Telehealth Interventions for Cardiac Surgery

NCT05621954 | Active Not Recruiting

• 1 other identifier: TICS
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

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. 1.Can telehealth improve quality of life prior to surgery
2. 2.Can telehealth prevent serious deterioration requiring hospital or primary care attendance

Conditions

Cardiac Valve Disease; Coronary Artery Disease; Surgical Complication

Keywords

Telehealth; Remote Monitoring; Waiting List; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (9)

• Unplanned admissions pre- and post-surgery

  From baseline to discharge from outpatient cardiac surgery service (up to 52 weeks)

• Diabetes control

  From baseline (randomisation) to admission for surgery (up to 52 weeks)

• Smoking cessation

  From baseline (randomisation) to admission for surgery (up to 52 weeks)

• Post-operative Quality of Life Measures

  From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks)

• Change in post-operative complications

  From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks)

Study Arms (2)

Telehealth monitoring

EXPERIMENTAL

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

Procedure: Telehealth Monitoring

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.

Interventions

Telehealth Monitoring PROCEDURE

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

Also known as: Docobo, Remote Monitoring, Doc@Home

Telehealth monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over 18y referred and accepted for cardiac surgery
• Able to consent to participate

You may not qualify if:

• Urgent or emergent surgery
• Surgery planned within 3 weeks of first cardiac surgery outpatient review

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead
• Liverpool Centre for Cardiovascular Science: collaborator

Study Sites (1)

Liverpool Heart and Chest Hospital

Liverpool, Mersey, L14 3PE, United Kingdom

Location

MeSH Terms

Conditions

Heart Valve Diseases; Coronary Artery Disease

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, single-centre, individual patient, randomized controlled trial

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 18, 2022
• Study Start: April 4, 2023
• Primary Completion: August 8, 2025
• Study Completion: December 1, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)