Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04344964




Registration number
NCT04344964
Ethics application status
Date submitted
10/04/2020
Date registered
14/04/2020

Titles & IDs
Public title
Endoscopy-related Phone Consultation During the COVID-19 Outbreak
Scientific title
Endoscopy-related Phone Consultation During the COVID-19 Outbreak: Impact on Attendance and Patient/Consultant Perspectives From a Tertiary Australian Hospital
Secondary ID [1] 0 0
38839
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon Polyp 0 0
Colon Disease 0 0
Reflux, Gastroesophageal 0 0
Varices, Esophageal 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - None - NA

Phone consult group - Information collected prospectively on FTA patients and questionnaire (satisfaction)

Face-to-face consult group - Information collected retrospectively on FTA patients


Other interventions: None - NA
Observational study
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Failed to attend patients
Timepoint [1] 0 0
2 months
Secondary outcome [1] 0 0
Patient satisfaction with the phone consult
Timepoint [1] 0 0
2 months
Secondary outcome [2] 0 0
Consultant satisfaction with the phone consult
Timepoint [2] 0 0
2 months

Eligibility
Key inclusion criteria
* Patients booked for an outpatient consultation in the Post-Endoscopy clinic or Advanced Endoscopy clinic
* Consultation determined to be held over the phone as per preventive measures due to the COVID-19 outbreak
* Age > 18 years
* Ability to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Phone consultation done with a relative as per patient's preference or inability to talk over the phone
* Patient that is deemed as confused/not able to understand
* Unwilling/unable to participate in the post-consultation survey

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/04/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/07/2020
Sample size
Target
Accrual to date
Final
186
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sujievvan Chandran, MD
Address 0 0
Consultant Gastroenterologist
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For ethical purposes as per the approval of this study as a quality improvement study (and hence exempted of formal HREC evaluation). Data should be shared outside Austin Health only through grouped data in conferences and journal papers.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04344964