ESCAPE-pain Programme in Malaysia

Knee Osteoarthritis Clinical Trial

Official title:

A Feasibility Randomised Controlled Trial of the Implementation in Malaysian Healthcare Context of the ESCAPE-pain Programme for Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379623
• Other study ID #: 2017-2045-3627
• Status: Completed
• Phase: N/A
• Start date: October 12, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: May 2018
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 28, 2018
• Est. primary completion date: January 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• ESCAPE-pain Programme
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.

Locations

Country	Name	City	State
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan	Pahang
Malaysia	IIUM Medical Centre	Kuantan	Pahang

Sponsors (1)

Lead Sponsor	Collaborator
Muhammad Kamil Che Hasan

Country where clinical trial is conducted

Malaysia, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 and 12 weeks	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.	Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
Secondary	Change of Baseline Timed up and Go Test at 6 and 12 weeks	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.	Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
Secondary	Change of Baseline Health Beliefs and Self-efficacy for exercise at 6 and 12 weeks	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.	Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
Secondary	Change of Baseline The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) at 6 and 12 weeks	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.	Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
Secondary	Change of Baseline Short Falls Efficacy Scale-International (FES-I) at 6 and 12 weeks	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.	Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.
Secondary	Exercise Adherence Rating Scale (EARS)	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.	Week 12 of intervention