Proximal Humerus Fracture (Shoulder Fracture)NCT05905471
Shoulder Fracture Interview Study
An observational study of Proximal Humerus Fracture (Shoulder Fracture), run by East Lancashire Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Proximal Humerus Fracture (Shoulder Fracture)
- What is being tested?
- Interview
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2023to 28 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who have sustained a shoulder fracture and live in the East Lancashire area.
Who may be able to join
- 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
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Interview
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Interview study
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore how a shoulder fracture impact on daily life
Measured: From approximately one to five months post injury
To explore patients' views on recovery at different time points throughout the recovery process.
Measured: From approximately one to five months post injury
To explore the needs of patients with respect to information provision following a shoulder fracture.
Measured: From approximately one to five months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Jun 2023
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humerus Fracture (Shoulder Fracture)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Lancashire Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pauline May, East Lancashire Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905471
- Sponsor's protocol ID
- DEV033
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living With a Shoulder Fracture - An Interview Study
- ClinicalTrials.gov ID
- NCT05905471
- Acronym / sponsor ID
- DEV033
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- East Lancashire Hospitals NHS TrustUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have sustained a shoulder fracture and live in the East Lancashire area.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewInterview study | Other | – |
Primary outcome
To explore how a shoulder fracture impact on daily life
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humerus Fracture (Shoulder Fracture), run by East Lancashire Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore how a shoulder fracture impact on daily life (time frame: From approximately one to five months post injury). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.