Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)

Sponsor

Cambridge University Hospitals NHS Foundation Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT04584658

Collaborator

(none)

Enrollment

Location

14.5

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study examines the presence, severity and natural history of dysphagia and dysphonia in the post-extubation and severely unwell COVID-19 patient.

Condition or Disease	Intervention/Treatment	Phase
Dysphagia Dysphonia Subglottic Stenosis Voice Disorders Swallowing Disorder Covid19 SARS (Severe Acute Respiratory Syndrome) SARS Pneumonia Quality of Life SARS-CoV-2 Infection	Diagnostic Test: Fibreoptic Endoscopic Evaluation of Swallowing (FEES) Diagnostic Test: Videofluoroscopy Other: Dysphagia Handicap Index (DHI) Other: Voice Symptom Scale (VoiSS)

Study Design

Study Type:

Observational

Anticipated Enrollment :

36 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19): A Prospective Observational Cohort Study.

Actual Study Start Date :

Sep 15, 2020

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Outcome Measures

Primary Outcome Measures

Primary endpoint is severity of dysphonia and dysphagia at the time of initial assessment t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation). [t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).]
Based on therapy outcome measures from FEES, VoiS

Secondary Outcome Measures

The severity of dysphonia and/or dysphagia over an initial 12 month period (at t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months) [t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months]
Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
The severity of dysphonia and/or dysphagia at t = day 5, day 10, day 14, day 21 - For in-patients only. [t = day 5, day 10, day 14, day 21 - For in-patients only.]
Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Relationship between severity of dysphonia and/or dysphagia with grade of ARDS [t = day 0 and 9 months]
Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Relationship between severity of dysphonia and/or dysphagia with length of intubation [t = day 0 and 9 months]
Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Relationship between severity of dysphonia and/or dysphagia with duration of mechanical ventilation [t = day 0 and 9 months]
Clinical assessment including outcome measures, FEES and/or Videofluoroscopy
Relationship between severity of dysphonia on quality of life using Voice Symptom Scale (VoiSS) questionnaire over time at day 0, 1 month and 9 months. [t = day 0, 1 month and 9 months.]
Questionnaire assessment: This is a 30-item validated quality of life tool that is also a self-reporting tool. It appraises the impact of the patient's abnormal voice from an emotional perspective, related physical symptoms and stratifies the impairment itself in context of day to day activities. VoiSS is currently the most psychometrically robust voice outcome measure. Each item is scored 0 - 4 on the frequency responses: never, occasionally, some of the time, most of the time, always. The total score of 120 measures general voice pathology which is made up of Impairment = maximum score of 60; Emotional = maximum score of 32; Physical = maximum score of 28
Relationship between severity of dysphagia on quality of life using Dysphagia Handicap Index (DHI) questionnaire over time at day 0, 1 month and 9 months [t = day 0, 1 month and 9 months]
Questionnaire assessment: This is a 25-item questionnaire assessing three domains: physical (9 items), functional (9 items), and emotional aspects (7 items) of the Quality of Life (QOL) in patients suffering with dysphagia. For each statement the patient checks if it applies to him/her all the time, some of the time or never. The suggested scores are 0, 2 and 4, respectively. Using this scoring system amounts to a DHI score range of 0 - 100. The higher the score, the worse the dysphagia related QOL. The patient is also asked to provide a rating of their own impression of the severity of the dysphagia experienced on a scale from 1 (normal) to 7 (severe problem).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients who have been diagnosed with a positive SARS CoV-2 test.
Patients who have been diagnosed with dysphonia and/or dysphagia following COVID 19 treatment.
Patients who require investigation and management for dysphonia and/or dysphagia following COVID 19 treatment.
Adult patients aged 18 years - 85 years.
Patients that meet threshold for referral to the joint MDT clinic following screening

Exclusion Criteria:

Patients who cannot undertake the assessment for dysphonia and/or dysphagia.
Patients who are being managed with palliative intent.
Patients with pre-existing dysphonia and/or dysphagia not previously responding to therapy (pre-existing prior to COVID-19 diagnosis).