Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04792411
Status:
COMPLETED
Last Update Posted:
2023-10-30
First Post:
2021-03-04
Brief Title:
Adherence and Acceptability of a Remote Home-based Pre-surgery Programme for Patients Undergoing Abdominal Aortic Aneurysm Surgery
Sponsor:
Imperial College Healthcare NHS Trust
Organization:
Imperial College Healthcare NHS Trust
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 secondarytertiary 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 test6MWT
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 secondarytertiary 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 test6MWT
Detailed 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 scorePOMS 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
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 scorePOMS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None