DysphagiaNCT01958268
Dysphagia Handicap Index: A Structured Translation From English to German
An observational study of Dysphagia, run by University of Zurich at 1 site in Switzerland.
Trial summary
Establishment of a questionnaire in German to determine in a structured and quantifiable manner the quality of life of patients with dysphagia. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- Pretest and validation of a translated questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from dysphagia
Inclusion criteria: All patients with dysphagia
Exclusion criteria: Inability to fill in the questionnaire
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Otorhinolaryngology
Zurich, Canton of Zurich, 8091
About this study
Official title: Dysphagia Handicap Index: A Structured Translation From English to German of a Quality of Life Questionnaire Relating to Swallowing
Establishment of a questionnaire in German to determine in a structured and quantifiable manner the quality of life of patients with dysphagia.
- Conditions
- Dysphagia
- Being tested
- Pretest and validation of a translated questionnaire
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pretest and validation of a translated questionnaireProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients able to fully understand and fill out the german translation of the questionnaire.
Establishment of a questionnaire in german to determine in a structured and quantifiable manner the quality of life of patients with dysphagia.
Measured: Patients suffering from dysphagia for at least half a year will be asked to answer the questionnaire at the time of enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joerg E Bohlender, KD Dr. med., Principal investigator, University Hospital Zurich, Division of Otorhinolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958268
- Sponsor's protocol ID
- BJ_02_08_2013
- Status last verified
- Dec 2015
- First submitted
- 19 Sep 2013
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysphagia Handicap Index: A Structured Translation From English to German of a Quality of Life Questionnaire Relating to Swallowing
- ClinicalTrials.gov ID
- NCT01958268
- Acronym / sponsor ID
- BJ_02_08_2013
- Conditions
- Dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Establishment of a questionnaire in German to determine in a structured and quantifiable manner the quality of life of patients with dysphagia.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from dysphagia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pretest and validation of a translated questionnaire | Procedure or surgery | – |
Primary outcome
Percentage of patients able to fully understand and fill out the german translation of the questionnaire.
Time frame: Patients suffering from dysphagia for at least half a year will be asked to answer the questionnaire at the time of enrolment.
Establishment of a questionnaire in german to determine in a structured and quantifiable manner the quality of life of patients with dysphagia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
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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.
Joerg E Bohlender, KD Dr. med. principal investigator
University Hospital Zurich, Division of Otorhinolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients able to fully understand and fill out the german translation of the questionnaire. (time frame: Patients suffering from dysphagia for at least half a year will be asked to answer the questionnaire at the time of enrolment.). 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 5 Jan 2016.