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Trial registered on ANZCTR


Registration number
ACTRN12621000768897
Ethics application status
Approved
Date submitted
27/04/2021
Date registered
21/06/2021
Date last updated
7/10/2022
Date data sharing statement initially provided
21/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
eConsent for kidney biopsy: impact on the patient experience
Scientific title
The patient experience of kidney biopsy: A randomised controlled trial evaluating video-assisted consent versus standard consent for percutaneous ultrasound-guided kidney biopsy in adults
Secondary ID [1] 302186 0
None
Universal Trial Number (UTN)
U1111-1256-3099
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Percutaneous Kidney Biopsy 318853 0
Informed Consent 318854 0
Condition category
Condition code
Renal and Urogenital 316856 316856 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the video-assisted (intervention) group will watch a 6 minute audiovisual consent animation describing the procedure of percutaneous kidney biopsy. This will be shown prior to the participant's consultation with their doctor.

Content of the animation video is based on the recently published national CARI guidelines and its translation into the kidney biopsy pathway, approved by the RBWH Forms Review Committee. The final video is structured into 10 sections: “reasons for kidney biopsy”, “preparing for kidney biopsy”, “the procedure”, “post-procedure”, “benefits”, “risks of not having a kidney biopsy”, “alternatives”, “risks of kidney biopsy”, “patients at increased risk of
complications” and “conclusion”.

The audio narrative steps the participant through what is displayed in the video. The visual content is augmented by written subtitles and captions.The patient-centric animation was developed in English and will be translated into five other commonly spoken languages (Vietnamese, Arabic, Mandarin, Cantonese and Spanish).
Intervention code [1] 318485 0
Other interventions
Comparator / control treatment
Participants in the control group will be consented following the current conventional consent process, i.e. conversation with a medical practitioner prior to signing the consent form.
Control group
Active

Outcomes
Primary outcome [1] 324965 0
Patient’s comprehension, evaluated using a 10-item knowledge questionnaire developed specifically for the study.
Timepoint [1] 324965 0
Immediately after signing the consent form.
Secondary outcome [1] 386372 0
Patient reported experience measure (PREM), assessed by a modified KidneyPREM.
Timepoint [1] 386372 0
Immediately after signing the consent form.
Secondary outcome [2] 386373 0
Spielberger State-Trait Anxiety Inventory (STAI Y-6 Item)
Timepoint [2] 386373 0
At 2 timepoints:
Baseline- immediately before watching the consent animation (intervention group) or immediately before talking with their doctor (control group)
Immediately after signing the consent form
Secondary outcome [3] 386374 0
Five-point Likert scale, to evaluate satisfaction with the informed consent process
Timepoint [3] 386374 0
Immediately after signing the consent form.
Secondary outcome [4] 386375 0
Recorded time taken to consent (in minutes), as measured by a digital stopwatch.
Timepoint [4] 386375 0
Control group: from when the participant begins their consultation with their doctor to when they sign the consent form.
Intervention group: from when the participant begins to watch the animation video to when they sign the consent form.

Eligibility
Key inclusion criteria
All consecutive patients scheduled to undergo a percutaneous kidney biopsy will receive information about the study and be invited to participate. Those that agree will be required to sign written informed consent to proceed into the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
< 18 years of age.
Individuals not competent to consent or refuse to consent to medical treatment.
Legally blindness (defined as having corrected acuity of no better than 6/60 and/or a vision field of no more than 10 degrees).

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation performed using a computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analysis will be performed and checked with IBM SPSS Statistics software (version 26.0,IBM Corp, Armonk, NY). Continuous variables will be compared with independent 2-sample t-tests and nominal variables will be compared with x2. Analysis of covariance will be used to compare baseline (pre-consent) and final (post-consent) Spielberger State-Trait Anxiety Inventory scores.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
21/07/2021
Date of last participant enrolment
Anticipated
8/05/2023
Actual
Date of last data collection
Anticipated
8/05/2023
Actual
Sample size
Target
120
Accrual to date
54
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17373 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 31102 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 306607 0
Charities/Societies/Foundations
Name [1] 306607 0
RBWH research foundation
Country [1] 306607 0
Australia
Primary sponsor type
Individual
Name
Pedro Henrique Franca Gois
Address
Nephrology Department - Fraser Coast Hospital and Health Service
Cnr Nissen Street &, Urraween Rd, Pialba QLD 4655
Country
Australia
Secondary sponsor category [1] 307140 0
Individual
Name [1] 307140 0
Martin Wolley
Address [1] 307140 0
Kidney Health Service
Metro North Hospital and Health Service
Level 9 Butterfield Street, Herston QLD 4029.
Country [1] 307140 0
Australia
Other collaborator category [1] 281443 0
Individual
Name [1] 281443 0
Marina Wainstein
Address [1] 281443 0
Kidney Health Service
Metro North Hospital and Health Service
Level 9 Butterfield Street, Herston QLD 4029.
Country [1] 281443 0
Australia
Other collaborator category [2] 281444 0
Individual
Name [2] 281444 0
Helen Healy
Address [2] 281444 0
Kidney Health Service
Metro North Hospital and Health Service
Level 9 Butterfield Street, Herston QLD 4029.
Country [2] 281444 0
Australia
Other collaborator category [3] 281445 0
Individual
Name [3] 281445 0
Ann Bonner
Address [3] 281445 0
G16 Clinical Sciences 2, Level 2.15
Griffith University, Southport, QLD 4215
Country [3] 281445 0
Australia
Other collaborator category [4] 281446 0
Individual
Name [4] 281446 0
Rebecca Sauderson
Address [4] 281446 0
Drummoyne Dermatology
Suite 1, 109 Victoria Road,
Drummoyne NSW 2047.
Country [4] 281446 0
Australia
Other collaborator category [5] 281447 0
Individual
Name [5] 281447 0
Vera Yueyue Miao
Address [5] 281447 0
Drummoyne Dermatology
Suite 1, 109 Victoria Road,
Drummoyne NSW 2047.
Country [5] 281447 0
Australia
Other collaborator category [6] 281448 0
Individual
Name [6] 281448 0
Kylie-Anne Mallitt
Address [6] 281448 0
Centre for Big Data Research in Health
UNSW Australia
Sydney NSW 2052, Australia
Country [6] 281448 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306800 0
Nepean Blue Mountains Local Health District Human Research Ethics Committee
Ethics committee address [1] 306800 0
Ethics committee country [1] 306800 0
Australia
Date submitted for ethics approval [1] 306800 0
12/06/2018
Approval date [1] 306800 0
18/07/2018
Ethics approval number [1] 306800 0
HREC/18/Nepean/78
Ethics committee name [2] 308404 0
RBWH - Human Research Ethics Committee
Ethics committee address [2] 308404 0
Ethics committee country [2] 308404 0
Australia
Date submitted for ethics approval [2] 308404 0
19/10/2020
Approval date [2] 308404 0
03/12/2020
Ethics approval number [2] 308404 0
LNR/2020/QRBW/69706

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

Contacts
Principal investigator
Name 105042 0
Dr Pedro Henrique Franca Gois
Address 105042 0
Nephrology Department - Fraser Coast Hospital and Health Service
Cnr Nissen Street &, Urraween Rd, Pialba QLD 4655
Country 105042 0
Australia
Phone 105042 0
+61 743256113
Fax 105042 0
Email 105042 0
Pedro.FrancaGois@health.qld.gov.au
Contact person for public queries
Name 105043 0
Pedro Henrique Franca Gois
Address 105043 0
Nephrology Department - Fraser Coast Hospital and Health Service
Cnr Nissen Street &, Urraween Rd, Pialba QLD 4655
Country 105043 0
Australia
Phone 105043 0
+61 743256113
Fax 105043 0
Email 105043 0
Pedro.FrancaGois@health.qld.gov.au
Contact person for scientific queries
Name 105044 0
Pedro Henrique Franca Gois
Address 105044 0
Nephrology Department - Fraser Coast Hospital and Health Service
Cnr Nissen Street &, Urraween Rd, Pialba QLD 4655
Country 105044 0
Australia
Phone 105044 0
+61 743256113
Fax 105044 0
Email 105044 0
Pedro.FrancaGois@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.