CancerVITAL-PCNCT07512505
Remote Vital Sign Monitoring in Palliative Care Patients Using a Wearable ECG Monitor
An observational study of Cancer and Malignancies Multiple, run by Our Lady's Hospice and Care Services at 1 site in Ireland.
Trial summary
The goal of this study is the assess the use of remote monitoring of vital signs using commercially available medical devices in patients with advanced cancer admitted to a hospice inpatient unit for end-of-life care. The objectives of the study are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Malignancies Multiple, Terminal Care
- How many people
- 120 participants
- Where
- 1 siteIreland
- Study dates
- 6 Nov 2025to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Participants will be recruited from the specialist palliative care unit at OLH\&CS.
Who may be able to join
- Age ≥ 18 years old
- Primary diagnosis of malignant disease
- Admitted for end-of-life care (or focus of care changed to end-of-life care)
- Estimated prognosis < 14 days
Who cannot join
- Primary diagnosis of non-malignant disease
- Inability to provide informed consent
- Contraindications to use of biosensor adhesive patch (e.g. chest wall skin problem, allergy to adhesive)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Our Lady's Hospice and Care Services
Dublin
Hailey Goffinet, MSN, +353 014982537, hgoffinet@olh.ie
Hailey Goffinet, MSN, BSN, RN
About this study
Official title: Remote Vital Sign Monitoring in Palliative Care - VITAL-PC
The goal of this study is the assess the use of remote monitoring of vital signs using commercially available medical devices in patients with advanced cancer admitted to a hospice inpatient unit for end-of-life care.
The objectives of the study are:
- could remote monitoring of vital signs improve patient care through the earlier identification of infections and other (potentially reversible) problems;
- could remote monitoring of vital signs improve the accuracy of our estimates about how long a person has to live; and c) determine the relationship between complaints of pain / other symptoms and vital signs.
Read the detailed description
This study will take place in the palliative care unit at Our Lady's Hospice \& Care Services and will consist of applying a small, flexible, patch-like device to the participant's chest with an adhesive patch.
If the participant is happy to take part in the study, they will be visited by a member of the research team. This meeting provides the opportunity to discuss the study, answer any questions and complete a consent form.
The researcher will also collect some information about the participant's condition, and medication from their medical notes and drug chart. The participant will need to wear the device for the duration of their time in the hospice. The research team will remotely check that the device is working properly, and will change the device when the battery needs re-charging (every 14 days). The research team will review the participant after 24 hr (to ensure no problems), and then a couple of times a week during the study. The nursing team will check that the patch is sticking properly every day.
The medical / nursing team will not have access to the information from the device, and so will not make any clinical decisions on the basis of this information.
The device will continue to be worn until the patient dies, the patient withdraws, the patient is discharged, or the patient improves (and is no longer receiving end-of-life care). At the end of the participant's stay on the hospice the device will be removed and cleaned / sterilized according to the manufacturer's instructions (the adhesive patches that secure the device to the chest wall are disposable / not reusable).
The study will recruit 120 patients - this number is pragmatic, and based upon annual admission data for OLH\&CS (and the likelihood of end-of-life patients to engage in research).
Currently, the plan is to use descriptive statistics, and standard statistical methods to analyse the study data. However, we are engaging with colleagues at UCD about using machine learning to undertake further analyses. A formal statistical analysis plan will be developed prior to the primary analysis.
- Conditions
- Cancer, Malignancies Multiple, Terminal Care, Hospice
- Keywords
- Remote Monitoring, Vital Sign Monitoring, End-of-life care, Terminal Care, Remote monitoring of vital signs in palliative care, Palliative care, Hospice, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Palliative Care Patients | Patients admitted to the specialist palliative care unit with a primary diagnosis of malignant disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean, standard deviation, median, and range of heart rate variability (HRV) at predefined time intervals prior to death
Summary statistics (mean, standard deviation, median, and range) of heart rate variability defined as the Root Mean Square of Successive Differences (RMSSD), measured using a wearable ECG patch at predefined time intervals prior to death (0-24 hours, 24-48 hours, 48-72 hours, 72 hours-7 days, and 7-14 days).
