Symptoms of Anxiety and/or Depression and SDM in Older Patients With CLTI

NCT07529886 | Not Yet Recruiting

• 1 other identifier: 361194
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Mental health disorders are common in older people and are often unrecognised. Those living with mental health disorders who are being considered for vascular surgery have worse post operative outcomes, including longer length of hospital stay, higher readmission rates and emergency admissions to hospital. These patients also have more medical conditions contributing to their post surgery complications and poor health outcomes. Surgery for vascular patients can include life changing operations, such as amputation, which impacts mental health and quality of life. Shared decision making is the process whereby patients and clinicians work together to make evidence based decisions centred on patient values and preferences and is part of the Comprehensive Geriatric Assessment and optimisation (CGA) model of care. SDM has been shown to improve patient experience through provision of realistic choice, enhanced interaction with clinicians, greater empowerment and increased confidence and trust in healthcare provision. Implementing SDM in vascular patients can be particularly challenging. Evaluating and communicating benefits and risks of available treatments for CLTI in a complex older patient population requires additional consideration beyond the inherent surgical risks. To achieve truly informed SDM, the clinician requires knowledge of the impact of co-existing conditions on postoperative recovery, the natural history of the surgical pathology with and without surgery and an awareness of the benefits and risks of alternative treatments underpinned by skilful communication.

Conditions

Critical Limb Threatening Ischaemia; Depression Disorder; Anxiety

Keywords

Shared decision making; Perioperative medicine; Geriatrics; Mental health problems; Vascular surgery

Outcome Measures

Primary Outcomes (1)

• Anxiety and/or depression during the SDM process via semi structured interview

  Semi structured interviews will be qualitatively analysed via thematic analysis.

  6 months

Study Arms (1)

15 patients/carers with CLTI >=65 with symptoms of anxiety and/or depression

15 staff members caring for patients with CLTI \>=65 with symptoms of anxiety and/or depression

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms of anxiety and/or depression living with critical limb threatening ischaemia (CLTI) being considered for surgical intervention Carers and staff looking after these patients

You may qualify if:

• Patients
• Aged ≥65 years old
• CLTI
• Active symptoms of anxiety or depression (clinician concern)
• Carers
• o In a non-paid caring role for a patient aged ≥65 years with CLTI and active symptoms of anxiety or depression
• Staff o Healthcare professional (vascular surgeons, therapists, clinical nurse specialists, geriatricians, anaesthetists, pharmacists) providing care for people aged ≥65 years with CLTI

You may not qualify if:

• Patients
• Palliative - death anticipated within one month
• Clinical and research team identify as lacking capacity to participate
• Carers
• o Clinical and research team identify as lacking capacity to participate
• Staff o Not providing care for older people with CLTI

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• University Hospitals, Leicester: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE19RT, United Kingdom

Location

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MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Bridget C Strasser, MBBS (Hons) MPHTM BSc

CONTACT

+44 20 7188 7188; b.strasser@nhs.net

Study Design

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

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

GB (1)