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

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

Multi-centre, Pilot Study Evaluating the Feasibility, Acceptability, and Short-term Outcomes of a Tailored, Virtual, Home-based, Multicomponent Prehabilitation Programme in Patients Undergoing Abdominal Aortic Aneurysms (AAA) Repair.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792411
• Other study ID #: 291828
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Weeks 1 to 5 (conducted remotely via telephone, email or completion of an online survey):

The programme has been developed with experts in the field of sports therapy, physiotherapy and biomechanics, based on robust literature in other fields. The course plan is to start with 3 sessions every week for 6 weeks where participants would complete a tailored home exercise programme or until the expected surgical intervention. In the first week of this programme, the patient will receive three sessions with a total of 150 minutes of exercise according to UK Chief Medical Officers' Physical Activity Guidelines. After each week, we will assess patient tolerance to the exercise regime using Borg scale. The researchers will either increase or decrease exercise intensity according to their feedback. The study will also be assessing patients' preference for how and when they would like to exercise.

End of Programme (conducted remotely via telephone, email or completion of an online survey):

Participants will be contacted by a member of the study team for the reassessment of health-related quality of life, psychological wellbeing and smoking status. Participants will also be required to provide their self-reported weight. On admission for surgery, they will be assessed for frailty using frailty score assessments

Post - Operative Morbidity score(POMS) will be assessed during admission ( Day1, Day 3, Day 5, Day 7, etc) after surgery.

Discharge: (conducted either remotely or face to face):

Participants will complete a reassessment of health-related quality of life, disease-specific quality of life, psychological wellbeing and smoking status. Participants will also complete the 6-MWT.

6 weeks post-surgery (conducted remotely or face-to-face): Participants will complete a reassessment of health-related quality of life, disease-specific quality of life, psychological wellbeing and smoking status. Participants will also complete the 6-MWT.

90-days post-surgery (conducted remotely or face-to-face): Participants will complete reassessment of health-related quality of life, disease-specific quality of life, psychological wellbeing and smoking status. Participants will also complete the 6-MWT. Participants will also complete a frailty assessment score (Rockall)

Treatments Standard national and local practice will be followed for the repair of infra-renal aortic aneurysm. Patients will receive any type of repair as decided by the local Vascular Multi-Disciplinary Team.

Primary Outcome Prehabilitation Programme compliance, attendance and acceptability.

Secondary Outcomes

• In-Hospital Complication Rate - Composite of Cardiac, Respiratory, Renal, Haemorrhage, Limb Ischaemia and Cerebral Complications, as defined by National Vascular Registry

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

• 30-day Composite Outcome: Death and Defined complication (Cardiac, respiratory, haemorrhage, limb ischaemia, renal failure)

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

• 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)

• Post-Operative Morbidity score (POMS)

• Change in aneurysm specific quality of life scores at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)

• Change in Hospital Anxiety and Depression Score (HADS) at 6-weeks post enrolment and 30 and 90-days post-surgery

• Reduction in cigarettes per day at 6-weeks post enrolment and 30 and 90-days post-surgery

• Change in weight (in kg) 6-weeks post enrolment and 30 and 90-days post-surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Behavioral:
• Prehabilitation
Multimodal, tailored prehabilitation programme

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust	Cambridge University Hospitals NHS Foundation Trust, Mid and South Essex NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Adherence	Number of sessions attended The proportion of participants who complete' the 6-week programme	at least 6 weeks ( Duration of the programme)
Primary	Acceptability of the prehabilitation programme (Patient satisfaction)	Patient satisfaction will be measured using questionnaires Reasons for drop-out will be captured.	18 months
Secondary	In-Hospital Complication Rate	- Composite of Cardiac, Respiratory, Renal, Haemorrhage, Limb Ischaemia and Cerebral Complications, as defined by National Vascular Registry	Immediately after the surgery
Secondary	30-day(After surgery) Composite Outcome	Incidence of Mortality Incidence of complications	30 days
Secondary	Length of stay and readmission rates (30 days post-surgery)	Reintervention, or areadmission related to repair or other complications	30 days
Secondary	Change in 6-minute walk test (6-MWT) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)	To measure the change of patient physical function	6 weeks, 3 months
Secondary	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)	Participants quality of life measure throughout the study	6 weeks, 3 months
Secondary	Post-Operative Morbidity score (POMS)	To measure post operative complications and it's impact on participants	Immediately after surgery
Secondary	Change in aneurysm specific quality of life scores at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)	Participants quality of life measure related to aneurysm repair throughout the study	6 weeks, 3 months
Secondary	Change in Hospital Anxiety and Depression Score (HADS) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)	Participants anxiety and depression score change throughout the study 0-7 (Normal) 8-10 (Mild) 11-15 (Moderate) 16-21 (Severe)	6 weeks, 3 months
Secondary	Change in cigarettes usage per day	Difference in cigarettes usage at different phases of the study	6 weeks, 3 months
Secondary	Change in weight (in kg) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)	Measure weight change	6 weeks, 3 months