Real-Time Internet Evaluation of Swallowing

This study has been completed.
Sponsor:
Collaborators:
University of Illinois at Chicago
University of Wisconsin, Madison
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00580138
First received: December 20, 2007
Last updated: May 6, 2010
Last verified: May 2010
  Purpose

The purpose of this study is to determine whether real-time internet evaluations of swallowing, or x-ray swallow studies viewed over closed internet circuit, are a reliable method of evaluating swallowing function.


Condition
Stroke and/or Head and Neck Cancer.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Real-Time Internet Evaluation of Oropharyngeal Dysphagia

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Reliability Ratings Among Clinicians Using Real-time Internet Evaluation of Swallowing. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Percentages were calculated for agreement between ratings made by on site clinician and clinician off site with telemedicine.


Enrollment: 30
Study Start Date: May 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stroke or Head & Neck Cancer
Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.

Detailed Description:

The objective of this proposal is to establish the validity of an Internet based protocol for real-time, remote, telefluoroscopic evaluation of oropharyngeal swallowing function. The investigators will achieve this goal by testing the hypothesis that oropharyngeal swallowing function evaluated by an experienced speech-language pathologist (SLP) using a remote, interactive, real-time, dynamic Internet telefluoroscopic procedure, which was developed in the PI's laboratory, has an acceptable level of agreement with the evaluations performed by an experienced SLP who is present in the fluoroscopy suite and using the traditional videofluoroscopic methodology. In other words, the primary aim of this investigation is to determine whether the telemedicine approach to evaluation of swallowing function is reliable relative to the traditional method by which a clinician is in direct contact with a patient for a pre-examination interview, clinical examination, and videofluoroscopic evaluation of swallowing function. Confirmation of the reliability of the telefluoroscopic evaluation of oropharyngeal dysphagia (hereafter referred to as dysphagia) can result in equity of access for underserved groups for whom SLPs with expertise in evaluating swallowing function are locally unavailable. Ultimately, the success of this project could translate specialty services into routine clinical practice across the United States and globally.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals who have suffered a stroke and/or head and neck cancer and are referred for evaluation of swallowing function.

Criteria

Inclusion Criteria:

  • Stroke, Head & neck cancer, referred for swallowing evaluation.

Exclusion Criteria:

  • No stroke or no head and neck cancer, or not referred for swallowing evaluation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580138

Locations
United States, Illinois
University of Illinois
Urbana-Champaign, Illinois, United States, 61802
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53205
Sponsors and Collaborators
University of Arkansas
University of Illinois at Chicago
University of Wisconsin, Madison
Investigators
Principal Investigator: Adrienne Perlman University of Illinois, Urbana Champaign
Principal Investigator: Gary H McCullough, Ph.D. UAMS Medical Center
  More Information

No publications provided

Responsible Party: Adrienne Perlman, University of Illinois, Urbana-Champaign
ClinicalTrials.gov Identifier: NCT00580138     History of Changes
Other Study ID Numbers: 1 R01 DC005603, 1 R01 DC005603
Study First Received: December 20, 2007
Results First Received: May 6, 2010
Last Updated: May 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Deglutition Disorders
Evaluation
Real-time internet

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014