Telehealth Interventions for Cardiac Surgery

NCT ID: NCT05621954

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2025-12-31

Brief Summary

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:

1. Can telehealth improve quality of life prior to surgery

2. Can telehealth prevent serious deterioration requiring hospital or primary care attendance

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.

Detailed Description

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.

Conditions

Cardiac Valve Disease; Coronary Artery Disease; Surgical Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Telehealth monitoring

Telehealth remote monitoring provided by a specialised service with a monitoring and patient education app featuring:

• Symptom, blood pressure, weight, heart rate and oxygen saturation monitoring with optional step counters
• Customised algorithms with patient feedback for prehabilitation (e.g. patient self-reporting of symptoms, activities and health-related activities with positive feedback loops and recommendations for self-directed management)
• Centralised weekly review and escalation to expedited surgery if deteriorations noted
• Post-operative monitoring with symptom, blood pressure, weight, heart rate, oxygen saturation and photographic wound review with optional step counters

Group Type: EXPERIMENTAL

Telehealth Monitoring

Intervention Type: PROCEDURE

Connected devices and smartphone apps to measure symptoms and observations at home, with centralisation of results to a staffed hub

Standard of Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telehealth Monitoring

Connected devices and smartphone apps to measure symptoms and observations at home, with centralisation of results to a staffed hub

Intervention Type: PROCEDURE

Other Intervention Names

Docobo; Remote Monitoring; Doc@Home

Eligibility Criteria

Inclusion Criteria

1. Adult patients over 18y referred and accepted for cardiac surgery

2. Able to consent to participate

Exclusion Criteria

1. Urgent or emergent surgery

2. Surgery planned within 3 weeks of first cardiac surgery outpatient review

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liverpool Centre for Cardiovascular Science

UNKNOWN

Sponsor Role: collaborator

Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Liverpool Heart and Chest Hospital

Liverpool, Mersey, United Kingdom

Countries

United Kingdom

Other Identifiers

TICS

Identifier Type: -

Identifier Source: org_study_id