ESCAPE-pain Programme in Malaysia
A Feasibility Randomised Controlled Trial of the Implementation in Malaysian Healthcare Context of the ESCAPE-pain Programme for Patients With Knee Osteoarthritis
研究概览
详细说明
In Malaysia, functional limitations and impaired daily living activities affect patients with knee osteoarthritis (OA) in such a way that they tend to refrain from hospital visits. This may may lead to depression and reduced quality of life, which may then impact on increases in health care costs. The service provided by hospitals to these patients, is under-utilised by the multi-ethnic people that make up the population. Through the researcher's previous clinical experience, it was observed that patients were complaining of difficulty in getting to the hospital, long waiting times, and also increasing transport costs. Thus, adoption of self-care and early prevention has been suggested as a solution for the OA affected Malaysian community. In addition, there is no home based exercise programme for patients with knee OA in current health practice in Malaysia. Although some of these patients in Malaysia are prescribed with home-based exercises, a fully comprehensive self-management programme is lacking for patients generally. Therefore, there is a need for a home based self-management exercise programme for people with knee OA which can be implemented in community setting without frequent involvement of the hospitals. The UK Medical Research Council Guidance and Framework on developing and evaluating complex interventions will be used to facilitate the process of developing a complex intervention. A systematic review of the literature identified an exercise programme called ESCAPE-Pain as the programme with the best evidence for adaptation as a self-management programme to implement in Malaysia.
In phase 1, (already conducted), the investigators have undertaken interviews with patients and healthcare professionals (HCPs) in Malaysia to identify their beliefs and attitudes towards the ESCAPE-pain programme. Preliminary analysis reveals that patients with knee OA and HCPs have positive views towards the implementation of the programme with integration of a few new components.
In this phase, the investigators propose to undertake a feasibility randomised controlled trial in which the investigators compare the modified ESCAPE-pain programme for the Malaysian context, versus usual care in Malaysian OA patients. ESCAPE-pain is a rehabilitation programme that helps people with osteoarthritis (OA) and/or chronic joint pain to self -manage their condition. The programme aims to increase physical function and improve quality of life. The ESCAPE-pain programme, will be run over six weeks, with participants attending for one hour session, twice a week. Each session contains around a 20 minutes themed discussion focused on helping to support self-management and followed by about 45 minutes of exercise. The sessions will be led by the researcher who trained in how to deliver the ESCAPE-pain programme.
This feasibility study is required to identify the best methods for a definitive trial in the future, to test recruitment and other trial procedures, the acceptability of the intervention and the way it is implemented and to provide insight into appropriateness of our outcome measures, including providing data to permit estimation of effect size to be used in sample size calculations for a definitive trial.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Pahang
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Kuantan、Pahang、马来西亚、25100
- Hospital Tengku Ampuan Afzan
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Kuantan、Pahang、马来西亚、25200
- IIUM Medical Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 50 years or older (one of the criteria to diagnose knee osteoarthritis by a medical officer based on Ministry of Health Malaysia guidelines (MoH, 2014)).
- Diagnosed with osteoarthritis affecting the knee by medical officer based on Clinical Practice Guidelines (CPG) MOH (MOH, 2014).
- Independently mobile either with or without walking aid.
- Approved medically fit for exercise by a medical officer.
- Able to communicate in Malay language.
- Must have mental capacity to give informed consent.
Exclusion Criteria:
- Had knee replacement / lower limb arthroplasty.
- Intraarticular injections within past six months.
- Have any significant musculoskeletal issues (e.g. inflammatory arthritis, connective tissue diseases, fibromyalgia, severe osteoporosis, peripheral neuropathy, or gout).
- Very severe joint pain which limiting mobility to less than 50 metres.
- people with unstable co-morbidities (such as cardiovascular and respiratory conditions, type 2 diabetes, severe pain in other joints).
- wheelchair user.
- severe cognitive impairment assessed by a medical officer.
- severe auditory or visual impairment assessed by a medical officer.
- inability to comprehend the ESCAPE-pain procedure
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：干预组
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The Enabling Self-management and Coping with Arthritic (knee) Pain using Exercise (ESCAPE-pain) is a programme of rehabilitation that integrates educational self-management and coping strategies for people with joint pain with an individualised exercise regimen for each participant.
The implementation of the programme will be conducted by the researcher as a certified facilitator by using Clinician's training manual for the ESCAPE-pain programme.
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无干预：常规护理组
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 and 12 weeks
大体时间：Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
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The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems.
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL).
The previous week is the time period considered when answering the questions.
Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
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Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change of Baseline Timed up and Go Test at 6 and 12 weeks
大体时间：Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
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The purpose is to measure lower limb strength and balance while moving.
A chair will be placed next to a wall and the marker 8 feet will be marked with a cone in front of the chair.
The path between the chair and the marker will be cleared from any obstacle.
The participant will be started with fully seated with hands resting on the knees and feet flat on the ground.
