Post-operative Anxiety and Depression Among Older Adults Who Undergo Surgery for Fragility Fractures

NCT06724484 | Not Yet Recruiting

• 1 other identifier: 94213
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who present with falls and fractures can experience increased symptoms of depression and anxiety due to the trauma of falling, hospitalisation and surgery. Additionally after surgery, patients may be limited in their mobility, resulting in a loss in their independence which can lead to further feelings of frustration and helplessness. In this study we want to know how common this problem is among older people who are admitted to hospital with broken bones and subsequently receiving surgery. We will use a questionnaire called the Hospital Anxiety and Depression Scale (HADS) to explore this. We will recruit 60 patients for this study, 30 participants who received operative management and a further 30 participants who did not receive surgery for comparison. Patients who are not able to consent to the study or those who are not able to complete the questionnaire will not be recruited. We will collect routine data from the patients to provide a description of the patients that we are studying. Patients will complete the HADS questionnaire once during their hospital stay and then in 1 month's time. We will contact patients through telephone for the 1 month follow up. This study will enable us to determine how common are the symptoms of anxiety and depression among this group of patients. This will help raise awareness of the problem which may prompt further intervention and management plan to address this important issue.

Conditions

Fractures in the Elderly

Keywords

Fragility fracture; Anxiety; Depression; Surgery

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale

  This will be measured at baseline and at 1 month follow up.

Study Arms (2)

Fragility fracture receiving surgery

In this group, patients who sustain a fragility fracture and receive surgical intervention will be recruited.

Procedure: Surgical management of fracture

Control

In this group, patients who sustain fragility fracture and receive conservative (non-surgical) management will be recruited.

Other: No intervention

Interventions

Surgical management of fracture PROCEDURE

Surgical management of fracture

Fragility fracture receiving surgery

No intervention OTHER

No intervention

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults who are admitted to a tertiary hospital/ major trauma centre with a fragility fracture.

You may qualify if:

• Age 65 years and above
• Received operative or non-operative management of fragility fracture
• Able to provide written consent

You may not qualify if:

• Patients receiving end of life care
• Patients with known diagnosis of severe dementia and/ or lack capacity to consent
• Non-fragility fracture

Sponsors & Collaborators

• University of Southampton: lead

Study Sites (1)

Academic Geriatric Medicine, University of Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Frenkel WJ, Jongerius EJ, Mandjes-van Uitert MJ, van Munster BC, de Rooij SE. Validation of the Charlson Comorbidity Index in acutely hospitalized elderly adults: a prospective cohort study. J Am Geriatr Soc. 2014 Feb;62(2):342-6. doi: 10.1111/jgs.12635. Epub 2014 Jan 21.

  PMID: 24521366 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Stephen Lim, BM, MRCP (UK), PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Lim, BM, MRCP (UK), PhD

CONTACT

442381206130; s.e.lim@soton.ac.uk

Samantha Meredith

CONTACT

s.j.meredith@soton.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Start date: September 2024 End date: August 2033
• Access Criteria: Anyone who is interested in the study may be able to access the data by contacting the study PI.

Locations

GB (1)