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.: PACTR202207569764052 Date of Approval: 08/07/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Does increased peri-operative communication improve patient satisfaction after Total Joint Arthroplasty? A randomised controlled trial
Official scientific title Does increased peri-operative communication improve patient satisfaction after Total Joint Arthroplasty? A randomised controlled trial
Brief summary describing the background and objectives of the trial Total joint arthroplasty (TJA) is a very successful procedure. It is reported with relatively high satisfaction rates. One of the pillars in improving patient satisfaction is strengthened communication between surgeons and patients. Technology has made this easier and convenient. The aim of this trial was to determine whether peri-operative cell phone massaging patients undergoing Total Joint Arthroplasty (TJA) improved the satisfaction rate.The objectives of this study were: • To compare the satisfaction rate between the groups that received cell phone messages versus the group that did not. • To compare the hospital experience ratings between the two above mentioned groups. • To compare Patient Reported Outcome Measures (PROMs) between the two groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/08/2019
Actual trial start date 02/09/2019
Anticipated date of last follow up 30/09/2021
Actual Last follow-up date 30/10/2021
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 80
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group cellphones messages 10 6 weeks This group receive peri-operative cellphone messages centred around informed consent and the rehabilitation process. 40
Control Group None 0 0 This group receive standard treatment without the addition of cellphone messages 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All primary TKA/THA patients • Patients 18 years of age and older • All patients who own cell phones • Patients requiring revision surgery • Trauma patients (Neck of femur fractures-NOF) • Patients who did not consent for enrolment into the study 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 25/04/2019 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
7 York road, Parktown Johannesburg Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The satisfaction rate between the groups that received cell phone messages versus the group that did not 6 weeks after surgery
Secondary Outcome • To compare the hospital experience ratings between the two above mentioned groups. • To compare Patient Reported Outcome Measures (PROMs) between the two groups 6 weeks after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Charlotte Maxeke Johannesburg Academic Hospital 7 York street Parktown Johannesburg 2193 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Philani Ian Ntombela 31 Grosvenor road, The Grove Johannesburg 2191 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Philani Ntombela 31 Grosvenor road Johannesburg 2191 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Dr WS Ndou 7 York street Johannesburg 2193 South Africa
Dr M Jingo 7 York road Parktown Johannesburg 2193 South Africa
Dr N Sikhauli 7 York road Parktown Johannesburg 2193 South Africa
Dr L Mokete 7 York road Parktown Johannesburg 2193 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Philani Ntombela philani2086@gmail.com +270762006503 31 Grosvenor road
City Postal code Country Position/Affiliation
Johannesburg 2191 South Africa Orthopaedic surgeon at University of the Witwatersrand
Role Name Email Phone Street address
Scientific Enquiries Solomon Ndou wofhatwandou@gmail.com +270729912240 7 York road
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa University of the Witwatersrand
Role Name Email Phone Street address
Public Enquiries Maxwell Jingo Maxwell.Jingo@wits.ac.za +27767916768 7 York road Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa University of the Witwatersrand
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal. Please contact philani2086@gmail.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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