Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202010744878665 Date of Approval: 30/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Does the use of video improve patient satisfaction in the consent process for local-anaesthetic urological procedures?
Official scientific title The use of video to improve patient satisfaction in the consent process for urological procedures: a single-centre, randomised and controlled trial
Brief summary describing the background and objectives of the trial The primary objective of this study is to assess patient satisfaction with the use of Portable Video Media (PVM) for the purpose of taking informed consent for common urological outpatient-procedures performed under local anaesthesia. Three outpatient urologic procedures were included in this research: flexible cystoscopy with or without () bladder biopsy, flexible cystoscopy with the insertion or removal of a “Double-J” (DJ) ureteric stent, and transrectal ultrasound-guided (TRUS) prostate biopsy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 03/07/2017
Actual trial start date 03/08/2017
Anticipated date of last follow up 30/04/2019
Actual Last follow-up date 30/04/2019
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard verbal consent Not a drug trial. Not applicable The study involved each patient participating in both arms of the study, those being portable video media (PVM) for the purpose of consent and standard verbal consent (SVC) with a doctor. All patients also received a procedure-specific patient information leaflet prior to undergoing consent. Standard verbal consent (SVC) acted as the "control" arm, as the traditional (historical) form of consent. Verbal consent was undertaken by urology registrars at Groote Schuur hospital, with no scripting provided. 60 Historical
Experimental Group Portal video media consent Not a drug trial Not applicable As either the initial intervention or following crossover, all participants underwent Portable video media consent as the "experimental" arm. 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients enrolled were required to be: Older than 18 years of age Able to watch a video Able to speak at least one of the following three languages: English, isiXhosa and Afrikaans. Illiterate patients could be included: a doctor or nurse in the urology team was available to read the relevant documentation to these patients. Patients without the capacity to give informed consent were excluded. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/03/2019 Human Research Ethics committee of University of Cape Town
Ethics Committee Address
Street address City Postal code Country
G50 Old Main Building Groote Schuur Hospital Anzio Road Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/08/2017 Human Research Ethics Committee University of Cape Town
Ethics Committee Address
Street address City Postal code Country
G50 Old Main Building Groote Schuur Hospital, Anzio road, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Patient satisfaction with portable video media versus standard verbal consent At completion of questionnaire
Secondary Outcome Benefit of patient information leaflets as an adjunct to portable video media At completion of questionnaire
Secondary Outcome Whether portable video media improved patient understanding of the procedure they were due to undergo At completion of questionnaire
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Hospital Anzio road Cape Town 7925 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Urology University of Cape Town Funding for Masters in Medicine Groote Schuur Hospital Observatory Cape Town 7925 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Urology University of Cape Town Groote Schuur hospital, Observatory Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Justin Howlett Urology Department, Groote Schuur hospital, Anzio road, Observatory Cape Town 7925 South Africa
Manraj Phull Watford General Hospital Watford Hertfordshire United Kingdom
Lukhona Mpungose Faculty of Health Sciences, University of Cape Town, Observatory Cape Town 7925 South Africa
Sebastian Samson Faculty of Health Sciences, University of Capw Town, Observatory Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Allison Moore allisonmoore1986@gmail.com 0027726045195 13 St Michaels road, Claremont
City Postal code Country Position/Affiliation
Cape Town 7708 South Africa Registrar Department of Urology University of Cape Town
Role Name Email Phone Street address
Public Enquiries Allison Moore allisonmoore1986@gmail.com 0027726045195 13 St Michaels road, Claremont
City Postal code Country Position/Affiliation
Cape Town 7708 South Africa Registrar Department of Urology University of Cape Town
Role Name Email Phone Street address
Scientific Enquiries Allison Moore allisonmoore1986@gmail.com 0027726045195 13 St Michaels road, Claremont
City Postal code Country Position/Affiliation
Cape Town 7708 South Africa Registrar Department of Urology University of Cape Town
Role Name Email Phone Street address
Principal Investigator Justin Howlett howlettjustin@gmail.com 0027721965014 Groote Schuur hospital, Anzio road, Observatory
City Postal code Country Position/Affiliation
Cape Town South Africa Consultant Department of Urology University of Cape Town
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes There is a plan to make IPD and related supporting information available. All collected IPD will be available for sharing. Clinical Study Report,Informed Consent Form,Study Protocol The IPD and additional supporting information will become available 6 months after publication. The information will be available for a period of 10 years. IPD and additional supporting information will be shared with researchers who provide a methodologically sound proposal for access.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Research is not currently published No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information