Development of a pre-operative care website for patients waiting for total knee replacement surgery – a Virtual Knee School
| ISRCTN | ISRCTN11759773 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11759773 |
| IRAS number | 262809 |
| Secondary identifying numbers | CPMS 45114, IRAS 262809 |
- Submission date
- 20/04/2020
- Registration date
- 24/04/2020
- Last edited
- 25/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
What does the study involve?
The researchers plan to develop the VKS using fourphases:
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 the development of 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.
The details in this record are for Phases 2-4 because Phase 1 was covered by a separate protocol and ethics application.
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 that 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.
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 January 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Anna Anderson
A.Anderson@leeds.ac.uk
Contact information
Scientific
Leeds Institute of Rheumatic and Musculoskeletal Medicine
2nd Floor
Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
 ORCID ID |
0000-0002-4048-6880 |
|---|---|
| Phone | +44 (0)113 3924920 |
| A.Anderson@leeds.ac.uk |
Study information
| Study design | Non-randomised; Both; Design type: Treatment, Education or Self-Management, Psychological & Behavioural, Complex Intervention, Rehabilitation, Other, Qualitative |
|---|---|
| Primary study design | Other |
| Secondary study design | |
| Study setting(s) | Internet/virtual |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Development of a pre-operative education and prehabilitation digital intervention for patients awaiting total knee replacement: a Virtual Knee School |
| Study acronym | VKS |
| Study objectives | Current hypothesis as of 31/08/2021: 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). _____ Previous 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(s) | 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 |
| Health condition(s) or problem(s) studied | Total knee replacement surgery |
| Intervention | Current intervention as of 31/08/2021: The Virtual Knee School will be an interactive multimedia website that provides pre-operative care to patients waiting for total knee replacement (TKR) 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. During Phase 4 of this study, participants will be asked to share their views of the Virtual Knee School through two interviews. During each interview, participants will be asked to work through the Virtual Knee School and say out loud whatever they are thinking. This is known as a 'think aloud interview'. _____ Previous 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 |
| Primary outcome measure | Current primary outcome measure as of 31/08/2021: 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, information about participants’ clinical and sociodemographic characteristics will also be collected. _____ Previous 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 study start date | 01/06/2019 |
| Completion date | 20/01/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: Approximately 21; UK Sample Size: Approximately 21 (Phases 2 and 4) |
| Total final enrolment | 24 |
| Key inclusion criteria | Current inclusion criteria as of 31/08/2021: 1. Adult (aged 18 years old or older) 2. Able to communicate in English 3. Listed for primary TKR at a hospital in the United Kingdom and/or have undergone primary TKR at a hospital in the United Kingdom within the past two years 4. Able to use and have access to the Internet and email (Phase 2 only) 5. Able to use and have access to the Internet and email and/or be willing and able to be interviewed in person (Phase 4 only). Potential participants will be considered able to be interviewed in person if they live in West Yorkshire and meeting in person is permitted by the most up-to-date COVID-19 guidance from the government and University of Leeds. _____ Previous 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 |
| Key exclusion criteria | Current exclusion criteria as of 01/09/2021: 1. Unable to provide informed consent _____ Previous 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 |
| Date of first enrolment | 30/04/2020 |
| Date of final enrolment | 20/01/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
Leeds
LS2 9JT
United Kingdom
Sponsor information
University/education
c/o Clare E Skinner
Faculty of Medicine and Health Research Office
Room 9.29
Worsley Building
Leeds
LS2 9NL
England
United Kingdom
| Phone | +44 (0)113 343 4897 |
|---|---|
| governance-ethics@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3.0 | 04/08/2021 | 22/08/2022 | No | No |
| Thesis results | 02/12/2022 | 19/12/2022 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 22/08/2023 | 25/08/2023 | Yes | No |
Additional files
Editorial Notes
25/08/2023: Publication reference added.
19/12/2022: Thesis link added.
30/08/2022: Total final enrolment added.
22/08/2022: Protocol file uploaded.
07/02/2022: The following changes were made to the trial record:
1. The overall end date was changed from 22/04/2022 to 20/01/2022.
2. The recruitment end date was changed from 31/03/2022 to 20/01/2022.
3. The plain English summary was updated to reflect these changes.
01/09/2021: The following changes have been made:
1. The scientific title has been changed from "Development and process evaluation of a pre-operative education and prehabilitation digital intervention for patients awaiting total knee replacement: a Virtual Knee School" to "Development of a pre-operative education and prehabilitation digital intervention for patients awaiting total knee replacement: a Virtual Knee School".
2. The participant exclusion criteria have been changed.
3. The 'risks and benefits' section of the plain English summary has been updated.
31/08/2021: The following changes have been made:
1. The trial acronym has been added.
2. The study hypothesis has been changed.
3. The primary study design has been changed from "Interventional" to "Other".
4. The trial type has been changed from "Treatment" to "Other".
5. The overall trial end date has been changed from 17/12/2021 to 22/04/2022.
6. The intervention has been changed.
7. The primary outcome measure has been changed.
8. The participant inclusion criteria have been changed.
9. The target number of participants has been changed from "Planned Sample Size: 51; UK Sample Size: 51" to "Planned Sample Size: Approximately 21; UK Sample Size: Approximately 21 (Phases 2 and 4)".
10. The recruitment end date has been changed from 31/10/2021 to 31/03/2022.
11. The plain English summary has been updated to reflect these changes.
20/04/2020: Trial's existence confirmed by the NIHR.
