Cardiac Valve DiseaseTICSNCT05621954
Telehealth Interventions for Cardiac Surgery
A study testing Telehealth Monitoring in people with Cardiac Valve Disease and Coronary Artery Disease, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Valve Disease, Coronary Artery Disease, Surgical Complication
- What is being tested?
- Telehealth Monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over 18y referred and accepted for cardiac surgery
- Able to consent to participate
Who cannot join
- Urgent or emergent surgery
- Surgery planned within 3 weeks of first cardiac surgery outpatient review
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Heart and Chest Hospital
Liverpool, Mersey, L14 3PE
About this study
Official title: Telehealth for Pre- and Post-Operative Monitoring of Cardiac Surgery Patients - A Randomised Controlled Trial
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:
- Can telehealth improve quality of life prior to surgery
- Can telehealth prevent serious deterioration requiring hospital or primary care attendance
Read more
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.
Read the 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.
- Being tested
- Telehealth Monitoring
- Keywords
- Telehealth, Remote Monitoring, Waiting List, Quality of Life
- Medical subject headings
- Heart Valve Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth MonitoringProcedure or surgery
Also called Docobo, Remote Monitoring, Doc@Home
Connected devices and smartphone apps to measure symptoms and observations at home, with centralisation of results to a staffed hub
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Measured: From baseline (randomisation) to admission for surgery (up to 52 weeks)
Secondary outcomes (9)
Unplanned admissions pre- and post-surgery
Rates of unplanned admissions to hospital both pre- and post- surgery
Measured: From baseline to discharge from outpatient cardiac surgery service (up to 52 weeks)
Diabetes control
Change from baseline to admission on HbA1c
Measured: From baseline (randomisation) to admission for surgery (up to 52 weeks)
Smoking cessation
Change from baseline to admission on HbA1c
Measured: 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).
Measured: 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
Measured: From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks)
Length of hospital stay
Total in-hospital stay
Measured: From admission for surgery to discharge from hospital (up to 52 weeks)
Ventilator Time
Total cumulative time with invasive ventilation following index procedure
Measured: From admission for surgery to discharge from hospital (up to 52 weeks)
Length of intensive care stay
Total critical care stay for index admission
Measured: From admission for surgery to discharge from hospital (up to 52 weeks)
Weight loss
Change in body mass index on waiting list
Measured: From baseline (randomisation) to admission for surgery (up to 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start23 Mar 2023
- Primary completion31 Dec 2024
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, single-centre, individual patient, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool Centre for Cardiovascular Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621954
- Sponsor's protocol ID
- TICS
- Acronym
- TICS
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth for Pre- and Post-Operative Monitoring of Cardiac Surgery Patients - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05621954
- Acronym / sponsor ID
- TICS / TICS
- Keywords
- Telehealth, Remote Monitoring, Waiting List, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Liverpool Centre for Cardiovascular Science
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can telehealth improve quality of life prior to surgery
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic, single-centre, individual patient, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Telehealth monitoring | Experimental | Procedure: Telehealth MonitoringTelehealth 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients over 18y referred and accepted for cardiac surgery
- Able to consent to participate
Key exclusion criteria (2 listed)
- Urgent or emergent surgery
- Surgery planned within 3 weeks of first cardiac surgery outpatient review
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth MonitoringAlso: Docobo, Remote Monitoring, Doc@HomeConnected devices and smartphone apps to measure symptoms and observations at home, with centralisation of results to a staffed hub | Procedure or surgery | Telehealth monitoring |
Primary outcome
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.
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).
9 secondary outcomes
Unplanned admissions pre- and post-surgery
Time frame: From baseline to discharge from outpatient cardiac surgery service (up to 52 weeks)
Diabetes control
Time frame: From baseline (randomisation) to admission for surgery (up to 52 weeks)
Smoking cessation
Time frame: From baseline (randomisation) to admission for surgery (up to 52 weeks)
Post-operative Quality of Life Measures
Time frame: From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks)
Change in post-operative complications
Time frame: From discharge from hospital admission to discharge from outpatient cardiac surgery service (up to 52 weeks)
Length of hospital stay
Time frame: From admission for surgery to discharge from hospital (up to 52 weeks)
Ventilator Time
Time frame: From admission for surgery to discharge from hospital (up to 52 weeks)
Length of intensive care stay
Time frame: From admission for surgery to discharge from hospital (up to 52 weeks)
Weight loss
Time frame: From baseline (randomisation) to admission for surgery (up to 52 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Monitoring in people with Cardiac Valve Disease and Coronary Artery Disease, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.