- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05905471
Shoulder Fracture Interview Study
Living With a Shoulder Fracture - An Interview Study
Shoulder fractures are painful injuries and are the third most common fracture in adults. More and more people are having these injuries each year. Problems such as pain, swelling and lack of movement and strength can last for many months and some people never get back to their previous levels of ability with the injured arm. Information that is given to people following this injury can be very difficult to understand. To improve the information that is given to people following a shoulder fracture, it is necessary to understand what it is like to live with a shoulder fracture and what is important to people recovering from this injury.
This study will interview people who have had a shoulder fracture at around one month and around 4-6 months after their injury. These people will be identified from a physiotherapy waiting list. The interviews will explore people's views on their injury, their recovery and how their needs and priorities change over time.
Study Overview
Status
Intervention / Treatment
Detailed Description
Previous studies have shown that the written information provided to people after a shoulder fracture is varied and complex, and is written by experts without any apparent input from patients. Appropriate information provided at the right time may lead to improved outcomes for patients after a shoulder fracture, which may mean improvements in pain levels and function. Appropriate information may help to increase patients empowerment, which is their ability to use information provided to enable them to make informed decisions regarding their health care and to take a proactive approach in their recovery following an injury such as a shoulder fracture. To ensure that information is accessible and appropriate, it is necessary to understand the experience of living with a shoulder fracture and what is important to those who have sustained this injury.
This study intends to hear the views of people who have had a shoulder fracture both early on (around one month after injury) and later in their recovery (4-6 months after injury). It aims to explore the differing needs and experiences of people at different time points after injury and how their views on recovery change over time.
This may lead to further work on information provision, which may help improve outcomes by providing the right (accessible) information to the right people in the right way at the right time.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Burnley, United Kingdom
- East Lancashire Hospitals NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18 years or over
Have sustained a proximal humerus fracture and been referred from East Lancashire Hospitals NHS Trust fracture clinic to outpatient physiotherapy
Able and willing to provide written informed consent, as deemed by the Chief Investigator
Exclusion Criteria:
- Does not meet inclusion criteria
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To explore how a shoulder fracture impact on daily life
Time Frame: From approximately one to five months post injury
|
From approximately one to five months post injury
|
|
To explore patients' views on recovery at different time points throughout the recovery process.
Time Frame: From approximately one to five months post injury
|
From approximately one to five months post injury
|
|
To explore the needs of patients with respect to information provision following a shoulder fracture.
Time Frame: From approximately one to five months post injury
|
From approximately one to five months post injury
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEV033
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.