None listed
Conditions
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.
Interventions
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 p
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.
Sponsors
Epworth Medical Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed