COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

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 registered on ANZCTR


Registration number
ACTRN12620000897965
Ethics application status
Approved
Date submitted
11/06/2020
Date registered
11/09/2020
Date last updated
11/09/2020
Date data sharing statement initially provided
11/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electronic informed consent (e-consent) in low risk research projects
Scientific title
Electronic informed consent (e-consent) in low risk research projects; a randomised control trial sub-study of electronic and video animation consent compared to traditional consent practices
Secondary ID [1] 301196 0
None
Universal Trial Number (UTN)
U1111-1253-4230
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Consent for participants in a clinical trial 317343 0
Condition category
Condition code
Other 315450 315450 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is a sub-study to a larger clinical trial. This sub-study is a randomised control trial assessing improved patient informed consent comparing electronic video/animation consent to traditional paper based consent methods.
Video/electronic consent -Participants will be emailed a link to watch a 10-minute video animation outlining the "parent study = A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform; NCT03737149; ". This animation will outline the research procedure, study aims, risks, potential benefits, alternatives to participation, and introduce the research study team.
Participants will then be asked a series of questions about the trial to assess their understanding and their participation in the trial, and their satisfaction of the video consent method. Participants will be able to sign their consent form electronically. After completing the knowledge questions, participants will be directed to a page where they may sign and date an electronic patient informed consent form. This will be emailed to the participant who has signed and to the research team. Research staff will review and sign after the next meeting with the participant.
Following this, participants will be called to arrange an appointment with research staff for trial related training. Research staff will sign after the participant has answered all the knowledge questions correctly and are satisfied that the participant is fully informed to participate in the trial.
Understanding and adherence to study protocol will be monitored by research staff.
Intervention code [1] 317499 0
Other interventions
Comparator / control treatment
Control - traditional consent method - the trial is discussed with the patients initially by the treating doctor. The patient is given a paper consent form to read through at home. Patients return to discuss the trial and complete paperwork with the research team.
Control group
Active

Outcomes
Primary outcome [1] 323696 0
To determine if electronic consent improves patient comprehension and understanding of the trial they are being asked to participate in (composite)

Patient comprehension and understanding is achieved by a series of knowledge/understanding check multiple choice questions at the completion of the review of the video animation. The questions were specifically created for this trial based on the information in the informed consent document.
Timepoint [1] 323696 0
These multiple choice questions will be completed immediately after the immediately after the informed consent process (i.e. watching the video animation and opportunity to call/discuss clinical trial queries with eh research team) is complete
Secondary outcome [1] 382646 0
To determine if there is any time saving benefits to video and electronic consent.

Determined by collecting data on duration of consent process, time taking for research staff to conduct and prepare informed consent process. All outcome times will be recorded on a specialised purpose built platform and access by research staff through the trial
(composite timepoint)
Timepoint [1] 382646 0
- Duration of consent process will be taken at all point of the consent process including time spent discussion additional trial questions on the phone or face to face with the participant and additional time spent spent discussing the trial prior to participant having signed for consent.
- Duration of research staff to prepare informed consent information is conducted through the trial. This is preparation of paper based documentation, sending out emails and logistics of information distribution to surgeon's practice rooms.
Secondary outcome [2] 385685 0
To determine if there are cost-saving benefits from using e-consent methods.

Determined by analysing staff time, and resources use (such as paper, printing, travel time to doctor clinics to provide documentation, etc.) (composite timepoints)
Timepoint [2] 385685 0
- Duration of staff time spent discussing trial with participants (any method)
- Duration of staff time travelling to and from locations to provide clinicians with documentation
duration of staff time ensuring trial documentation is uploaded or scanned and put into medical records
- Resources used per participants including printing and paper costs,

Eligibility
Key inclusion criteria
All patients enrolled into the parent study (Zimmer Biomet "mymobility") will be automatically entered in to the e-consent sub-study.
Patients who are participating in parent study but decline to consent electronically will be used as comparisons and will be part of the paper consent cohort.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
This study will include any patients who is participating in the parent study, mymobility by Zimmer Biomet, and has access to a smart phone or tablet or personal computer. Participants will have a basic understanding of technology and will be undergoing a hip or knee replacement/arthroplasty at Epworth HealthCare, under the parent study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants enrolled in the study will be randomised using sealed opaque envelops with equal number of "e-consent" and "traditional consent". These will be randomly selected by a member an independent member of the research team or treating doctor.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using equal numbers of each intervention arm and randomly selected envelope.
Concealment in the envelop will be randomised by statistician independent from the trial who will use software to randomly allocate envelopes to each treatment group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
While this is a pilot study, the parent trial will enrol a minimum of 150 participants. The sub-study will therefore enrol a minimum of 150 participants.
Data collected in this study will be summarized descriptively and descriptive summaries will be the basis of any study reports issued.
Data will be qualitative and quantivative.
Qualitative data will thematically analysed.
All quantitative data collected during this study, including survey data will be full described using means and standard deviations for normally distributed and continuous data. Medians and interquartile ranges for non-normally distributed data will be used. For categorical data, numbers and percentages will be determined and compared. All qualitative data obtained from focus groups and interviews will be transcribed or summarized and analysed thematically.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16859 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 30508 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 305645 0
Hospital
Name [1] 305645 0
Epworth Medical Foundation
Address [1] 305645 0
89 Bridge Road, Richmond, VIC, 3121, Australia
Country [1] 305645 0
Australia
Primary sponsor type
Hospital
Name
Epworth Medical Foundation
Address
89 Bridge Road, Richmond, VIC, 3121, Australia
Country
Australia
Secondary sponsor category [1] 306387 0
None
Name [1] 306387 0
Address [1] 306387 0
Country [1] 306387 0
Other collaborator category [1] 281361 0
Individual
Name [1] 281361 0
Dr Rebecca Saunderson
Address [1] 281361 0
Department of Dermatology
Royal North Shore Hospital
Reserve Road
St Leonard
NSW 2065
Country [1] 281361 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305931 0
Bellberry Limited
Ethics committee address [1] 305931 0
123 Glen Osmond Road Eastwood Adelaide
South Australia 5063
Ethics committee country [1] 305931 0
Australia
Date submitted for ethics approval [1] 305931 0
19/11/2019
Approval date [1] 305931 0
05/02/2020
Ethics approval number [1] 305931 0
2019-09-822-AA

Summary
Brief summary
The purpose of the study is to compare video animation with electronic consent processes to the traditional paperbased PICF method of consent in a clinical trial. Participants will still engage and discuss the clinical trial and their participation with research staff as standard. Participants in the "parent clinical trial" i.e. the larger study looking at orthopaedic rehabilitation post total hip and total knee replacements using apple watches and applications, can opt out of the video/animation study if they chose to while remaining in the parent study.

Participants in the parents study, will be randomised to either the electronic/animation consent group or the paper based consent group. The electronic/animation consent group will be emailed a link to watch a video animation that will explain the parent study. This animation goes for 8 minutes. They will then be asked to review the electronic version of the study PICF to ensure they have reviewed the legal information such as who to contact for trail questions and/or complaints.

Participants in both group will answer knowledge and satisfaction questions to determine how well they have understood their participation in the parent trial and their satisfaction with the method of consent.

This project, aims to determine if electronic/animation consent shows equal or improved participant understanding, saves research staff time, enhances patient satisfaction within a clinical trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102110 0
Mr Camdon Fary
Address 102110 0
Epworth Healthcare, 185-187 Hoddle St, Richmond, VIC, 3121, Australia
Country 102110 0
Australia
Phone 102110 0
+61 0422064221
Fax 102110 0
Email 102110 0
camfary@gmail.com
Contact person for public queries
Name 102111 0
Mrs Anastasia Abela
Address 102111 0
Epworth Healthcare, 185-187 Hoddle Street, Richmond, VIC, 3121, Australia
Country 102111 0
Australia
Phone 102111 0
+61 0415261869
Fax 102111 0
Email 102111 0
stasie.abela@epworth.org.au
Contact person for scientific queries
Name 102112 0
Mrs Anastasia Abela
Address 102112 0
Epworth Healthcare, 185-187 Hoddle Street, Richmond, VIC, 3121, Australia
Country 102112 0
Australia
Phone 102112 0
+61 0415261869
Fax 102112 0
Email 102112 0
stasie.abela@epworth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Time taken for consultations, time taken for phone calls, knowledge scores, satisfaction with consent method score and drop out rates.
When will data be available (start and end dates)?
At the completion of 150 participants recruited

End date 31/10/2021. Data will be available 2 months after study participant recruitment has ceased; 31/12/2021. Data will be available for 24-months post study completion via contact the Principal Investigator, and through publications that arise from this study.
Available to whom?
Case-by-case basis for interested parties who can contact the Principal Investigator
Available for what types of analyses?
To achieve aims of the study protocol
How or where can data be obtained?
Subject to approval by the Principal Investigator (stasie.abela@epworth.org.au)
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7862 0
Informed consent form
Citation [1] 7862 0
Email [1] 7862 0
Other [1] 7862 0
2 types of consent information.
- Paperbased consent attached
- Video animation link: https://drive.google.com/file/d/1tgXo1MldY5tuCFXC-u_rD9Sw58Hp-D2r/view?usp=sharing
Type [2] 7863 0
Ethical approval
Citation [2] 7863 0
Link [2] 7863 0
Email [2] 7863 0
Other [2] 7863 0
Summary results
No Results