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

NCT05829096 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-08-09

No results posted yet for this study

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

Interventions

OTHER

The COMBINED approach

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

Sponsors & Collaborators

  • Manchester Metropolitan University

    collaborator OTHER

  • Julie Bury

    lead OTHER

Principal Investigators

  • Julie Bury · Manchester Metropolitan University

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-03
Primary Completion
2023-10-25
Completion
2023-10-25

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05829096 on ClinicalTrials.gov