonchii, wheezes.
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30 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eric Henley, MD, MPH, North Country Health Care, Flagstaff, AZ
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 05-003041
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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