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Trial registered on ANZCTR


Registration number
ACTRN12617000340336
Ethics application status
Approved
Date submitted
28/02/2017
Date registered
3/03/2017
Date last updated
8/03/2021
Date data sharing statement initially provided
8/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A new e-health model of care for management of chronic disease: determining safety, efficacy and satisfaction to patients and health care providers
Scientific title
A new e-health model of care for management of chronic disease: determining safety, efficacy and satisfaction to patients with Chronic Hepatitis C (CHC) and health care providers
Secondary ID [1] 291062 0
None
Universal Trial Number (UTN)
Trial acronym
HealthElink
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Infection 301856 0
Condition category
Condition code
Infection 301536 301536 0 0
Other infectious diseases
Oral and Gastrointestinal 301887 301887 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 301888 301888 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
HealthELink is an online platform designed to facilitate effective and secure communication between patients and members of their care team (Nurses, Specialists and General Practitioners [GPs]).

The components of the eHealth model of care (intervention via a web-based portal) include:
- Clinical Decision Support System with automated calculation of hepatitis C treatment plan from Australian consensus guidelines. This includes integrated medication interaction assessment via the University of Liverpool database, automatic calculation and interpretation of fibrosis markers and complete hepatitis C treatment plan.
- Secure electronic messaging between GP/Specialist/Nurse, with the option of specialist review and electronic approval of treatment plans, and/or remote followup of treatment progress.
- Shared GP/specialist/nurse/patient treatment plan, with any provider able to mark of treatment tasks as complete.
- Electronic patient portal with treatment plan and ability to message the treating team.

This study aims to test HealthELink as a new model of care in the management of patients with chronic hepatitis C compared to the current standard of community treatment via the paper-based remote consultation form.

Arm 1: Chronic Hepatitis C (CHC) – Clinicians treating CHC in the community will be invited to participate in the study, by using the eHealth model for treating CHC. Patients commencing direct antiviral therapy (DAA) via community medical/nurse practitioners as part of standard of care and meeting selection criteria will included in the study unless decision made to opt-out. Patients enrolled into Arm 1 will be offered the option to access their electronic patient portal at enrolment, in addition to their standard of care therapy. Patients will be able to access HealthELink and communicate with their medical care team at any time and at any location with access to the internet, for the duration of the trial (6 months).

Arm 2: Prisoners with CHC – Prison medical officers and nurses will be invited to participate in the study, using the eHealth model of care to treat prisoners in consultation with a tertiary specialist team. Prisoners commencing DAA therapy will be entered into HealthELink by their treating Prison Doctor, unless an opt-out decision is made. There will be no direct interaction between prisoners and HealthELink. This arm aims to test the effectiveness of HealthELink as a means of communication and data tracking between PMOs and Specialists.
Intervention code [1] 297047 0
Treatment: Other
Comparator / control treatment
A historical control group including all remote consultations (i.e community-based HCV) performed at or in consultation with four tertiary centres between 1st March 2016 - 28th February 2017.
Control group
Historical

Outcomes
Primary outcome [1] 301203 0
Sustained Virological Response at 12-weeks post treatment completion (SVR12) measured by Hepatitis C RNA blood test.
Timepoint [1] 301203 0
Measured at minimum 12-weeks post completion of treatment. Follow-up to continue until minimum six-months post treatment.
Primary outcome [2] 301228 0
Treatment initiation rate per practitioner (number of treatments initiated per month) measured by number of assessments entered on the HealthElink system per month enrolled in the system as assessed at the conclusion of the study.
Timepoint [2] 301228 0
End of study (12 months from recruitment)
Secondary outcome [1] 332027 0
User satisfaction measured as assessed on post-study questionnaire. Questionnaire designed specifically for this study with ten likert scale based satisfaction questions.
Timepoint [1] 332027 0
End of study (12 months from recruitment)
Secondary outcome [2] 346217 0
Change in clinician confidence in treating hepatitis C as measured on pre and post study questionnaire designed specifically for this study. Ordinal scale (1-10) asking self-reported confidence in Hepatitis C treatment.
Timepoint [2] 346217 0
Measured prior at time of GP/nurse enrolment and again at the conclusion of the study.

