Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Liverpool Centre for Cardiovascular Science | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to compare telehealth monitoring at home against usual care in patients undergoing planned heart surgery. The main questions it aims to answer are:
Participants awaiting heart surgery will be randomly allocated to either telehealth remote monitoring of symptoms, blood pressure, heart rate, oxygen levels and activity levels or they will be allocated to usual care which is unmonitored on the waiting list for surgery.
Researchers will compare telehealth to usual care to see if it improves quality of life or prevents deteriorations on the waiting list.
Patients on elective cardiac surgery waiting lists can deteriorate, presenting via acute services as urgent inpatients as a result of their decompensation and facing increased surgical risk. With increases in waiting times prevalent through the country, and healthcare resources under pressure from Covid-related backlogs, it is imperative to find ways to monitor and escalate the most vulnerable patients and to provide safe methods of providing healthcare interventions outside conventional hospital settings. Remote monitoring identifies patients at need, and allows tertiary-care led interventions to prevent deterioration in the first instance. Such facilities could also enhance recovery following treatment and reduce the risks of complications and readmissions post-operatively.
The benefits and risks of such programmes is, however, not well understood: additional monitoring may increase the burden of responsibility on patients or monitoring facilities without providing additional safeguards to the patient. The advantages of early detection may not translate into improved outcomes and the onus on the patient to report in may reduce quality of life rather than enhance it.
The researchers therefore seek to identify if telehealth monitoring can improve health related quality of life, reduce unplanned admissions and healthcare resource utilisation and enhance pre-habilitation using protocolised patient engagement facilities to reduce complications and improve risk-stratification metrics such as smoking status, diabetic control and BMI.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth monitoring | Experimental | Telehealth remote monitoring provided by a specialised service with a monitoring and patient education app featuring:
|
|
| Standard of Care | No Intervention | Standard of care will be no remote monitoring for patients whilst on the waiting list or after discharge from hospital. Access to tertiary services for advice, information or to report deteriorations will be through conventional existing modes such as printed or online literature provided at the time of outpatient review, telephone access to administrative staff allowing clinical information to be conveyed to the usual care team, and local primary care and emergency services for acute deteriorations. Existing standard of care remote services (e.g. wound monitoring by digital photograph reviews) will continue. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth Monitoring | Procedure | Connected devices and smartphone apps to measure symptoms and observations at home, with centralisation of results to a staffed hub |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to admission in Healthcare related Quality of Life Change (EQ5D5L) | EQ5D5L will be measured by electronic questionnaire by the patient or a researcher on their behalf and indexed for representation on a scale from 0 (worst health, equivalent to being dead) - 1 (best health). The difference in measures between baseline (randomisation) and admission for surgery (up to 52 weeks) will be measured. | From baseline to admission for surgery (up to 52 weeks) |
| Healthcare resource use during waiting list (composite counts of admission to hospital, A&E attendance and primary care appointment utilisation) | Composite counts of admissions to hospital, Accident & Emergency hospital attendance, and primary care appointments for this health condition or complications of this health condition adjudicated by the research team. The counts will be accrued from baseline (randomisation) to admission for surgery (up to 52 weeks). | From baseline (randomisation) to admission for surgery (up to 52 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Unplanned admissions pre- and post-surgery | Rates of unplanned admissions to hospital both pre- and post- surgery | From baseline to discharge from outpatient cardiac surgery service (up to 52 weeks) |
| Diabetes control |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Heart and Chest Hospital | Liverpool | Mersey | L14 3PE | United Kingdom |
There is no plan to make data widely available. However, should a legitimate request be made by bona fide researchers with data protection legislation equivalent to European Union or United Kingdom General Data Protection Regulations (GDPR), this would not be discounted out of hand. Governance procedures to fully anonymise all identifiable details would be required for any individual participant data, but protocols, analytic source code, data collection forms etc would be shared after publication of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
Not provided
Not provided
| ID | Term |
|---|---|
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
Not provided
Not provided
Pragmatic, single-centre, individual patient, randomized controlled trial
Not provided
Not provided
No masking
Not provided
|
Change from baseline to admission on HbA1c
| From baseline (randomisation) to admission for surgery (up to 52 weeks) |
| Smoking cessation | Change from baseline to admission on HbA1c | From baseline (randomisation) to admission for surgery (up to 52 weeks) |
| Post-operative Quality of Life Measures | Healthcare related Quality of Life Change (EQ5D5L change) as an indexed measure from 0 (worst health, equivalent to being dead) to 1 (best health). | From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks) |
| Change in post-operative complications | Rates of post-operative complications including mortality, stroke, lower respiratory tract infections, surgical site infections | From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks) |
| Length of hospital stay | Total in-hospital stay | From admission for surgery to discharge from hospital (up to 52 weeks) |
| Ventilator Time | Total cumulative time with invasive ventilation following index procedure | From admission for surgery to discharge from hospital (up to 52 weeks) |
| Length of intensive care stay | Total critical care stay for index admission | From admission for surgery to discharge from hospital (up to 52 weeks) |
| Weight loss | Change in body mass index on waiting list | From baseline (randomisation) to admission for surgery (up to 52 weeks) |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |