NCT03816098

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

January 21, 2019

Last Update Submit

January 21, 2019

Conditions

Deglutition Disorders

Keywords

elderlyscreening

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    At the baseline

Secondary Outcomes (2)

  • Clinical water test

    At the baseline

  • Mini-Mental State Examination (MMSE)

    At the baseline

Study Arms (2)

elderly patients with dysphagia

elderly patients without dysphagia

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

40 elderly inpatients age over 65 are included in this study.

You may qualify if:

  • (1) age over 65 years old; (2) does not use enteral tube feeding; (3) no serious mental or cognitive conditions; no aphasia

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Speech-language therapist

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 25, 2019

Study Start

February 11, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 25, 2019

Record last verified: 2019-01