Plain English Summary
Background and study aims
Total knee replacement (TKR) is a very common operation mainly carried out in older people with knee arthritis. Although TKR surgery is usually successful, around one in six patients are not satisfied with their recovery following TKR surgery. Providing pre-operative care, such as information and exercises, can help patients prepare for TKR surgery and recover better after surgery. However, current pre-operative TKR services vary, do not meet all patients’ needs and are expensive to deliver. Providing pre-operative TKR care using a website could help improve this, but existing TKR websites have many limitations. This study aim to address this by developing a new website – the ‘Virtual Knee School’ (VKS). The VKS will provide pre-operative care for patients waiting for TKR surgery.
Who can participate?
Adults aged at least 18 years old who are waiting for TKR surgery or who have had TKR surgery within the past two years, and who are able to use and have access to the Internet and email
What does the study involve?
The researchers plan to develop the VKS using five phases:
Phase 1: Develop an agreed list of recommendations on pre-operative TKR care using an approach known as a Delphi Consensus Technique. This involves a group of patients and professionals completing three online questionnaires
Phase 2: Use interviews and/or group discussions with patients to explore what might encourage patients to use the VKS or prevent them from using it.
Phase 3: Use theory (ideas about what affects people’s behaviour) to guide how they develop the VKS.
Phase 4: Develop an early version of the VKS based on the findings of Phases 1-3 and use patient feedback to gradually improve it.
Phase 5: Give patients access to the VKS, monitor how they use it for 4 weeks, and explore their views of it using questionnaires and interviews.
What are the possible benefits and risks of participating?
Some participants in this study will be able to try using the VKS. These participants may find using the VKS helps them prepare for their TKR surgery. However, participants in this study may not gain any direct benefits from taking part. The researchers do not expect there to be any significant risks associated with taking part in this study. However, they will monitor whether the participants who try using the VKS experience any falls or other health problems which could be related to using the VKS.
Where is the study run from?
1. Chapel Allerton Hospital (UK)
2. University of Leeds (UK)
When is the study starting and how long is it expected to run for?
June 2019 to December 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Anna Anderson
A.Anderson@leeds.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Miss Anna Anderson
ORCID ID
http://orcid.org/0000-0002-4048-6880
Contact details
Leeds Institute of Rheumatic and Musculoskeletal Medicine
2nd Floor
Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
+44 (0)113 3924920
A.Anderson@leeds.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 45114, IRAS 262809
Study information
Scientific title
Development and process evaluation of a pre-operative education and prehabilitation digital intervention for patients awaiting total knee replacement: a Virtual Knee School
Acronym
Study hypothesis
This study does not have a formal hypothesis because it is focused on developing a new intervention.
The aim of the study is to develop a pre-operative TKR education and prehabilitation digital intervention, the ‘Virtual Knee School’ (VKS), and explore its implementation and acceptability amongst patients awaiting TKR.
Ethics approval
Approved 10/04/2020, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)2071048083; bradfordleeds.rec@hra.nhs.uk), REC ref: 20/YH/0095
Study design
Non-randomised; Both; Design type: Treatment, Education or Self-Management, Psychological & Behavioural, Complex Intervention, Rehabilitation, Other, Qualitative
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Internet
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Total knee replacement surgery
Intervention
The Virtual Knee School will be an interactive multimedia website that provides pre-operative care to patients waiting for total knee replacement surgery. The Virtual Knee School will be developed during this study. Therefore, it is it is not possible to specify exactly what it will include at this stage. However, it is anticipated it will include pre-operative education, an exercise programme and support with making healthy lifestyle changes.
The researchers will give patients access to the VKS, monitor how they use it for 4 weeks, and explore their views of it using questionnaires and interviews.
Intervention type
Other
Phase
Drug names
Primary outcome measure
This study does not include any primary and secondary outcome measures because it is focused on developing a new intervention.
The majority of the data collected during this study will be qualitative. However, during Phase 5, information will be collected about: participants’ clinical and sociodemographic characteristics, their use of technology, the TKR care they have received, their views of the VKS, their engagement with the VKS and the safety of the VKS, using online questionnaires administered at baseline and 4 weeks. In addition, during Phase 5, data about participants’ use of the VKS will be automatically recorded through the VKS.
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/06/2019
Overall trial end date
17/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Phases 2, 4 and 5:
1. Adult (aged 18 years old or older)
2. Able to communicate in English
3. Able to use and have access to the Internet and email
Phases 2 and 4 only:
1. Listed for primary TKR at a hospital in the United Kingdom or have undergone primary TKR at a hospital in the United Kingdom within the past two years
Phase 5 only:
1. Listed for primary TKR at a hospital in the United Kingdom
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 51; UK Sample Size: 51
Participant exclusion criteria
Phases 2, 4 and 5:
1. Unable to provide informed consent
Phase 5 only:
1. Currently participating in any other research investigating an intervention(s) delivered in the pre-operative phase of the TKR care pathway
Recruitment start date
30/04/2020
Recruitment end date
31/10/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Teaching Hospitals NHS Trust
Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
Trial participating centre
University of Leeds
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
Sponsor information
Organisation
University of Leeds
Sponsor details
c/o Clare E Skinner
Faculty of Medicine and Health Research Office
Room 9.29
Worsley Building
Leeds
LS2 9NL
United Kingdom
+44 (0)113 343 4897
governance-ethics@leeds.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Academy; Grant Codes: ICA-CDRF-2018-04-ST2-006
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The researchers do not have any plans to make additional documents available.
The dissemination and reporting plans for this study will be finalised with the Project Advisory Group and are anticipated to include:
1. Provision of plain English summaries for participants
2. Presentation(s) to the NIHR Leeds Biomedical Research Centre Patient and Public Involvement group
3. Publication in a peer-reviewed journal(s)
4. Presentation at a professional conference(s)
5. Sharing with professionals, patients and the public through social media
6. Reporting in Anna Anderson’s PhD thesis
It is anticipated the final results will be published by June 2023
IPD sharing statement
The datasets generated during the current study are not expected to be made available because they will relate to the specific digital intervention being developed and so will not have wider applicability.
Intention to publish date
01/06/2023
Participant level data
Not expected to be available
Basic results (scientific)
Publication list