Translation of the Sydney Swallow Questionnaire and Valid... | NCT01965964

Studies
Translation of the Sydney Swallow Questionnaire and Validation of the German Version

NCT01965964

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Dec 15, 2015Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Dysphagia

Interventions

Questionnaire

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Oct 15, 2013

First Submission Date that Met QC Criteria

Oct 17, 2013

First Posted Date

Oct 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2015

Last Update Posted Date

Dec 15, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Translation of a validated questionnaire (SSQ) from english to german and validation of the german version. The SSQ consists of 17 well-structured questions for the assessment and quantification of patient reported difficulties in swallowing function. The tool is specifically designed to evaluate important aspects of swallowing function The questions cover the symptoms related to combinations of variables like the anatomic region, type of dysfunction, and the consistency of swallowed bolus.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients able to understand and fill out the german translation of the questionnaire	Establishment of a questionnaire in german to determine patients' swallowing functions.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria: - patients with diagnosed dysphagia "of any causes"

sufficient proficiency in german
voluntary participation

Exclusion criteria: - insufficient knowledge of the german language

cognitive limitations
reduced general state of health

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients suffering from Dysphagia for at least half a year

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joerg E Bohlender, MD	University Hospital Zurich, Division of Otorhinolaryngology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Division of Otorhinolaryngology		Zurich	Canton of Zurich	8091	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D003680	Deglutition Disorders

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided