Condition category
Musculoskeletal Diseases
Date applied
20/04/2020
Date assigned
24/04/2020
Last edited
24/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.leeds.ac.uk/

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

Publication citations

Additional files

Editorial Notes

20/04/2020: Trial's existence confirmed by the NIHR.