Adherence and Acceptability of a Remote, Home-based, Pre-surgery Programme for Patients Undergoing Abdominal Aortic Aneurysm Surgery

NCT04792411 | Completed

• 1 other identifier: 291828
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Design A multi-centre pilot study investigating the acceptability and adherence of a prehabilitation on patients requiring abdominal aortic aneurysm repair. Setting 3 NHS Hospital Vascular Surgery Clinics in the UK.

• Imperial College Healthcare NHS Trust
• Cambridge University Hospitals NHS Trust
• Mid and South Essex NHS Trust Patient Population Patients referred to secondary/tertiary vascular clinic for the repair of asymptomatic infrarenal Aneurysm Intervention: Baseline (conducted face-to-face): After providing written informed consent, participants will be provided with information about the prehabilitation programme. The following data will also be collected: baseline demographic characteristics (including age, sex and ethnicity), body mass index (BMI), medical history (including time since diagnosis), current medication, aneurysm diameter, health-related quality of life (EQ-5D-5L and EQ-VAS), smoking status and psychological wellbeing (using the Hospital Anxiety and Depression Scale; HADS) and Frailty assessments( QMortality Index, Electronic Frailty Index, Rockall score). Participants will also complete a 6-minute walking test(6MWT).

Conditions

Aortic Aneurysm, Abdominal

Keywords

AAA, pre-conditioning, frailty

Outcome Measures

Primary Outcomes (4)

• Feasibility of screening and recruitment

  The number of participants referred at each site will be captured The number of participants eligible for screening at each site will be captured The number of participants enrolled at each site will be captured Reasons for non-participation will be captured

  18 months

• Feasibility of measurement tools:

  Time taken to complete the questionnaires at each time-point The ratio of missing data from questionnaires Follow-up response rates

  18 months

• Adherence

  Number of sessions attended The proportion of participants who complete' the 6-week programme

  at least 6 weeks ( Duration of the programme)

• Acceptability of the prehabilitation programme (Patient satisfaction)

  Patient satisfaction will be measured using questionnaires Reasons for drop-out will be captured.

  18 months

Secondary Outcomes (10)

• In-Hospital Complication Rate

  Immediately after the surgery

• 30-day(After surgery) Composite Outcome

  30 days

• Length of stay and readmission rates (30 days post-surgery)

  30 days

• Change in 6-minute walk test (6-MWT) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)

  6 weeks, 3 months

• Change in health-related quality of life scores (using the EuroQol five-dimensional questionnaire [EQ-5D] and visual analogue scale [EQ-VAS]) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)

  6 weeks, 3 months

Study Arms (1)

Prehabilitation group

EXPERIMENTAL

This arm will be subject to at least 6 weeks of a tailored prehabilitation programme

Behavioral: Prehabilitation

Interventions

Prehabilitation BEHAVIORAL

Multimodal, tailored prehabilitation programme

Prehabilitation group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (aged 55 years and over) who have been diagnosed with an AAA and are scheduled to undergo EVAR or open surgery (with a wait time of at least 6-weeks for surgery).
• Patients with an AAA with a diameter of 5.5cm to 7cm
• Able to write, understand and communicate in English
• Willing and able to participate in a virtual prehabilitation programme

You may not qualify if:

• Thoraco-Abdominal Aneurysms
• Connective tissue Vascular Disorder
• Symptomatic aneurysms
• Previous Aortic intervention
• Absolute contraindication to exercise
• Inability or unwillingness to participate in the trial
• Infrarenal AAA diameter exceeding 7.0cm
• Emergency AAA repair
• BMI below 20 kg/m2 or above 45 kg/m2

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• Mid and South Essex NHS Foundation Trust: collaborator

Study Sites (1)

Imperial College London

London, W68RF, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Frailty

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Alun Davies

  Imperial College NHS Trust

  STUDY CHAIR

• Tristan Lane

  Cambridge University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

• Ankur Thapar

  Mid and South Essex NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 11, 2021
• Study Start: September 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)