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Validation and Clinical Application of Dysphagia Screening Questionnaire

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ClinicalTrials.gov Identifier: NCT02838771
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : September 9, 2016
Sponsor:
Collaborator:
Klaipėda University
Information provided by (Responsible Party):
Nora Siupsinskiene, 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.

Condition or disease Intervention/treatment Phase
Dysphagia Swallowing Disorders Other: Water drinking test Other: Dysphagia screening questionnaire Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 293 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Validation and Clinical Application of Dysphagia Screening Questionnaire
Study Start Date : March 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. Dysphagia screening questionnaire [ Time Frame: 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 :
  1. Clinical water drinking test [ Time Frame: 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.

  2. Barthel index [ Time Frame: 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.

  3. Nutrition questionnaire [ Time Frame: 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.

  4. M. D. Anderson dysphagia inventory (MDADI) [ Time Frame: 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.

  5. The 12-Item Short Form Health Survey (SF-12 questionnaire) [ Time Frame: 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838771


Locations
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Lithuania
Lithuanian University of Health Sciences
Kaunas, Lithuania
Sponsors and Collaborators
Lithuanian University of Health Sciences
Klaipėda University
Investigators
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Principal Investigator: Nora Siupsinskiene, Professor Lithuanian University of Health Sciences Otorhinolaryngology department
Principal Investigator: Nora Siupsinskiene, Professor Klaipėda University

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Responsible Party: Nora Siupsinskiene, Professor medical doctor of otorhinolaryngology, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT02838771     History of Changes
Other Study ID Numbers: DSQ1
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: December 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nora Siupsinskiene, Lithuanian University of Health Sciences:
Swallowing Disorder
Dysphagia
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases