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

NCT05829096 | Completed

• 1 other identifier: 51451
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

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?

Conditions

Physiotherapy; Rotator Cuff Syndrome; Rotator Cuff Impingement Syndrome

Keywords

Rotator cuff; Physiotherapy; Shoulder pain; Lifestyle

Outcome Measures

Primary Outcomes (3)

• To assess a change in the Determinants of Behavior Questionnaire (DIBQ)

  Physiotherapy self-report survey

  At baseline (0 months) and study completion (expected at 6 months)

• Fidelity of intervention delivery (self-report checklist by the physiotherapists) will be reported descriptively

  What intervention components were delivered by the physiotherapists as intended

  6 months

• 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

  6 months

Secondary Outcomes (1)

• Number of patients recruited that have one or more of the identified lifestyle factor will be reported descriptively

  6 months

Study Arms (1)

Intervention arm

EXPERIMENTAL

This is a single arm interventional study. 1. 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. 2. 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.

Other: The COMBINED approach

Interventions

The COMBINED approach OTHER

1. 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. 2. 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

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Julie Bury: lead
• Manchester Metropolitan University: collaborator

Study Sites (4)

University Hospitals of Leicester

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Doncaster and Bassetlaw NHS Foundation Trust

Doncaster, South Yorkshire, DN2 5LT, United Kingdom

Location

Calderdale and Huddersfield NHS Foundation Trsut

Halifax, West Yorkshire, HX3 0PW, United Kingdom

Location

Airedale Foundation Trust

Keighley, West Yorkshire, BD20 6TD, United Kingdom

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Bury

  Manchester Metropolitan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: N/A, study does not involve pharmaceutical products or medical devices. There is no randomisation involved in this study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: HEE/NIHR Clinical Doctoral Research Fellow

Model Details: Single arm feasibility study

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 25, 2023
• Study Start: July 3, 2023
• Primary Completion: October 25, 2023
• Study Completion: October 25, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)