ANZCTR - Registration

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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]

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

Condition category

Condition code

Other

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]

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]

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]

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]

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]

- 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]

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]

- 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

Sex

Both males and females

Can healthy volunteers participate?

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

10/06/2020

Date of last participant enrolment

Anticipated

3/05/2021

Actual

Date of last data collection

Anticipated

31/05/2021

Actual

Sample size

Target

150

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Epworth Richmond - Richmond

Recruitment postcode(s) [1]

3121 - Richmond

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Epworth Medical Foundation

Address [1]

89 Bridge Road, Richmond, VIC, 3121, Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Epworth Medical Foundation

Address

89 Bridge Road, Richmond, VIC, 3121, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Dr Rebecca Saunderson

Address [1]

Department of Dermatology
Royal North Shore Hospital
Reserve Road
St Leonard
NSW 2065

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Limited

Ethics committee address [1]

123 Glen Osmond Road Eastwood Adelaide
South Australia 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/11/2019

Approval date [1]

05/02/2020

Ethics approval number [1]

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

Mr Camdon Fary

Address

Epworth Healthcare, 185-187 Hoddle St, Richmond, VIC, 3121, Australia

Country

Australia

Phone

+61 0422064221

Fax

[email protected]

Contact person for public queries

Name

Anastasia Abela

Address

Epworth Healthcare, 185-187 Hoddle Street, Richmond, VIC, 3121, Australia

Country

Australia

Phone

+61 0415261869

Fax

[email protected]

Contact person for scientific queries

Name

Anastasia Abela

Address

Epworth Healthcare, 185-187 Hoddle Street, Richmond, VIC, 3121, Australia

Country

Australia

Phone

+61 0415261869

Fax

[email protected]

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 ([email protected])

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
7862	Informed consent form		https://drive.google.com/file/d/1tgXo1MldY5tuCFXC-u_rD9Sw58Hp-D2r/view?usp=sharing		2 types of consent information. - Paperbased cons... [More Details]	379763-(Uploaded-11-06-2020-11-29-10)-Study-related document.pdf
7863	Ethical approval					379763-(Uploaded-11-06-2020-11-29-52)-Study-related document.pdf

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.

Trial Review

Documents added manually

Documents added automatically