Eligibility
Key inclusion criteria
PATIENTS:
Aged 18-85 years old
Those with the ability to consent
Patients with CHC that requires ongoing follow-up by a Specialist
Those with access to internet
Patients with the ability to converse adequately in spoken and written English.
CHC patients commencing therapy or currently receiving ongoing monitoring and/or therapy
PRISONERS:
Current incarceration
CHC patients commencing therapy or currently receiving ongoing monitoring and/or therapy
GENERAL PRACTITIONERS OR COMMUNITY NURSES:
Correctional medical officers engaged in management of Viral Hepatitis with Hepatologists OR General practitioners who currently co-manage complex Specialist patients
OR Nurses working in outreach/nurse-led community hepatitis C
Special interest in HCV or liver patients
S100 prescribers
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient or their GP with limited or no access to internet
Unable to converse through typing, either due to language barrier or physical disability

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
1/05/2017
Actual
1/08/2017
Date of last participant enrolment
Anticipated
1/05/2018
Actual
28/02/2020
Date of last data collection
Anticipated
1/05/2019
Actual
30/08/2020
Sample size
Target
250
Accrual to date
Final
307
Recruitment in Australia
Recruitment state(s)
NT,SA,TAS,VIC
Recruitment hospital [1] 7547 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 7548 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 7549 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [4] 10808 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 10809 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 10810 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [7] 18869 0
Royal Hobart Hospital - Hobart
Recruitment hospital [8] 18870 0
Western Hospital - Footscray - Footscray
Recruitment postcode(s) [1] 15436 0
5000 - Adelaide
Recruitment postcode(s) [2] 15437 0
3050 - Parkville
Recruitment postcode(s) [3] 15438 0
0810 - Tiwi
Recruitment postcode(s) [4] 22548 0
3128 - Box Hill
Recruitment postcode(s) [5] 22549 0
5042 - Bedford Park
Recruitment postcode(s) [6] 22550 0
5011 - Woodville
Recruitment postcode(s) [7] 33374 0
7000 - Hobart
Recruitment postcode(s) [8] 33375 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 295502 0
Commercial sector/Industry
Name [1] 295502 0
Bristol-Myers Squibb Grants
Country [1] 295502 0
Australia
Funding source category [2] 295715 0
Hospital
Name [2] 295715 0
Royal Melbourne Hosptial Foundation - Foundation Grant Program
Country [2] 295715 0
Australia
Funding source category [3] 295729 0
Commercial sector/Industry
Name [3] 295729 0
MSD Australia Grant
Country [3] 295729 0
Australia
Funding source category [4] 295730 0
Commercial sector/Industry
Name [4] 295730 0
GESSIT Pty Ltd
Country [4] 295730 0
Australia
Funding source category [5] 299353 0
Government body
Name [5] 299353 0
BISI Grant
Country [5] 299353 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia
5000
Country
Australia
Secondary sponsor category [1] 294322 0
None
Name [1] 294322 0
Address [1] 294322 0
Country [1] 294322 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296830 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 296830 0
Ethics committee country [1] 296830 0
Australia
Date submitted for ethics approval [1] 296830 0
02/03/2016
Approval date [1] 296830 0
08/07/2016
Ethics approval number [1] 296830 0
HREC/16/RAH/66

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

Contacts
Principal investigator
Name 72158 0
Dr Edmund Tse
Address 72158 0
Head of Hepatology
Royal Adelaide Hospital
Department of Gastroenterology and Hepatology
Adelaide
North Terrace, SA, 5000
Country 72158 0
Australia
Phone 72158 0
+618 8222 2412
Fax 72158 0
Email 72158 0
edmund.tse@sa.gov.au
Contact person for public queries
Name 72159 0
James Haridy
Address 72159 0
Royal Adelaide Hospital
Department of Hepatology
Level 7 OPD, North Terrace
Adelaide, 5000, SA
Country 72159 0
Australia
Phone 72159 0
+618 82224248
Fax 72159 0
Email 72159 0
james.haridy@mh.org.au
Contact person for scientific queries
Name 72160 0
James Haridy
Address 72160 0
Royal Adelaide Hospital
Department of Hepatology
Level 7 OPD, North Terrace
Adelaide, 5000, SA
Country 72160 0
Australia
Phone 72160 0
+618 82224248
Fax 72160 0
Email 72160 0
james.haridy@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Given confidentiality limitations and sensitive data regarding hepatitis C status IPD will not be available.


What supporting documents are/will be available?

No Supporting Document Provided



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.