Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576557
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Knowledge Translation and Exercise for Degenerative Meniscal Tears and Early Osteoarthritis KNEE-DEeP Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Knowledge Translation and Exercise for Degenerative Meniscal Tears and Early Osteoarthritis the KNEE-DEeP Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KNEE-DEeP
Brief Summary:
Knee pain due to a degenerative meniscal tear DMT or early osteoarthritis OA is a frequent presentation in middle-aged and older adults In the knee joint a DMT can occur normally with age but is also associated with the continuum of knee OA Exercise is recommended as the main treatment to aid recovery while an arthroscopy camera in the knee to remove torn cartilage does not provide any additional benefit Despite this many patients in Ireland with this type of knee pain are referred to an orthopaedic surgeon by their GP and do not receive recommended care from their physiotherapist
The first phase of this project designed the KNEE-DEeP Knowledge Translation and Exercise for Early Degenerative Knee Pain intervention to deliver better care to patients with DMT and early OA The overall aim of this feasibility study is to test the KNEE-DEeP intervention to ensure it can be delivered as planned and it is acceptable to patients and health care professionals HCPs involved in intervention delivery GPs and physiotherapists This is in preparation for carrying out a larger future trial
As part of the intervention GPs and physiotherapists will receive an educational workshop Patient participants in turn will receive an enhanced consultation from their participating GP and a best practice physiotherapy session focusing on strategies to enhance self-management This approach will be tested out by enrolling 15 GPs five physiotherapist and 36 patients in the feasibility study Patients will be followed up after 12 weeks and six months to track their progress As part of the evaluation all GPs physiotherapists and patients will complete questionnaires and a sub-set will provide more in-depth feedback via interviews conducted over the phone or online
The first phase of this project designed the KNEE-DEeP Knowledge Translation and Exercise for Early Degenerative Knee Pain intervention to deliver better care to patients with DMT and early OA The overall aim of this feasibility study is to test the KNEE-DEeP intervention to ensure it can be delivered as planned and it is acceptable to patients and health care professionals HCPs involved in intervention delivery GPs and physiotherapists This is in preparation for carrying out a larger future trial
As part of the intervention GPs and physiotherapists will receive an educational workshop Patient participants in turn will receive an enhanced consultation from their participating GP and a best practice physiotherapy session focusing on strategies to enhance self-management This approach will be tested out by enrolling 15 GPs five physiotherapist and 36 patients in the feasibility study Patients will be followed up after 12 weeks and six months to track their progress As part of the evaluation all GPs physiotherapists and patients will complete questionnaires and a sub-set will provide more in-depth feedback via interviews conducted over the phone or online
Detailed Description:
KNEE-DEeP Intervention Design
The KNEE-DEeP intervention was designed to address modifiable barriers at the patient provider and system level to evidence based care for DMT and early OA According to the Medical Research Councils guidance on the development and evaluation of complex healthcare interventions a multi-component strategy is needed to address these barriers using the best available evidence and appropriate theory
The intervention was designed using the Behavioural Change Wheel BCW eight-step process The Theoretical Domains Framework TDF was used to identify relevant determinants of change and develop an in-depth understanding of each target behaviour The KNEE-DEeP intervention will target both GPs and physiotherapists and their patients with early OA and DMT GPs will receive a training workshop and educational resources to facilitate an enhanced clinical consultation about this type of knee pain Given the emphasis placed by Irish GPs on timely access to physiotherapy in managing this condition early access to a single best practice session of physiotherapy will be a key component of the patient intervention to address this service-level barrier The content of the patient intervention delivered by the GP and physiotherapist will be underpinned by clinical practice guidelines stakeholder input and the evidence base on management of chronic knee pain
Specific KNEE-DEeP study objectives are
1 Determine the acceptability of the intervention content and delivery to HCPs and patients
2 Determine adherence of GPs and physiotherapists to study processes around intervention delivery to patients
3 Assess fidelity related to intervention delivery and intervention receipt from the perspectives of HCPs and patients
4 Determine if data collection procedures and outcome measures are feasible and acceptable to HCPs and patients
5 Determine feasibility of HCP and patients recruitment and retention procedures
6 Investigate the magnitude of change and variability in the clinical outcome measures
Study Design and Setting
The KNEE-DEeP study is a non-randomised feasibility study that includes an embedded mixed methods process evaluation Assessments will be performed at baseline 12 weeks primary endpoint and 24 weeks Recruitment is anticipated to last 6 months with each patient participant taking part in the trial for 6 months and the last follow-up due 12 months after the start of recruitment
Set in general practices in Kerry and North Cork and in the Physiotherapy Department of University Hospital Kerry UHK a publicly funded hospital also in the South-West of Ireland
A single arm feasibility study was chosen rather than a comparative design because the main focus was to resolve uncertainties about the acceptability and feasibility of the intervention itself and its mode of delivery A non-randomised design was deemed suitable as it was an opportunity to test the intervention with a greater number of HCP and patient participants
Sample Size
As this is a feasibility study a formal sample size calculation has not been carried out
The KNEE-DEeP intervention was designed to address modifiable barriers at the patient provider and system level to evidence based care for DMT and early OA According to the Medical Research Councils guidance on the development and evaluation of complex healthcare interventions a multi-component strategy is needed to address these barriers using the best available evidence and appropriate theory
The intervention was designed using the Behavioural Change Wheel BCW eight-step process The Theoretical Domains Framework TDF was used to identify relevant determinants of change and develop an in-depth understanding of each target behaviour The KNEE-DEeP intervention will target both GPs and physiotherapists and their patients with early OA and DMT GPs will receive a training workshop and educational resources to facilitate an enhanced clinical consultation about this type of knee pain Given the emphasis placed by Irish GPs on timely access to physiotherapy in managing this condition early access to a single best practice session of physiotherapy will be a key component of the patient intervention to address this service-level barrier The content of the patient intervention delivered by the GP and physiotherapist will be underpinned by clinical practice guidelines stakeholder input and the evidence base on management of chronic knee pain
Specific KNEE-DEeP study objectives are
1 Determine the acceptability of the intervention content and delivery to HCPs and patients
2 Determine adherence of GPs and physiotherapists to study processes around intervention delivery to patients
3 Assess fidelity related to intervention delivery and intervention receipt from the perspectives of HCPs and patients
4 Determine if data collection procedures and outcome measures are feasible and acceptable to HCPs and patients
5 Determine feasibility of HCP and patients recruitment and retention procedures
6 Investigate the magnitude of change and variability in the clinical outcome measures
Study Design and Setting
The KNEE-DEeP study is a non-randomised feasibility study that includes an embedded mixed methods process evaluation Assessments will be performed at baseline 12 weeks primary endpoint and 24 weeks Recruitment is anticipated to last 6 months with each patient participant taking part in the trial for 6 months and the last follow-up due 12 months after the start of recruitment
Set in general practices in Kerry and North Cork and in the Physiotherapy Department of University Hospital Kerry UHK a publicly funded hospital also in the South-West of Ireland
A single arm feasibility study was chosen rather than a comparative design because the main focus was to resolve uncertainties about the acceptability and feasibility of the intervention itself and its mode of delivery A non-randomised design was deemed suitable as it was an opportunity to test the intervention with a greater number of HCP and patient participants
Sample Size
As this is a feasibility study a formal sample size calculation has not been carried out
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None