Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000989640
Ethics application status
Approved
Date submitted
25/08/2023
Date registered
11/09/2023
Date last updated
18/08/2024
Date data sharing statement initially provided
11/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
My Liver Health App for Ascites
Scientific title
Feasibility of a digital health intervention for the management of ascites in patients with chronic liver disease
Secondary ID [1] 310472 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ascites 331263 0
Chronic liver disease 331351 0
Condition category
Condition code
Oral and Gastrointestinal 328017 328017 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Using a smartphone application, and scales, to better manage ascites/liver disease. Upon consent, participants will have an orientation visit in hospital (approximately 30mins) where they will be set up with their WiFi enabled scales and the smartphone application. Participants are required to weigh themselves daily for the duration of the study (6mths) and answer 4 questions regarding their health and medication adherence (max 10mins). Each week they will be asked 2 additional questions regarding their overall health (5mins). Participants will have their standard of care follow-up in clinic as needed. Participants weight will be monitored daily by the study team (hepatologist and chronic liver disease nurses) with interventions (phone call, bloods, paracentesis) made should an alert appear. Alerts will be triggered if a participant gains more than 3kgs over 3 days or gains more than 5kgs over 1 week, with additional alerts to be turned on depending if a participant has oedema or not.



Intervention code [1] 326863 0
Treatment: Other
Comparator / control treatment
Historical paracentesis and nurse contact data for each participant enrolled (up to 6mths prior to the intervention baseline) collected from medical records
Control group
Active

Outcomes
Primary outcome [1] 335886 0
The percentage of days with weight data transmitted successfully to care team as assessed by the app analytics
Timepoint [1] 335886 0
End of study (6mths for each participant)
Primary outcome [2] 335887 0
The number of weight alerts determined by the flags on the clinician dashboard that prompted responses from the care team (as determined by the medical records)
Timepoint [2] 335887 0
End of study (6mths for each participant)
Primary outcome [3] 335888 0
The primary outcome measure of the qualitative review is to evaluate the benefits and barriers to the intervention (Composite outcome), as assessed by a 10 minute open-ended face-to-face interview at the end of the study
Timepoint [3] 335888 0
End of study (6mths for each participant)
Secondary outcome [1] 425992 0
The percentage of patients that required diuretic dose modification as determined from medical records
Timepoint [1] 425992 0
End of study (6mths for each participant)
Secondary outcome [2] 425993 0
The percentage of patients that required admission for large volume paracentesis/ascites as determined from medical records
Timepoint [2] 425993 0
End of study (6mths for each participant)
Secondary outcome [3] 425994 0
Number of liver related emergency admissions as determined from medical records
Timepoint [3] 425994 0
End of study (6mths for each participant)
Secondary outcome [4] 425995 0
The number of contacts with care team independent of triggers from the app as determined from medical records
Timepoint [4] 425995 0
End of study (6mths for each participant)
Secondary outcome [5] 425996 0
Analyse patient satisfaction with the smartphone application as determined from a study-specific survey
Timepoint [5] 425996 0
End of study (6mths for each participant)
Secondary outcome [6] 425997 0
Analyse care teams experience in regard to usability of the dashboard as determined from a study-specific survey
Timepoint [6] 425997 0
End of study
Secondary outcome [7] 425998 0
Evaluate the desired features of the ascites management app as assessed by a 10 minute open-ended face-to-face interview at the end of the study
Timepoint [7] 425998 0
End of study

Eligibility
Key inclusion criteria
Age greater than or equal to 18 years
Ability to provide informed consent
Patients with cirrhotic ascites requiring active management
Patient owns an android or iOS compatible smartphone
Patient is able to use a smartphone device at a basic level
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient with severe cognitive impairment
Patients with insufficient command of the English language to be able to understand the instructions
Patients who do not have, or are unable to use, a smartphone device
Patients under active management by Palliative care services or an expected survival of <3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/11/2022
Date of last participant enrolment
Anticipated
1/02/2024
Actual
5/01/2024
Date of last data collection
Anticipated
2/08/2024
Actual
5/07/2024
Sample size
Target
30
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25451 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 41201 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 314675 0
Charities/Societies/Foundations
Name [1] 314675 0
Flinders Foundation Health Seed grant
Country [1] 314675 0
Australia
Primary sponsor type
Government body
Name
Southern Adelaide Local Health Network
Address
Flinders Medical CentreFlinders Drive, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 316643 0
None
Name [1] 316643 0
Address [1] 316643 0
Country [1] 316643 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313694 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 313694 0
Ethics committee country [1] 313694 0
Australia
Date submitted for ethics approval [1] 313694 0
26/11/2021
Approval date [1] 313694 0
16/02/2022
Ethics approval number [1] 313694 0
2021/HRE00336

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

Contacts
Principal investigator
Name 129042 0
Prof Alan Wigg
Address 129042 0
Lvl 3, Department of Gastroenterology and Hepatology
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Country 129042 0
Australia
Phone 129042 0
+61 8 82043941
Fax 129042 0
Email 129042 0
[email protected]
Contact person for public queries
Name 129043 0
Sumudu Narayana
Address 129043 0
Lvl 3, Department of Gastroenterology and Hepatology
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Country 129043 0
Australia
Phone 129043 0
+61 8 8204 5839
Fax 129043 0
Email 129043 0
[email protected]
Contact person for scientific queries
Name 129044 0
Alan Wigg
Address 129044 0
Lvl 3, Department of Gastroenterology and Hepatology
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Country 129044 0
Australia
Phone 129044 0
+61 8 82043941
Fax 129044 0
Email 129044 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data for this trial will analysed as a group to determine whether the smartphone application benefits the patient population rather than individually. As per ethics approval, IPD will not be made available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20138Study protocol    386496-(Uploaded-25-08-2023-15-11-19)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.