Clinical trial NCT03379623: ESCAPE-pain Programme in Malaysia
Official title: A Feasibility Randomised Controlled Trial of the Implementation in Malaysian Healthcare Context of the ESCAPE-pain Programme for Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall aim of this study is to develop an evidence based exercise programme for the management of knee osteoarthritis which is feasible and acceptable to patients and healthcare professionals in Malaysia. The chosen programme was identified through a systematic literature search and is the programme developed by Hurley et al. in 2007. This programme will be evaluated through mixed-methods sequential exploratory design research study guided by the United Kingdom (UK) Medical Research Council guidance and framework. It involves two phases of data collection. The first phase (already completed) comprised a qualitative study aimed at exploring the beliefs and attitudes of Malaysian people that would need to be taken into account when adapting the evidence based ESCAPE-pain (acronym for 'Enabling Self-management and Coping with Arthritic pain using Exercise) programme for implementation in the context of Malaysian healthcare system. The second phase will be conducted to evaluate the feasibility of trialling ESCAPE-pain programme in Malaysia.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 and 12 weeks
timeFrame: Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
Secondary outcomes:
measure: Change of Baseline Timed up and Go Test at 6 and 12 weeks
timeFrame: Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
measure: Change of Baseline Health Beliefs and Self-efficacy for exercise at 6 and 12 weeks
timeFrame: Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
measure: Change of Baseline The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) at 6 and 12 weeks
timeFrame: Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
measure: Change of Baseline Short Falls Efficacy Scale-International (FES-I) at 6 and 12 weeks
timeFrame: Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
measure: Exercise Adherence Rating Scale (EARS)
timeFrame: Week 12 of intervention
Other outcomes:
Locations:
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
state: Pahang
city: Kuantan
country: Malaysia
facility: IIUM Medical Centre
state: Pahang
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.