DysphagiaNCT02838771
Validation and Clinical Application of Dysphagia Screening Questionnaire
A study testing Water drinking test and Dysphagia screening questionnaire in people with Dysphagia and Swallowing Disorders, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Swallowing Disorders
- What is being tested?
- Water drinking test and Dysphagia screening questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteLithuania
- Study dates
- Mar 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults
- Consent for participating in the research
- No cognitive disorders or mental illnesses
Who cannot join
- Refusal to participate in the research
- Serious mental or cognitive conditions
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dysphagia, Swallowing Disorders
- Being tested
- Water drinking test, Dysphagia screening questionnaire
- Keywords
- Swallowing Disorder, Dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water drinking testOther
Patient takes a sip of water about 60-70 ml. We assess: coughing, choking, voice changes.
Dysphagia screening questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Research group participants | Experimental | 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). Receives: Other: Water drinking test; Other: Dysphagia screening questionnaire |
| Control group participants | Other | 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). Receives: Other: Water drinking test; Other: Dysphagia screening questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia screening questionnaire
Lithuanian version of questionnaire consists of 16 questions about masticatory and swallowing functions and dysphagia consequences during patients last one year.
Measured: At the baseline
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startMar 2011
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Klaipėda University
- Responsible party
- Principal investigator, Nora Siupsinskiene, Lithuanian University of Health Sciences
- Investigators
- Nora Siupsinskiene, Professor, Principal investigator, Lithuanian University of Health Sciences Otorhinolaryngology departmentNora Siupsinskiene, Professor, Principal investigator, Klaipėda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838771
- Sponsor's protocol ID
- DSQ1
- Status last verified
- Dec 2013
- First submitted
- 18 Jul 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Clinical Application of Dysphagia Screening Questionnaire
- ClinicalTrials.gov ID
- NCT02838771
- Acronym / sponsor ID
- DSQ1
- Conditions
- Dysphagia, Swallowing Disorders
- Keywords
- Swallowing Disorder, Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Klaipėda University
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research group participants | Experimental | Other: Water drinking test, Other: Dysphagia screening questionnaireResearch 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 | Other | Other: Water drinking test, Other: Dysphagia screening questionnaireCommunity-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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Adults
- Consent for participating in the research
- No cognitive disorders or mental illnesses
Key exclusion criteria (2 listed)
- Refusal to participate in the research
- Serious mental or cognitive conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water drinking testPatient takes a sip of water about 60-70 ml. We assess: coughing, choking, voice changes. | Other | Control group participants, Research group participants |
| Dysphagia screening questionnaireLithuanian 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, Research group participants |
Primary outcome
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.
5 secondary outcomes
Clinical water drinking test
Time frame: At the baseline
Barthel index
Time frame: At the baseline
Nutrition questionnaire
Time frame: At the baseline
M. D. Anderson dysphagia inventory (MDADI)
Time frame: At the baseline
The 12-Item Short Form Health Survey (SF-12 questionnaire)
Time frame: At the baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora Siupsinskiene, Professor principal investigator
Lithuanian University of Health Sciences Otorhinolaryngology department
Nora Siupsinskiene, Professor principal investigator
Klaipėda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water drinking test and Dysphagia screening questionnaire in people with Dysphagia and Swallowing Disorders, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia screening questionnaire (time frame: At the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.