Pilot Study to Evaluate the Clinical Utility of Auscultation Software at Remote Locations

NCT ID: NCT01138592

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Auscultation of Heart and Lungs

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary Care Patients

Any patient undergoing a telemedicine evaluation involving auscultation of the heart and lungs.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Male and female subjects who are at least 18 years of age
2. Subjects who are scheduled to undergo examination in a telemedicine setting
3. Subjects who are willing to voluntarily sign the compound Informed Consent and the Authorization to Disclose Protected Health Information Form.

Exclusion Criteria

1. Subjects who are unwilling to undergo additional examination in a telemedicine setting,
2. Any subject requiring time-critical medical intervention.
3. Any subject who the investigator believes should not be included or is unsuitable for inclusion in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Henley, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

North Country Health Care, Flagstaff, AZ

Locations

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North Country Health Care

Flagstaff, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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05-003041

Identifier Type: -

Identifier Source: org_study_id

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