Validation and Clinical Application of Dysphagia Screening Questionnaire

Dysphagia Clinical Trial

Official title:

Validation and Clinical Application of Dysphagia Screening Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838771
• Other study ID #: DSQ1
• Status: Completed
• Phase: N/A
• First received: July 18, 2016
• Last updated: September 7, 2016
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Swallowing Disorders

Intervention

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

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (2)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	Klaipeda University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No