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Active, Not Recruiting

NCT Number: NCT05621954

Telehealth Interventions for Cardiac Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiac Valve Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Surgical Complication Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool Heart and Chest Hospital

Liverpool, Mersey, L14 3PE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Telehealth Monitoring

Procedure

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

Other names: Docobo, Remote Monitoring, Doc@Home

Primary outcomes

  1. Change from baseline to admission in Healthcare related Quality of Life Change (EQ5D5L)

    Time frame: From baseline to admission for surgery (up to 52 weeks)

    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.

  2. Healthcare resource use during waiting list (composite counts of admission to hospital, A&E attendance and primary care appointment utilisation)

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

    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).

Secondary outcomes

  1. Unplanned admissions pre- and post-surgery

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

    Rates of unplanned admissions to hospital both pre- and post- surgery

  2. Diabetes control

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

    Change from baseline to admission on HbA1c

  3. Smoking cessation

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

    Change from baseline to admission on HbA1c

  4. Post-operative Quality of Life Measures

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

    Healthcare related Quality of Life Change (EQ5D5L change) as an indexed measure from 0 (worst health, equivalent to being dead) to 1 (best health).

  5. Change in post-operative complications

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

    Rates of post-operative complications including mortality, stroke, lower respiratory tract infections, surgical site infections

  6. Length of hospital stay

    Time frame: From admission for surgery to discharge from hospital (up to 52 weeks)

    Total in-hospital stay

  7. Ventilator Time

    Time frame: From admission for surgery to discharge from hospital (up to 52 weeks)

    Total cumulative time with invasive ventilation following index procedure

  8. Length of intensive care stay

    Time frame: From admission for surgery to discharge from hospital (up to 52 weeks)

    Total critical care stay for index admission

  9. Weight loss

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

    Change in body mass index on waiting list

Sponsors and collaborators

Lead sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Other

Collaborators

  • Liverpool Centre for Cardiovascular Science

Registry information

Official study title

Telehealth for Pre- and Post-Operative Monitoring of Cardiac Surgery Patients - A Randomised Controlled Trial

Acronym: TICS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2022
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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