NCT02838771

Brief Summary

The aim of this research was to develop a dysphagia screening measure and evaluate the prevalence of dysphagia and its clinical manifestation in different in age population groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
293

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
Last Updated

September 9, 2016

Status Verified

December 1, 2013

Enrollment Period

1.8 years

First QC Date

July 18, 2016

Last Update Submit

September 7, 2016

Conditions

DysphagiaSwallowing Disorders

Keywords

Swallowing DisorderDysphagia

Outcome Measures

Primary Outcomes (1)

  • Dysphagia screening questionnaire

    Lithuanian version of questionnaire consists of 16 questions about masticatory and swallowing functions and dysphagia consequences during patients last one year.

    At the baseline

Secondary Outcomes (5)

  • Clinical water drinking test

    At the baseline

  • Barthel index

    At the baseline

  • Nutrition questionnaire

    At the baseline

  • M. D. Anderson dysphagia inventory (MDADI)

    At the baseline

  • The 12-Item Short Form Health Survey (SF-12 questionnaire)

    At the baseline

Study Arms (2)

Research group participants

EXPERIMENTAL

Research group consisted of 171 elderly nursing home residents and 82 outpatients of the Hospital of Lithuanian University of Health Sciences. The participants were given the dysphagia screening questionnaire, consisted of 16 questions and the several sips of water to drink (clinical water drinking test for dysphagia screening).

Other: Water drinking testOther: Dysphagia screening questionnaire

Control group participants

OTHER

Community-dwelling elderly healthy individuals. The participants were given the dysphagia screening questionnaire, consisted of 16 questions and the several sips of water to drink (clinical water drinking test for dysphagia screening).

Other: Water drinking testOther: Dysphagia screening questionnaire

Interventions

Water drinking testOTHER

Patient takes a sip of water about 60-70 ml. We assess: coughing, choking, voice changes.

Control group participantsResearch group participants
Dysphagia screening questionnaireOTHER

Lithuanian version of the questionnaire consists of 16 questions. Interpretation of dysphagia screening questionnaire: advanced symptom - 2 points, moderate intensity symptom - 1 point, no symptom - 0 point. At least one advanced symptom means - dysphagia. Higher score represents stronger dysphagia intensity. The maximum score is 32 points.

Control group participantsResearch group participants

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Adults
  • Consent for participating in the research
  • No cognitive disorders or mental illnesses

You may not qualify if:

  • Refusal to participate in the research
  • Serious mental or cognitive conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Nora Siupsinskiene, Professor

    Lithuanian University of Health Sciences Otorhinolaryngology department

    PRINCIPAL INVESTIGATOR

  • Nora Siupsinskiene, Professor

    Klaipėda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor medical doctor of otorhinolaryngology

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 20, 2016

Study Start

March 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

September 9, 2016

Record last verified: 2013-12

Locations

LI(1)