Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05829096
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2023-03-21
Brief Title:
The COMBINED Study to Integrate Health Behaviour Change for People With a Rotator Cuff Disorder
Sponsor:
Julie Bury
Organization:
Manchester Metropolitan University
Study Overview
Official Title:
COmbining Brief Interventions for Modifiable Health Behaviours withIN a Physiotherapy Consultation for pEople With a Rotator Cuff Disorder Development and Testing in a Single-arm Feasibility Study
Status:
COMPLETED
Status Verified Date:
2024-08
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:
COMBINED
Brief Summary:
COMBINED is a pragmatic single-arm feasibility study The goal of this study is to evaluate the implementation of a physiotherapy-led intervention The COMBINED approach to facilitate ongoing refinements including the strategies for implementation in readiness for a definitive trial in people with a rotator cuff disorder The main questions it aims to answer are 1 What are the key domains of behaviour change influencing the implementation of The COMBINED approach among physiotherapists 2 Can The COMBINED approach be delivered as intended 3 Are there any refinements required to the intervention components 4 What is the patient experience of receiving The COMBINED approach in an NHS setting
Detailed Description:
The COMBINED study is looking at how current treatments can be improved for people with shoulder pain who have been diagnosed with a rotator cuff RC disorder The RC is a group of muscles and tendons which move and stabilise the shoulder joint and problems with these muscles and tendons can result in pain and difficulty doing everyday tasks
Current treatments for RC disorders offer only small to moderate benefits and long-term outcomes can be poor Lifestyle factors including smoking being overweight and physical inactivity are associated with the onset and persistence of RC disorders These factors are linked to modifiable health behaviours that if patients are supported to change might help improve their shoulder pain Despite this evidence physiotherapists do not routinely integrate health behaviour change approaches as part of the management for RC disorders
The investigators have designed and tested a new complex intervention The COMBINED approach that aims to help patients improve their shoulder pain by identifying and assessing the lifestyle factors associated with the onset and persistence of a RC disorder and where appropriate the delivery of a brief behaviour change intervention to address these as part of a management plan supported by a physiotherapist The investigators have also developed an implementation toolkit to enable and support physiotherapists to effectively deliver this approach in clinical practice This has been tested and refined in a small usability study which has led to an optimised version of The COMBINED approach The investigators would like to find out if this treatment approach can now be delivered within the NHS and to improve this further before testing it in a definitive randomised controlled trial The overall aim is to provide better care for people with a RC disorder
This will be a non-randomised feasibility study with qualitative interviews The study will be conducted in physiotherapy musculoskeletal services across four NHS sites and expected to last 4-6 months Chartered physiotherapists working at one of the musculoskeletal physiotherapy services and patients diagnosed with a RC disorder will be eligible to take part
Physiotherapist participants would be expected to attend a training workshop deliver the new treatment approach to patients and complete a survey Patient participants would be asked to attend up to two treatment sessions for their shoulder pain 60 mins each with a qualified physiotherapist During this treatment session they will be asked some questions about their shoulder pain and other things that could be influencing their shoulder pain such as if they smoke their weight and how active they are Where applicable the physiotherapist may also measure their height and weight during the consultation The participants will have an examination of their shoulder Different treatment options will then be discussed This will be very similar to what participants would expect in a normal physiotherapy appointment The treatment sessions will be audio-recorded with consent for the purpose of checking what information and treatment was delivered by the physiotherapist in the session The lead researcher may also request with consent to observe one of the treatment sessions The purpose of this is to identify ways to improve how physiotherapists deliver the new treatment approach
A selection of patients will be asked to take part in an optional short up to 20 minutes telephone interview about their views and experience of the treatment session
Current treatments for RC disorders offer only small to moderate benefits and long-term outcomes can be poor Lifestyle factors including smoking being overweight and physical inactivity are associated with the onset and persistence of RC disorders These factors are linked to modifiable health behaviours that if patients are supported to change might help improve their shoulder pain Despite this evidence physiotherapists do not routinely integrate health behaviour change approaches as part of the management for RC disorders
The investigators have designed and tested a new complex intervention The COMBINED approach that aims to help patients improve their shoulder pain by identifying and assessing the lifestyle factors associated with the onset and persistence of a RC disorder and where appropriate the delivery of a brief behaviour change intervention to address these as part of a management plan supported by a physiotherapist The investigators have also developed an implementation toolkit to enable and support physiotherapists to effectively deliver this approach in clinical practice This has been tested and refined in a small usability study which has led to an optimised version of The COMBINED approach The investigators would like to find out if this treatment approach can now be delivered within the NHS and to improve this further before testing it in a definitive randomised controlled trial The overall aim is to provide better care for people with a RC disorder
This will be a non-randomised feasibility study with qualitative interviews The study will be conducted in physiotherapy musculoskeletal services across four NHS sites and expected to last 4-6 months Chartered physiotherapists working at one of the musculoskeletal physiotherapy services and patients diagnosed with a RC disorder will be eligible to take part
Physiotherapist participants would be expected to attend a training workshop deliver the new treatment approach to patients and complete a survey Patient participants would be asked to attend up to two treatment sessions for their shoulder pain 60 mins each with a qualified physiotherapist During this treatment session they will be asked some questions about their shoulder pain and other things that could be influencing their shoulder pain such as if they smoke their weight and how active they are Where applicable the physiotherapist may also measure their height and weight during the consultation The participants will have an examination of their shoulder Different treatment options will then be discussed This will be very similar to what participants would expect in a normal physiotherapy appointment The treatment sessions will be audio-recorded with consent for the purpose of checking what information and treatment was delivered by the physiotherapist in the session The lead researcher may also request with consent to observe one of the treatment sessions The purpose of this is to identify ways to improve how physiotherapists deliver the new treatment approach
A selection of patients will be asked to take part in an optional short up to 20 minutes telephone interview about their views and experience of the treatment session
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