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

Sponsor
Imperial College Healthcare NHS Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT04792411
Collaborator
Cambridge University Hospitals NHS Foundation Trust (Other), Mid and South Essex NHS Foundation Trust (Other)
50
1
1
15
3.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Prehabilitation
N/A

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 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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.
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prehabilitation group

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

Behavioral: Prehabilitation
Multimodal, tailored prehabilitation programme

Outcome Measures

Primary Outcome Measures

  1. Feasibility of screening and recruitment [18 months]

    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

  2. Feasibility of measurement tools: [18 months]

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

  3. Adherence [at least 6 weeks ( Duration of the programme)]

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

  4. Acceptability of the prehabilitation programme (Patient satisfaction) [18 months]

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

Secondary Outcome Measures

  1. In-Hospital Complication Rate [Immediately after the surgery]

    - Composite of Cardiac, Respiratory, Renal, Haemorrhage, Limb Ischaemia and Cerebral Complications, as defined by National Vascular Registry

  2. 30-day(After surgery) Composite Outcome [30 days]

    Incidence of Mortality Incidence of complications

  3. Length of stay and readmission rates (30 days post-surgery) [30 days]

    Reintervention, or areadmission related to repair or other complications

  4. 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]

    To measure the change of patient physical function

  5. 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]

    Participants quality of life measure throughout the study

  6. Post-Operative Morbidity score (POMS) [Immediately after surgery]

    To measure post operative complications and it's impact on participants

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

    Participants quality of life measure related to aneurysm repair throughout the study

  8. Change in Hospital Anxiety and Depression Score (HADS) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge) [6 weeks, 3 months]

    Participants anxiety and depression score change throughout the study 0-7 (Normal) 8-10 (Mild) 11-15 (Moderate) 16-21 (Severe)

  9. Change in cigarettes usage per day [6 weeks, 3 months]

    Difference in cigarettes usage at different phases of the study

  10. Change in weight (in kg) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge) [6 weeks, 3 months]

    Measure weight change

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Imperial College London London United Kingdom W68RF

Sponsors and Collaborators

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

Investigators

  • Study Chair: Alun Davies, Imperial College NHS Trust
  • Principal Investigator: Tristan Lane, Cambridge University Hospitals NHS Trust
  • Principal Investigator: Ankur Thapar, Mid and South Essex NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT04792411
Other Study ID Numbers:
  • 291828
First Posted:
Mar 11, 2021
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Imperial College Healthcare NHS Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2022