Clinical trial NCT06576557: Knowledge Translation and Exercise for Degenerative Meniscal Tears and Early Osteoarthritis: KNEE-DEeP Study
Official title: Knowledge Translation and Exercise for Degenerative Meniscal Tears and Early Osteoarthritis: the KNEE-DEeP Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Meniscus; Degeneration
Keywords: Health Care Quality, Access, and Evaluation
Feasibility Studies
Exercise Therapy
Lead sponsor: University of Limerick
Sponsor class: OTHER
Collaborators: name: Health Research Board, Ireland
First posted: 2024-08-28
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 Council's 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.

Eligibility criteria: Inclusion Criteria for Participants with Knee Pain:

* Attended their GP with an episode of non-traumatic knee pain
* Have knee pain attributed to a DMT or early degenerative changes based on the GP's clinical assessment (this standardised assessment is a component of the GP training)
* Aged between 35 and 69 years inclusive

Exclusion Criteria:

* Recent trauma likely to be associated with considerable tissue damage
* Fulfilling the American College of Rheumatology clinical classification criteria for knee OA (these criteria reflect later signs of OA or established disease)
* Moderate or advanced knee OA on x-ray (or Kellgren-Lawrence x-ray score ≥ Grade 3)
* Having an acutely swollen or locked knee, or suspected ligament injury on physical exam
* Inflammatory arthritis
* Surgery or significant trauma of the index knee within the previous 2 years
* Pregnancy
* Unable to communicate in English
* Preference for accessing physiotherapy treatment privately prior to the 'best practice' session.

Inclusion Criteria for Participating GPs (n=15) and Physiotherapists (n=5):

* Eligible GPs will be working in practices within traveling distance (\< 50 km) of University Hospital Kerry and willing to attend a two-hour training workshop
* Eligible physiotherapists will be involved in the delivery of outpatient musculoskeletal physiotherapy services at University Hospital Kerry and available to participate in training to deliver the 'best practice' physiotherapy intervention

Primary outcomes:
measure: Change in physical function from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in physical function from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS)
timeFrame: Baseline and 24 weeks
measure: Change in knee pain from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Pain Subscale
timeFrame: Baseline and 12 weeks
measure: Change in knee pain from baseline to 24 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Pain Subscale
timeFrame: Baseline and 24 weeks
measure: Change in pain self-efficacy from baseline to 12 weeks as measured by the Pain Self-efficacy (PSEQ 2-item short form)
timeFrame: Baseline and 12 weeks
measure: Change in pain self-efficacy from baseline to 24 weeks as measured by the Pain Self-efficacy (PSEQ 2-item short form)
timeFrame: Baseline and 24 weeks
measure: Change in fear avoidance beliefs from baseline to 12 weeks as measured by the physical activity subscale of the Fear Avoidance Belief Questionnaire (FABQ)
timeFrame: Baseline and 12 weeks
measure: Change in fear avoidance beliefs from baseline to 24 weeks as measured by the physical activity subscale of the Fear Avoidance Belief Questionnaire (FABQ)
timeFrame: Baseline and 24 weeks
measure: Change in health related quality of life from baseline to 12 weeks as measured by the EuroQol Five-Dimensional Questionnaire (EQ-5D-5L)
timeFrame: Baseline and 12 weeks
measure: Change in health related quality of life from baseline to 24 weeks as measured by the EuroQol Five-Dimensional Questionnaire (EQ-5D-5L)
timeFrame: Baseline and 24 weeks
measure: Patient Satisfaction with Care at 12 weeks
timeFrame: 12 weeks
measure: Adherence to exercise and physical activity plan at 12 weeks
timeFrame: 12 weeks
measure: Use of health care and co-interventions for knee pain from baseline to 12 weeks
timeFrame: 12 weeks
measure: Use of health care and co-interventions for knee pain from 12 to 24 weeks
timeFrame: 24 weeks
measure: Change in pain medication from baseline to 12 weeks
timeFrame: 12 weeks
Other outcomes:
measure: Feasibility of the intervention as rated by patient participants at 12 weeks using the Feasibility of Intervention Measure (FIM)
timeFrame: 12 weeks
measure: Feasibility of the intervention with clinician (physiotherapist and GP) participants as measured using the Feasibility of Intervention Measure (FIM)
timeFrame: 12 weeks
measure: The acceptability of the intervention to patient participants will be measured at 12 weeks using the Theoretical Framework of Acceptability (TFA)
timeFrame: 12 weeks
measure: The acceptability of the intervention to HCP (physiotherapist and GP) participants will be measured at 12 weeks using the Theoretical Framework of Acceptability (TFA)
timeFrame: 12 weeks
measure: Fidelity of delivery and receipt of the KNEE-DEeP GP 'enhanced consultation' will be assessed by a checklist completed by the GP (fidelity of delivery) and patient (fidelity of receipt) at baseline (0 weeks)
timeFrame: Baseline
measure: Fidelity of delivery of the KNEE-DEeP physiotherapy 'best practice' session will be assessed by a bespoke checklist completed by the physiotherapist post-intervention delivery
timeFrame: Immediately post-intervention
measure: Qualitative data on intervention acceptability and feasibility will be collected via semi-structured interviews with patient participants
timeFrame: No fixed timepoint, qualitative data will be collected between 2 weeks and 8 weeks post intervention receipt
measure: Qualitative data on intervention acceptability and feasibility will be collected via semi-structured interviews with a sub-set of participating health care professionals (GP and physiotherapists)
timeFrame: No fixed timepoint, qualitative data will be collected from health care professionals after at least 3-month of study participation
measure: Adverse events reported to the research team will be recorded in an adverse events log throughout the duration of the study
timeFrame: Duration of the study and followup period (approx 12 months)
Locations:
city: Tralee
country: Ireland
facility: University Hospital Kerry
state: Kerry
Study officials:
affiliation: University of Limerick
name: Helen O'Leary, BSc Physio
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Limerick
name: Karen McCreesh, BSc Physio
role: STUDY_CHAIR
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