Head and Neck CancerNCT00580138
Real-Time Internet Evaluation of Swallowing
An observational study of Head and Neck Cancer and Stroke, run by University of Arkansas at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Head and Neck Cancer, Stroke
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2005to Mar 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who have suffered a stroke and/or head and neck cancer and are referred for evaluation of swallowing function.
Who may be able to join
- Stroke, Head \& neck cancer, referred for swallowing evaluation.
Who cannot join
- No stroke or no head and neck cancer, or not referred for swallowing evaluation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin
Madison, Wisconsin, 53205
University of Illinois
Urbana-Champaign, Illinois, 61802
About this study
Official title: Real-Time Internet Evaluation of Oropharyngeal Dysphagia
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.
Read the 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.
- Conditions
- Head and Neck Cancer, Stroke
- Keywords
- Deglutition Disorders, Evaluation, Real-time internet
- Medical subject headings
- Head and Neck Neoplasms, Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startMay 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrienne Perlman, Principal investigator, University of Illinois, Urbana ChampaignGary H McCullough, Ph.D., Principal investigator, UAMS Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580138
- Sponsor's protocol ID
- 1R01DC005603
- Other IDs
- 1R01DC005603
- Status last verified
- Jan 2017
- First submitted
- 20 Dec 2007
- Last updated
- 20 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Internet Evaluation of Oropharyngeal Dysphagia
- ClinicalTrials.gov ID
- NCT00580138
- Acronym / sponsor ID
- 1R01DC005603
- Conditions
- Head and Neck Cancer, Stroke
- Keywords
- Deglutition Disorders, Evaluation, Real-time internet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, University of Wisconsin, Madison
- Study start
- May 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Posted 7 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have suffered a stroke and/or head and neck cancer and are referred for evaluation of swallowing function.
Key inclusion criteria (1 listed)
- Stroke, Head \& neck cancer, referred for swallowing evaluation.
Key exclusion criteria (1 listed)
- No stroke or no head and neck cancer, or not referred for swallowing evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability Ratings Among Clinicians Using Real-time Internet Evaluation of Swallowing.
Time frame: 2 years
Percentages were calculated for agreement between ratings made by on site clinician and clinician off site with telemedicine.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrienne Perlman principal investigator
University of Illinois, Urbana Champaign
Gary H McCullough, Ph.D. principal investigator
UAMS Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Stroke, run by University of Arkansas at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability Ratings Among Clinicians Using Real-time Internet Evaluation of Swallowing. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2017.