Validation and Clinical Application of Dysphagia Screening Questionnaire

Not Applicable

Completed

• Conditions: Dysphagia; Swallowing Disorders
• Interventions: Other: Water drinking test; Other: Dysphagia screening questionnaire

• Registration Number: NCT02838771
• Lead Sponsor: Lithuanian University of Health Sciences

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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-12
• Status Verified: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-20
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group participants	Dysphagia screening questionnaire	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).
Research group participants	Water drinking test	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).
Control group participants	Water drinking test	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).
Research group participants	Dysphagia screening questionnaire	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).

Primary Outcome Measures

Name	Time	Method
Dysphagia screening questionnaire	At the baseline	Lithuanian version of questionnaire consists of 16 questions about masticatory and swallowing functions and dysphagia consequences during patients last one year.

Secondary Outcome Measures

Name	Time	Method
Clinical water drinking test	At the baseline	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	At the baseline	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	At the baseline	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)	At the baseline	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)	At the baseline	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.

Trial Locations

Locations (1)

Lithuanian University of Health Sciences; 🇱🇹 Kaunas, Lithuania