A Pilot Study Assessing the Feasibility and Effectiveness of a Perioperative Multi-component Intervention in Patients With Acute Decompensated Aortic Stenosis Undergoing Urgent Transcatheter Aortic Valve Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Barts & The London NHS Trust
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Feasibility: Safety
Study Overview
Brief Summary
This is a pilot randomised control study assessing the feasibility and effectiveness of a perioperative multi-component intervention aimed at reducing adverse hospital events and improving functional outcomes in patients with acute decompensated aortic stenosis undergoing urgent transcatheter aortic valve implantation compared to standard care.
The intervention will consist of physical rehabilitation, delirium prevention, nutritional supplementation and anaemia correction (where indicated). The primary objective is to determine the feasibility and safety of delivering this intervention Secondary objectives include investigating the impact on adverse hospital events such as hospital-acquired disability and post-TAVI delirium, and on health-related quality of life and functional recovery following TAVI.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 70 years
- •Ability to provide written informed consent
- •Ability to speak English
- •Exclusion criteria:
- •Clinical instability defined as requiring use of inotropes/mechanical-circulatory support during admission or post-cardiac arrest
- •Active delirium (4AT score ≥ 4) at time of recruitment
- •Parkinson's disease (Hoehn & Yahr stage 3-5)
- •Recent stroke (within 7 days preceding recruitment)
- •Terminal condition (e.g. metastatic cancer) with life expectancy < 12 months
- •Clinical unsuitable for recruitment to trial according to the discretion of the research team
Exclusion Criteria
- Not provided
Arms & Interventions
Control
Routine inpatient care
Intervention
Perioperative multi-component intervention
Intervention: Perioperative multi-component intervention (Other)
Outcomes
Primary Outcomes
Feasibility: Safety
Time Frame: On discharge: e.g. 2-7 days
In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality
Feasibility: Recruitment rates
Time Frame: 1 year
Average number of patients per month willing to give informed consent and be randomised into a trial of a perioperative frailty intervention
Secondary Outcomes
- Change in cognitive function(30 days)
- Incidence of hospital-acquired disability(30 days)
- Incidence of delirium(Daily (during inpatient admission) until the seventh day post-TAVI and then twice weekly thereafter)
- Changes in health-related quality of life(30 days)
- Change in mood(30 days)
- Incidence of falls during hospitalisation(On discharge: e.g. 2-7 days)
- Length of hospital stay(On discharge: e.g. 2-7 days)
- Discharge destination(On discharge: e.g. 2-7 days)
- Unplanned readmissions(30 days)
- Mortality(30 days)
- Changes in physical frailty(On discharge: e.g. 2-7 days)