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| Name | Class |
|---|---|
| Imperial College London | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Perioperative multi-component intervention |
|
| Control | No Intervention | Routine inpatient care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perioperative multi-component intervention | Other | Physical Component Self-directed daily non-ambulatory exercise programme, comprising:
Cognitive Component: Delirium prevention strategies including orientation, hydration, bowel/bladder function, infection control, analgesia, polypharmacy and cognitive stimulation Nutritional Component:
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Recruitment rates | Average number of patients per month willing to give informed consent and be randomised into a trial of a perioperative frailty intervention | 1 year |
| Feasibility: Safety | In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality | On discharge: e.g. 2-7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hospital-acquired disability | defined as loss of ≥ 1 ADL at discharge compared to admission; and followed-up at 30 days after discharge | 30 days |
| Incidence of delirium | Assessed daily during hospitalisation by using 4AT until the seventh day post-TAVI and then twice weekly thereafter |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts and the London NHS Trust | London | EC1A 7BE | United Kingdom |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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| Daily (during inpatient admission) until the seventh day post-TAVI and then twice weekly thereafter |
| Changes in health-related quality of life | Measured using EQ-5D-5L at baseline and 30 days post discharge via telephone | 30 days |
| Changes in physical frailty | By comparing SARC-F (strength, assistance with walking, rise form a chair, climb stairs and falls) questionnaire at baseline and 30 days (via telephone) after discharge | 30 days |
| Changes in physical frailty | By comparing dominant handgrip strength at admission and discharge - average of 3 trials of maximal isometric grip measured in kilograms using a Jamar hydraulic hand dynamometer (Anatomy Supply Partners LLC, Georgia, USA). | On discharge: e.g. 2-7 days |
| Changes in physical frailty | By comparing timed chair rises at admission and discharge - time (measures in seconds) to complete five chair rises without using arms. | On discharge: e.g. 2-7 days |
| Change in cognitive function | Assessed using T-MoCA at admission and 30 days post discharge via telephone | 30 days |
| Change in mood | Assessed using HADS at admission and 30 days post discharge via telephone | 30 days |
| Incidence of falls during hospitalisation | On discharge: e.g. 2-7 days |
| Length of hospital stay | Duration of inpatient stay at tertiary centre | On discharge: e.g. 2-7 days |
| Discharge destination | e.g. to patient's own home, long-term care facility or district general hospital | On discharge: e.g. 2-7 days |
| Unplanned readmissions | Measured at 30 days post discharge from tertiary centre using hospital records and patient telephone-interview | 30 days |
| Mortality | Measured at 30 days post discharge using hospital records and NHS Spine database | 30 days |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |