Validation and Clinical Application of Dysphagia Screening Questionnaire

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.

Study Overview

• Status: Completed
• Conditions: Dysphagia; Swallowing Disorders
• Intervention / Treatment: Other: Water drinking test; Other: Dysphagia screening questionnaire

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.

• Study Type: Interventional
• Enrollment (Actual): 293
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania
    • Lithuanian University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Research group participants; 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 test; Patient takes a sip of water about 60-70 ml. We assess: coughing, choking, voice changes.; Other: Dysphagia screening questionnaire; 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.
Other: Control group participants; 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 test; Patient takes a sip of water about 60-70 ml. We assess: coughing, choking, voice changes.; Other: Dysphagia screening questionnaire; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the baseline
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.	At the baseline
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.	At the baseline
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.	At the baseline
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.	At the baseline

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Collaborators: Klaipėda University
• Investigators: Principal Investigator: Nora Siupsinskiene, Professor, Lithuanian University of Health Sciences Otorhinolaryngology department; Principal Investigator: Nora Siupsinskiene, Professor, Klaipėda university

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Estimate): September 9, 2016
• Last Update Submitted That Met QC Criteria: September 7, 2016
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Swallowing Disorder; Dysphagia
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: DSQ1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No