Deglutition DisordersNCT03816098
The Accuracy of Swallowing Disturbance Questionnaire in Screening Inpatient Elderly
An observational study of Deglutition Disorders, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
Trial summary
The aim of this research was to examine the accuracy of translated Chinese version of Swallowing Dysphagia Questionnaire and to evaluate the prevalence of dysphagia and its clinical manifestation in patients over 65 years old. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Deglutition Disorders
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2019to 31 Dec 2019
- Phase
- Observational
- 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
- No healthy volunteers
- Older adult
Study population: 40 elderly inpatients age over 65 are included in this study.
Who may be able to join
- (1) age over 65 years old; (2) does not use enteral tube feeding; (3) no serious mental or cognitive conditions; no aphasia
Who cannot join
- (1) age under 65; (2) use enteral tube feeding; (3) subjects with serious mental or cognitive conditions or aphasia (4) Allergy to barium sulfate suspension
About this study
Official title: The Accuracy of Chinese Version of Swallowing Disturbance Questionnaire in Screening Inpatient Elderly
The aim of this research was to examine the accuracy of translated Chinese version of Swallowing Dysphagia Questionnaire and to evaluate the prevalence of dysphagia and its clinical manifestation in patients over 65 years old.
- Conditions
- Deglutition Disorders
- Keywords
- elderly, screening
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| elderly patients with dysphagia | Not described | |
| elderly patients without dysphagia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing Disturbance Questionnaire
Chinese version of Swallowing Dysphagia Questionnaire consists of 15 questions regarding oral and pharyngeal stage of dysphagia. Subjects are asked to fill out the questionnaire concerning current state and during the past year using a 4-point scale.
Measured: At the baseline
Videofluroscopy Swallowing Study (VFSS)
VFSS studies are conducted using 4 different consistencies: thin liquid, nectar-thick liquid, puree, and cookie. Subjects are asked to take 2 trials for each consistency to assess if any oral or pharyngeal dysphagia occurs.
Measured: At the baseline
Secondary outcomes (2)
Clinical water test
Each subject takes 3 trials of 3cc-water using a dropper. Then sequential water drinking is assessed (about 60-70 ml). We assess: coughing, choking, voice changes. At least one symptom means dysphagia.
Measured: At the baseline
Mini-Mental State Examination (MMSE)
Mini-Mental State Examination was used to identify subjects' cognitive state.The following four cut-off levels should be employed to classify the severity of cognitive impairment: no cognitive impairment=24-30; mild cognitive impairment=19-23; moderate cognitive impairment=10-18; and severe cognitive impairment<9.
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 posted25 Jan 2019
- Study start11 Feb 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-chan, Lai, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816098
- Sponsor's protocol ID
- 07-XD-080
- Status last verified
- Jan 2019
- First submitted
- 21 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Chinese Version of Swallowing Disturbance Questionnaire in Screening Inpatient Elderly
- ClinicalTrials.gov ID
- NCT03816098
- Acronym / sponsor ID
- 07-XD-080
- Conditions
- Deglutition Disorders
- Keywords
- elderly, screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 11 Feb 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 25 Jan 2019 (actual)
- 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 examine the accuracy of translated Chinese version of Swallowing Dysphagia Questionnaire and to evaluate the prevalence of dysphagia and its clinical manifestation in patients over 65 years old.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elderly patients with dysphagia | – | – |
| elderly patients without dysphagia | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 40 elderly inpatients age over 65 are included in this study.
Key inclusion criteria (1 listed)
- (1) age over 65 years old; (2) does not use enteral tube feeding; (3) no serious mental or cognitive conditions; no aphasia
Key exclusion criteria (1 listed)
- (1) age under 65; (2) use enteral tube feeding; (3) subjects with serious mental or cognitive conditions or aphasia (4) Allergy to barium sulfate suspension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Swallowing Disturbance Questionnaire
Time frame: At the baseline
Chinese version of Swallowing Dysphagia Questionnaire consists of 15 questions regarding oral and pharyngeal stage of dysphagia. Subjects are asked to fill out the questionnaire concerning current state and during the past year using a 4-point scale.
Videofluroscopy Swallowing Study (VFSS)
Time frame: At the baseline
VFSS studies are conducted using 4 different consistencies: thin liquid, nectar-thick liquid, puree, and cookie. Subjects are asked to take 2 trials for each consistency to assess if any oral or pharyngeal dysphagia occurs.
2 secondary outcomes
Clinical water test
Time frame: At the baseline
Mini-Mental State Examination (MMSE)
Time frame: At the baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorders, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Swallowing Disturbance Questionnaire (time frame: At the baseline). The study lists 2 primary outcomes in all. 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 25 Jan 2019.