Measured: From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death
Secondary outcomes (5)
Mean, standard deviation, median, and range of heart rate at predefined time intervals prior to death
Summary statistics (mean, standard deviation, median, and range) of heart rate measured using a wearable ECG patch at predefined time intervals prior to death (0-24 hours, 24-48 hours, 48-72 hours, 72 hours-7 days, and 7-14 days).
Measured: From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death
Mean, standard deviation, median, and range of respiratory rate at predefined time intervals prior to death
Summary statistics (mean, standard deviation, median, and range) of respiratory rate measured using a wearable ECG patch at predefined time intervals prior to death (0-24 hours, 24-48 hours, 48-72 hours, 72 hours-7 days, and 7-14 days).
Measured: From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death
Mean, standard deviation, median, and range of skin temperature at predefined time intervals prior to death
Summary statistics (mean, standard deviation, median, and range) of skin temperature measured using a wearable ECG patch at predefined time intervals prior to death (0-24 hours, 24-48 hours, 48-72 hours, 72 hours-7 days, and 7-14 days).
Measured: From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death
Number of participants with clinical events (e.g. increased PRN medication use)
Association between changes in physiological parameters (heart rate, respiratory rate, HRV, temperature, activity) measured using a wearable ECG patch and occurrence of increased PRN medication use collected through retrospective chart review.
Measured: From device initiation until death (up to 14 days)
Number of participants with clinical events (e.g. infection)
Association between changes in physiological parameters (heart rate, respiratory rate, HRV, temperature, activity) measured using a wearable ECG patch and occurrence of infection collected through retrospective chart review.
Measured: From device initiation until death (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start6 Nov 2025
- Primary completion6 Nov 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Our Lady's Hospice and Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Andrew Davies, Our Lady's Hospice and Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512505
- Sponsor's protocol ID
- RS25-044
- Acronym
- VITAL-PC
- Status last verified
- Dec 2025
- First submitted
- 23 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Power J, Gouldthorpe C, Davies A. Vital Signs in Palliative Care: A Scoping Review. Cancers (Basel). 2023 Sep 20;15(18):4641. doi: 10.3390/cancers15184641.
PubMed 37760611Seymour JE. Revisiting medicalisation and 'natural' death. Soc Sci Med. 1999 Sep;49(5):691-704. doi: 10.1016/s0277-9536(99)00170-7.
PubMed 10452423Ellershaw J, Wilkinson S. Care of the dying. a pathway to excellence. Oxford University Press: Oxford, UK; 2003.
Veerbeek L, van Zuylen L, Swart SJ, van der Maas PJ, van der Heide A. The last 3 days of life in three different care settings in The Netherlands. Support Care Cancer. 2007 Oct;15(10):1117-23. doi: 10.1007/s00520-006-0211-x. Epub 2007 Mar 15.
PubMed 17357794Olsson T, Terent A, Lind L. Rapid Emergency Medicine score: a new prognostic tool for in-hospital mortality in nonsurgical emergency department patients. J Intern Med. 2004 May;255(5):579-87. doi: 10.1111/j.1365-2796.2004.01321.x.
PubMed 15078500
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Vital Sign Monitoring in Palliative Care - VITAL-PC
- ClinicalTrials.gov ID
- NCT07512505
- Acronym / sponsor ID
- VITAL-PC / RS25-044
- Conditions
- Cancer, Malignancies Multiple, Terminal Care, Hospice
- Keywords
- Remote Monitoring, Vital Sign Monitoring, End-of-life care, Terminal Care, Remote monitoring of vital signs in palliative care, Palliative care, Hospice, Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Our Lady's Hospice and Care ServicesUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 6 Nov 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 6 Apr 2026 (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 study is the assess the use of remote monitoring of vital signs using commercially available medical devices in patients with advanced cancer admitted to a hospice inpatient unit for end-of-life care.
The objectives of the study are:
- could remote monitoring of vital signs improve patient care through the earlier identification of infections and other (potentially reversible) problems;
- could remote monitoring of vital signs improve the accuracy of our estimates about how long a person has to live; and c) determine the relationship between complaints of pain / other symptoms and vital signs.
Detailed description
This study will take place in the palliative care unit at Our Lady's Hospice \& Care Services and will consist of applying a small, flexible, patch-like device to the participant's chest with an adhesive patch.
If the participant is happy to take part in the study, they will be visited by a member of the research team. This meeting provides the opportunity to discuss the study, answer any questions and complete a consent form.
