Knowledge Translation and Exercise for Degenerative Meniscal Tears and Early Osteoarthritis: the KNEE-DEeP Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in physical function from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS)
研究概览
简要总结
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.
详细描述
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:
- Determine the acceptability of the intervention content and delivery to HCPs and patients
- Determine adherence of GPs and physiotherapists to study processes around intervention delivery to patients
- Assess fidelity related to intervention delivery and intervention receipt, from the perspectives of HCPs and patients.
- Determine if data collection procedures and outcome measures are feasible and acceptable to HCPs and patients
- Determine feasibility of HCP and patients' recruitment and retention procedures
- Investigate the magnitude of change and variability in the clinical outcome measures
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
结局指标
主要结局
Change in physical function from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS)
时间窗: Baseline and 12 weeks
This 7-item measure of physical function is derived from the activities of daily living and sport/recreation subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS). Psychometric testing shows the KOOS-PS to be valid and reliable for use in groups with knee OA, making it an suitable tool for measuring knee-related function in this research. Scores range from 0 (extreme problems) to 100 (no problems).
次要结局
- Change in knee pain from baseline to 24 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Pain Subscale(Baseline and 24 weeks)
- Change in fear avoidance beliefs from baseline to 12 weeks as measured by the physical activity subscale of the Fear Avoidance Belief Questionnaire (FABQ)(Baseline and 12 weeks)
- Change in pain self-efficacy from baseline to 24 weeks as measured by the Pain Self-efficacy (PSEQ 2-item short form)(Baseline and 24 weeks)
- Change in physical function from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS)(Baseline and 24 weeks)
- Adherence to exercise and physical activity plan at 12 weeks(12 weeks)
- Use of health care and co-interventions for knee pain from baseline to 12 weeks(12 weeks)
- Patient Satisfaction with Care at 12 weeks(12 weeks)
- Change in pain self-efficacy from baseline to 12 weeks as measured by the Pain Self-efficacy (PSEQ 2-item short form)(Baseline and 12 weeks)
- Change in fear avoidance beliefs from baseline to 24 weeks as measured by the physical activity subscale of the Fear Avoidance Belief Questionnaire (FABQ)(Baseline and 24 weeks)
- Change in pain medication from baseline to 12 weeks(12 weeks)
- Change in knee pain from baseline to 12 weeks as measured by Knee Injury and Osteoarthritis Outcome Score Pain Subscale(Baseline and 12 weeks)
- Use of health care and co-interventions for knee pain from 12 to 24 weeks(24 weeks)
- Change in health related quality of life from baseline to 12 weeks as measured by the EuroQol Five-Dimensional Questionnaire (EQ-5D-5L)(Baseline and 12 weeks)
- Change in health related quality of life from baseline to 24 weeks as measured by the EuroQol Five-Dimensional Questionnaire (EQ-5D-5L)(Baseline and 24 weeks)