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

May 14, 2026 updated by: University of Southampton

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 the investigators want to know how common this problem is among older people who are admitted to hospital with broken bones and subsequently receiving surgery.

The investigators 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. The investigators will collect routine data from the patients to provide a description of the patients. Patients will complete the HADS questionnaire once during their hospital stay and then in 1 month's time. The investigators will contact patients through telephone for the 1 month follow up.

This study will enable the investigators 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Academic Geriatric Medicine, University of Southampton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale
Time Frame: This will be measured at baseline and at 1 month follow up.
The Hospital Anxiety and Depression scale (HADS) consists of 14 items split into two 7-item subscales for anxiety (HADS-A) and depression (HADS-D), each scored 0-3, with subscale totals ranging from 0 to 21; scores of 0-7 are normal, 8-10 borderline, and 11-21 indicating an abnormal score that will trigger further clinical assessment for anxiety and/or depression.
This will be measured at baseline and at 1 month follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southampton

Investigators

  • Principal Investigator: Stephen Lim, BM, MRCP (UK), PhD, University of Southampton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 94213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised data will be made available on the university's online repository.

IPD Sharing Time Frame

Start date: September 2024 End date: August 2033

IPD Sharing Access Criteria

Anyone who is interested in the study may be able to access the data by contacting the study PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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