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Validation and Clinical Application of Dysphagia Screening Questionnaire

Primary Purpose

Dysphagia, Swallowing Disorders

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Water drinking test
Dysphagia screening questionnaire
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dysphagia focused on measuring Swallowing Disorder, Dysphagia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Lithuanian University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Research group participants

Control group participants

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical water drinking test
A subject takes one tablespoon of water. Then - a sip of water (about 60-70 ml). We assess: coughing, choking, voice changes. At least one symptom means dysphagia.
Barthel index
Barthel index was used to identify objectively the functional state. According to Barthel index 100 points mean - functional independency, 91 - 99 - little dependency, 61 - 90 - moderate dependency, 21 - 60 - almost total dependency, 0 - 20 - total dependency.
Nutrition questionnaire
Nutrition questionnaire was used to identify objectively the nutritional state. The maximal score of nutritional state questionnaire - 30. 24 or more points mean - good nutritional state, 17-23,5 - risk of insufficient nutrition, < 17 - insufficient nutrition.
M. D. Anderson dysphagia inventory (MDADI)
Assessment if dysphagia effects the quality of life. Questionnaire consists of 20 questions. The emotional, functional, physical and global subscales are measured. Scores of each item can be from 0 to 100, they are summed, a mean score is calculated. A higher MDADI score represents better functioning and better quality of life.
The 12-Item Short Form Health Survey (SF-12 questionnaire)
Assessment of the quality of life, general health status using 12 questions. Assess physical functioning, role limitation due to physical problems, bodily pain, general health, vitality, social functioning, limitations in usual role activities because of emotional problems, mental health. Scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Full Information

First Posted
July 18, 2016
Last Updated
September 7, 2016
Sponsor
Lithuanian University of Health Sciences
Collaborators
Klaipėda University
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1. Study Identification

Unique Protocol Identification Number
NCT02838771
Brief Title
Validation and Clinical Application of Dysphagia Screening Questionnaire
Official Title
Validation and Clinical Application of Dysphagia Screening Questionnaire
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences
Collaborators
Klaipėda University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The dysphagia screening questionnaire had the stages of validation - translation and back translation, a review of the translation and back translation committee, pre-test study (36 persons) with monolingual individuals and the test re-test study (67 subjects included). The case - control study groups were tested using dysphagia screening questionnaire and clinical screening - water drinking test. Barthel index and nutrition questionnaire were used to identify the nutritional and functional state. M. D. Anderson dysphagia inventory questionnaire, sf-12 questionnaire were used to assess dysphagia effects on the quality of life. The research group consisted of two subgroups - 171 nursing home residents from 3 different nursing homes and 82 outpatients of the Hospital of Lithuanian University of Health Sciences. The control group consisted of randomly selected 40 community-dwelling elderly healthy individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Swallowing Disorders
Keywords
Swallowing Disorder, Dysphagia

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Research group participants
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group participants
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Water drinking test
Intervention Description
Patient takes a sip of water about 60-70 ml. We assess: coughing, choking, voice changes.
Intervention Type
Other
Intervention Name(s)
Dysphagia screening questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dysphagia screening questionnaire
Description
Lithuanian version of questionnaire consists of 16 questions about masticatory and swallowing functions and dysphagia consequences during patients last one year.
Time Frame
At the baseline
Secondary Outcome Measure Information:
Title
Clinical water drinking test
Description
A subject takes one tablespoon of water. Then - a sip of water (about 60-70 ml). We assess: coughing, choking, voice changes. At least one symptom means dysphagia.
Time Frame
At the baseline
Title
Barthel index
Description
Barthel index was used to identify objectively the functional state. According to Barthel index 100 points mean - functional independency, 91 - 99 - little dependency, 61 - 90 - moderate dependency, 21 - 60 - almost total dependency, 0 - 20 - total dependency.
Time Frame
At the baseline
Title
Nutrition questionnaire
Description
Nutrition questionnaire was used to identify objectively the nutritional state. The maximal score of nutritional state questionnaire - 30. 24 or more points mean - good nutritional state, 17-23,5 - risk of insufficient nutrition, < 17 - insufficient nutrition.
Time Frame
At the baseline
Title
M. D. Anderson dysphagia inventory (MDADI)
Description
Assessment if dysphagia effects the quality of life. Questionnaire consists of 20 questions. The emotional, functional, physical and global subscales are measured. Scores of each item can be from 0 to 100, they are summed, a mean score is calculated. A higher MDADI score represents better functioning and better quality of life.
Time Frame
At the baseline
Title
The 12-Item Short Form Health Survey (SF-12 questionnaire)
Description
Assessment of the quality of life, general health status using 12 questions. Assess physical functioning, role limitation due to physical problems, bodily pain, general health, vitality, social functioning, limitations in usual role activities because of emotional problems, mental health. Scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time Frame
At the baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults Consent for participating in the research No cognitive disorders or mental illnesses Exclusion Criteria: Refusal to participate in the research Serious mental or cognitive conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nora Siupsinskiene, Professor
Organizational Affiliation
Lithuanian University of Health Sciences Otorhinolaryngology department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nora Siupsinskiene, Professor
Organizational Affiliation
Klaipėda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lithuanian University of Health Sciences
City
Kaunas
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Validation and Clinical Application of Dysphagia Screening Questionnaire

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