Ignite Creation Date:
2024-05-06 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03379623
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2017-11-28
Brief Title:
ESCAPE-pain Programme in Malaysia
Sponsor:
Muhammad Kamil Che Hasan
Organization:
University of Manchester
Study Overview
Official Title:
A Feasibility Randomised Controlled Trial of the Implementation in Malaysian Healthcare Context of the ESCAPE-pain Programme for Patients With Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 researchers 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None