Remote Vital Sign Monitoring in Palliative Care Patients Using a Wearable ECG Monitor (VITAL-PC)

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:

1. could remote monitoring of vital signs improve patient care through the earlier identification of infections and other (potentially reversible) problems;
2. 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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Malignancies Multiple; Hospice; Terminal Care

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Hailey Goffinet, MSN; Phone Number: +353 014982537; Email: hgoffinet@olh.ie
• Study Contact Backup: Name: Professor Andrew Davies; Phone Number: +353 014986235; Email: andavies@tcd.ie

Study Locations

• Ireland
  • Dublin, Ireland
    • Recruiting
    • Our Lady's Hospice and Care Services
    • Contact: Hailey Goffinet, MSN; Phone Number: +353 014982537; Email: hgoffinet@olh.ie
    • Sub-Investigator: Hailey Goffinet, MSN, BSN, RN
    • Principal Investigator: Andrew Davies, MB BS MSc MD FRCP
    • Sub-Investigator: Michael Connolly, PhD., MSc, BA, RGNT, RNT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the specialist palliative care unit at OLH&CS.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Palliative Care Patients; Patients admitted to the specialist palliative care unit with a primary diagnosis of malignant disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	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.	From device initiation until death (up to 14 days)

Collaborators and Investigators

• Sponsor: Our Lady's Hospice and Care Services

Publications and helpful links

General Publications

• Power J, Gouldthorpe C, Davies A. Vital signs in palliative care: a scoping review. Cancers 2023; 15: 4651.
• Seymour JE. Revisiting medicalisation and 'natural' death. Soc Sci Med 1999; 49: 691-704.
• Ellershaw 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; 15: 1117-23.
• Olsson 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; 255: 579-87.

Helpful Links

• Information on validated wearable device used in this study.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2025
• Primary Completion (Estimated): November 6, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Palliative care; Remote Monitoring; Hospice; End-of-life care; Terminal Care; Vital Sign Monitoring; Remote monitoring of vital signs in palliative care
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: RS25-044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No