The researcher will also collect some information about the participant's condition, and medication from their medical notes and drug chart. The participant will need to wear the device for the duration of their time in the hospice. The research team will remotely check that the device is working properly, and will change the device when the battery needs re-charging (every 14 days). The research team will review the participant after 24 hr (to ensure no problems), and then a couple of times a week during the study. The nursing team will check that the patch is sticking properly every day.
The medical / nursing team will not have access to the information from the device, and so will not make any clinical decisions on the basis of this information.
The device will continue to be worn until the patient dies, the patient withdraws, the patient is discharged, or the patient improves (and is no longer receiving end-of-life care). At the end of the participant's stay on the hospice the device will be removed and cleaned / sterilized according to the manufacturer's instructions (the adhesive patches that secure the device to the chest wall are disposable / not reusable).
The study will recruit 120 patients - this number is pragmatic, and based upon annual admission data for OLH\&CS (and the likelihood of end-of-life patients to engage in research).
Currently, the plan is to use descriptive statistics, and standard statistical methods to analyse the study data. However, we are engaging with colleagues at UCD about using machine learning to undertake further analyses. A formal statistical analysis plan will be developed prior to the primary analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palliative Care Patients | – | –Patients admitted to the specialist palliative care unit with a primary diagnosis of malignant disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the specialist palliative care unit at OLH\&CS.
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Primary diagnosis of malignant disease
- Admitted for end-of-life care (or focus of care changed to end-of-life care)
- Estimated prognosis < 14 days
Key exclusion criteria (3 listed)
- Primary diagnosis of non-malignant disease
- Inability to provide informed consent
- Contraindications to use of biosensor adhesive patch (e.g. chest wall skin problem, allergy to adhesive)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean, standard deviation, median, and range of heart rate variability (HRV) at predefined time intervals prior to death
Time frame: From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death
Summary statistics (mean, standard deviation, median, and range) of heart rate variability defined as the Root Mean Square of Successive Differences (RMSSD), measured using a wearable ECG patch at predefined time intervals prior to death (0-24 hours, 24-48 hours, 48-72 hours, 72 hours-7 days, and 7-14 days).
5 secondary outcomes
Mean, standard deviation, median, and range of heart rate at predefined time intervals prior to death
Time frame: From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death
Mean, standard deviation, median, and range of respiratory rate at predefined time intervals prior to death
Time frame: From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death
Mean, standard deviation, median, and range of skin temperature at predefined time intervals prior to death
Time frame: From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death
Number of participants with clinical events (e.g. increased PRN medication use)
Time frame: From device initiation until death (up to 14 days)
Number of participants with clinical events (e.g. infection)
Time frame: From device initiation until death (up to 14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 37760611Power J, Gouldthorpe C, Davies A. Vital Signs in Palliative Care: A Scoping Review. Cancers (Basel). 2023 Sep 20;15(18):4641. doi: 10.3390/cancers15184641.
- Background: PubMed 10452423Seymour JE. Revisiting medicalisation and 'natural' death. Soc Sci Med. 1999 Sep;49(5):691-704. doi: 10.1016/s0277-9536(99)00170-7.
- BackgroundEllershaw J, Wilkinson S. Care of the dying. a pathway to excellence. Oxford University Press: Oxford, UK; 2003.
- Background: PubMed 17357794Veerbeek L, van Zuylen L, Swart SJ, van der Maas PJ, van der Heide A. The last 3 days of life in three different care settings in The Netherlands. Support Care Cancer. 2007 Oct;15(10):1117-23. doi: 10.1007/s00520-006-0211-x. Epub 2007 Mar 15.
- Background: PubMed 15078500Olsson T, Terent A, Lind L. Rapid Emergency Medicine score: a new prognostic tool for in-hospital mortality in nonsurgical emergency department patients. J Intern Med. 2004 May;255(5):579-87. doi: 10.1111/j.1365-2796.2004.01321.x.
- Information on validated wearable device used in this study.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Malignancies Multiple, run by Our Lady's Hospice and Care Services at 1 site in Ireland.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Apr 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 Ireland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hailey Goffinet, MSN (+353 014982537, hgoffinet@olh.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean, standard deviation, median, and range of heart rate variability (HRV) at predefined time intervals prior to death (time frame: From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07512505, which also lists 5 linked publications.
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 6 Apr 2026.