On the command, "Go," timing will be started and the subject stands and walks (no running) as quickly as possible (and safely) to and around the cone, returning to the chair to sit down.
The time will be stopped as they sit down.
It will be performed two trials.
Participants will be given a chance to do practice trial before actual time measured.
The average time will be recorded to the nearest 1/10th second.
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Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
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Change of Baseline Health Beliefs and Self-efficacy for exercise at 6 and 12 weeks
大体时间：Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
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A simple outcome measure that captures the benefit people attain from exercise.
It is by altering their ability to exercise effectively and their beliefs towards exercise.A 17-items questionnaires to reflect the beliefs about one's ability to exercise (self-efficacy for exercise) (4 items), barriers to exercise (3 items), benefits of exercise (3 items), and impact of exercise on arthritis (7 items).
The items use a 5-point Likert scale, ranging from strongly agree to strongly disagree, to indicate their beliefs.
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Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
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Change of Baseline The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) at 6 and 12 weeks
大体时间：Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
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SWEMWBS is used in the context of projects and programmes to enable self-reflection as a prelude to involvement with health enhancing activities.
It does seem to be sensitive to changes in mental wellbeing at the individual level.
Each of the 7 statement responses in SWEMWBS are scored from 1 to 5, from 'none of the time' to 'all of the time'.
A total score is calculated by summing the 7 individual statement scores.
The minimum score is 7 and the maximum is 35.
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Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
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Change of Baseline Short Falls Efficacy Scale-International (FES-I) at 6 and 12 weeks
大体时间：Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
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The short Falls Efficacy Scale-International (FES-I) is a validated and reliable 7-item tool which measures confidence in performing a range of activities of daily living without falling.
This scale has recently been modified to maximise its suitability for a range of different languages and cultures (Yardley et al. 2005).
Participants will be asked to rate, on a four-point Likert scale,their concerns about the possibility of falling when performing 7 activities.
Participants will be instructed to rate each activity regardless of whether they actually perform it.
The scores are added up to calculate a total score that ranges from 7 to 28 for the short FES-I.
A higher score indicates a greater fear of falling.
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Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
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Exercise Adherence Rating Scale (EARS)
大体时间：Week 12 of intervention
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Exercise Adherence Rating Scale (EARS) is an assessment measuring tool to assess adherence to prescribed home exercise.
It consists of 6 statements that best describes how participants do their recommended exercises/activities.
The EARS is scored on a 5-point Likert scale (0 - completely agree to 4 - completely disagree).
Items 1, 4 and 6 are reverse scored, resulting in a possible score of between 0 and 24.
A higher score indicates better adherence.
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Week 12 of intervention
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合作者和调查者
出版物和有用的链接
一般刊物
- Stewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15.
- Hurley MV, Walsh NE, Mitchell HL, Pimm TJ, Patel A, Williamson E, Jones RH, Dieppe PA, Reeves BC. Clinical effectiveness of a rehabilitation program integrating exercise, self-management, and active coping strategies for chronic knee pain: a cluster randomized trial. Arthritis Rheum. 2007 Oct 15;57(7):1211-9. doi: 10.1002/art.22995.
- Newman-Beinart NA, Norton S, Dowling D, Gavriloff D, Vari C, Weinman JA, Godfrey EL. The development and initial psychometric evaluation of a measure assessing adherence to prescribed exercise: the Exercise Adherence Rating Scale (EARS). Physiotherapy. 2017 Jun;103(2):180-185. doi: 10.1016/j.physio.2016.11.001. Epub 2016 Nov 9.
- Hurley MV, Walsh NE, Mitchell HL, Pimm TJ, Williamson E, Jones RH, Reeves BC, Dieppe PA, Patel A. Economic evaluation of a rehabilitation program integrating exercise, self-management, and active coping strategies for chronic knee pain. Arthritis Rheum. 2007 Oct 15;57(7):1220-9. doi: 10.1002/art.23011.
- Jessep SA, Walsh NE, Ratcliffe J, Hurley MV. Long-term clinical benefits and costs of an integrated rehabilitation programme compared with outpatient physiotherapy for chronic knee pain. Physiotherapy. 2009 Jun;95(2):94-102. doi: 10.1016/j.physio.2009.01.005. Epub 2009 Mar 21.
- Hauer KA, Kempen GI, Schwenk M, Yardley L, Beyer N, Todd C, Oster P, Zijlstra GA. Validity and sensitivity to change of the falls efficacy scales international to assess fear of falling in older adults with and without cognitive impairment. Gerontology. 2011;57(5):462-72. doi: 10.1159/000320054. Epub 2010 Oct 22.
- Zulkifli MM, Kadir AA, Elias A, Bea KC, Sadagatullah AN. Psychometric Properties of the Malay Language Version of Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire among Knee Osteoarthritis Patients: A Confirmatory Factor Analysis. Malays Orthop J. 2017 Jul;11(2):7-14. doi: 10.5704/MOJ.1707.003.
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学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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