search
Back to results

The COMBINED Study to Integrate Health Behaviour Change for People With a Rotator Cuff Disorder (COMBINED)

Primary Purpose

Physiotherapy, Rotator Cuff Syndrome, Rotator Cuff Impingement Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The COMBINED approach
Sponsored by
Julie Bury
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Physiotherapy focused on measuring Rotator cuff, Physiotherapy, Shoulder pain, Lifestyle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The inclusion criteria for the clinician participants are: A qualified (HCPC registered) physiotherapist involved in the management of patients with a RC disorder at one of the trial sites; Willing to consent to the study procedures, including attending a training workshop, audio-recording of the consultations and audit/feedback on intervention delivery. The inclusion criteria for patient participants are: Adult (aged 18 or over); Diagnosed with a RC disorder as per the diagnostic criteria in the British Elbow and Shoulder Society guidelines (Kulkarni et al., 2015), which includes pain mid-range on abduction movement, pain on resisted tests and no loss of external rotation, along with screening of the neck and ruling out other conditions (e.g., instability/frozen shoulder). This will be confirmed by the site Principal Investigators (PI), specialist HCPC registered physiotherapists; Able to attend at least one face-to-face physiotherapy consultation. Eligibility will be confirmed via physical examination at this session as per the criteria above; Able to give full informed consent; Willing to consent to the study procedures, including audio-recording of the consultations. Exclusion Criteria: The exclusion criteria for the patient participants are: Significant trauma; Neurological or inflammatory causes of their shoulder pain; Any clinical indications of serious pathology. We will not exclude anyone based upon protected characteristics for example, age and ethnicity. Anyone referred into the physiotherapy department with a RC disorder will be eligible to take part in the study. Measures in place may include support for the consent process, consultation or patient interviews where required, for example, if verbal translation is needed via a hospital interpreter, personal interpreter or telephone translation service.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention arm

    Arm Description

    This is a single arm interventional study. A patient-level intervention, which includes: An assessment of existing lifestyle factors (smoking status, physical activity levels, and weight) that may be relevant to shoulder pain; A brief intervention to support health behaviour change with respect to the target behaviours of smoking cessation, increasing physical activity levels and consuming a healthy diet Supporting tools for behaviour change, including an activity workbook for goal-setting and a diary for self-monitoring (attached). The intervention is to be delivered by physiotherapists, integrated within a routine consultation for people with a RC disorder. A clinician-level implementation toolkit to support the delivery of the clinical intervention, which includes a training package and additional resources e.g. scripts to aid conversations with patients.

    Outcomes

    Primary Outcome Measures

    To assess a change in the Determinants of Behavior Questionnaire (DIBQ)
    Physiotherapy self-report survey
    Fidelity of intervention delivery (self-report checklist by the physiotherapists) will be reported descriptively
    What intervention components were delivered by the physiotherapists as intended
    Fidelity of intervention delivery (observed through audio-recordings by the research team) will be reported descriptively
    What intervention components were delivered by the physiotherapists as intended

    Secondary Outcome Measures

    Number of patients recruited that have one or more of the identified lifestyle factor will be reported descriptively
    Identified lifestyle factors include: Smoker; BMI >25kg/m2; physical activity levels <150/minutes of moderate intensity/week

    Full Information

    First Posted
    March 21, 2023
    Last Updated
    April 24, 2023
    Sponsor
    Julie Bury
    Collaborators
    Manchester Metropolitan University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05829096
    Brief Title
    The COMBINED Study to Integrate Health Behaviour Change for People With a Rotator Cuff Disorder
    Acronym
    COMBINED
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    November 20, 2023 (Anticipated)
    Study Completion Date
    November 20, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Julie Bury
    Collaborators
    Manchester Metropolitan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Physiotherapy, Rotator Cuff Syndrome, Rotator Cuff Impingement Syndrome
    Keywords
    Rotator cuff, Physiotherapy, Shoulder pain, Lifestyle

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single arm feasibility study
    Masking
    None (Open Label)
    Masking Description
    N/A, study does not involve pharmaceutical products or medical devices. There is no randomisation involved in this study.
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention arm
    Arm Type
    Experimental
    Arm Description
    This is a single arm interventional study. A patient-level intervention, which includes: An assessment of existing lifestyle factors (smoking status, physical activity levels, and weight) that may be relevant to shoulder pain; A brief intervention to support health behaviour change with respect to the target behaviours of smoking cessation, increasing physical activity levels and consuming a healthy diet Supporting tools for behaviour change, including an activity workbook for goal-setting and a diary for self-monitoring (attached). The intervention is to be delivered by physiotherapists, integrated within a routine consultation for people with a RC disorder. A clinician-level implementation toolkit to support the delivery of the clinical intervention, which includes a training package and additional resources e.g. scripts to aid conversations with patients.
    Intervention Type
    Other
    Intervention Name(s)
    The COMBINED approach
    Intervention Description
    Patient-level intervention: Assessment of existing lifestyle factors (smoking status, physical activity levels, and weight) that may be relevant to shoulder pain; Brief intervention to support health behaviour change: smoking cessation, increasing physical activity levels and consuming a healthy diet Supporting tools for behaviour change, including an activity workbook for goal-setting and a diary for self-monitoring. Clinician-level implementation toolkit: Training package including a face-to-face workshop, training manual, recorded role play simulations and an online follow-up training session Additional supporting resources; a step-by-step guide to The COMBINED approach, scripts, patient signposting information to support services and a lay summary infographic to explain the links between the health behaviours and RC disorders to patients Audit and feedback via observations of consultations to address any 'drift' from the intervention delivery as intended
    Primary Outcome Measure Information:
    Title
    To assess a change in the Determinants of Behavior Questionnaire (DIBQ)
    Description
    Physiotherapy self-report survey
    Time Frame
    At baseline (0 months) and study completion (expected at 6 months)
    Title
    Fidelity of intervention delivery (self-report checklist by the physiotherapists) will be reported descriptively
    Description
    What intervention components were delivered by the physiotherapists as intended
    Time Frame
    6 months
    Title
    Fidelity of intervention delivery (observed through audio-recordings by the research team) will be reported descriptively
    Description
    What intervention components were delivered by the physiotherapists as intended
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Number of patients recruited that have one or more of the identified lifestyle factor will be reported descriptively
    Description
    Identified lifestyle factors include: Smoker; BMI >25kg/m2; physical activity levels <150/minutes of moderate intensity/week
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The inclusion criteria for the clinician participants are: A qualified (HCPC registered) physiotherapist involved in the management of patients with a RC disorder at one of the trial sites; Willing to consent to the study procedures, including attending a training workshop, audio-recording of the consultations and audit/feedback on intervention delivery. The inclusion criteria for patient participants are: Adult (aged 18 or over); Diagnosed with a RC disorder as per the diagnostic criteria in the British Elbow and Shoulder Society guidelines (Kulkarni et al., 2015), which includes pain mid-range on abduction movement, pain on resisted tests and no loss of external rotation, along with screening of the neck and ruling out other conditions (e.g., instability/frozen shoulder). This will be confirmed by the site Principal Investigators (PI), specialist HCPC registered physiotherapists; Able to attend at least one face-to-face physiotherapy consultation. Eligibility will be confirmed via physical examination at this session as per the criteria above; Able to give full informed consent; Willing to consent to the study procedures, including audio-recording of the consultations. Exclusion Criteria: The exclusion criteria for the patient participants are: Significant trauma; Neurological or inflammatory causes of their shoulder pain; Any clinical indications of serious pathology. We will not exclude anyone based upon protected characteristics for example, age and ethnicity. Anyone referred into the physiotherapy department with a RC disorder will be eligible to take part in the study. Measures in place may include support for the consent process, consultation or patient interviews where required, for example, if verbal translation is needed via a hospital interpreter, personal interpreter or telephone translation service.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julie Bury
    Phone
    +441302 644069
    Email
    julie.bury@stu.mmu.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ramona Statache
    Phone
    +44161 2472000
    Email
    ethics@mmu.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julie Bury
    Organizational Affiliation
    Manchester Metropolitan University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Individual participant data will not be available to other researchers

    Learn more about this trial

    The COMBINED Study to Integrate Health Behaviour Change for People With a Rotator Cuff Disorder

    We'll reach out to this number within 24 hrs