NCT05905471

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2024

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

June 7, 2023

Last Update Submit

June 18, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • To explore how a shoulder fracture impact on daily life

    From approximately one to five months post injury

  • To explore patients' views on recovery at different time points throughout the recovery process.

    From approximately one to five months post injury

  • To explore the needs of patients with respect to information provision following a shoulder fracture.

    From approximately one to five months post injury

Interventions

Interview study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who have sustained a shoulder fracture and live in the East Lancashire area.

You may qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Lancashire Hospitals NHS Trust

Burnley, United Kingdom

Location

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 15, 2023

Study Start

June 15, 2023

Primary Completion

March 28, 2024

Study Completion

March 28, 2024

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations