NCT00580138

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 7, 2010

Completed
Last Updated

February 20, 2017

Status Verified

January 1, 2017

Enrollment Period

3.8 years

First QC Date

December 20, 2007

Results QC Date

May 6, 2010

Last Update Submit

January 4, 2017

Conditions

Keywords

Deglutition DisordersEvaluationReal-time internet

Outcome Measures

Primary Outcomes (1)

  • Reliability Ratings Among Clinicians Using Real-time Internet Evaluation of Swallowing.

    Percentages were calculated for agreement between ratings made by on site clinician and clinician off site with telemedicine.

    2 years

Study Arms (1)

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.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • No stroke or no head and neck cancer, or not referred for swallowing evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois

Urbana-Champaign, Illinois, 61802, United States

Location

University of Wisconsin

Madison, Wisconsin, 53205, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsStrokeDeglutition Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
Gary McCullough
Organization
University of Arkansas for Medical Sciences Medical Center

Study Officials

  • Adrienne Perlman

    University of Illinois, Urbana Champaign

    PRINCIPAL INVESTIGATOR
  • Gary H McCullough, Ph.D.

    UAMS Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 24, 2007

Study Start

May 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 20, 2017

Results First Posted

June 7, 2010

Record last verified: 2017-01

Locations