Remote Vital Sign Monitoring in Palliative Care Patients Using a Wearable ECG Monitor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOur Lady's Hospice and Care Services
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
Participants will be recruited from the specialist palliative care unit at OLH\&CS.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 1 trial groupGroup A: Palliative Care Patients
Trial outcomes
Primary outcomes
1
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).
Time frame
From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to deathSecondary outcomes
1
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).
Time frame
From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death2
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).
Time frame
From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death3
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).
Time frame
From device initiation until death (up to 14 days), with analysis conducted across predefined time intervals prior to death4
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.
Time frame
From device initiation until death (up to 14 days)Sponsors and contacts
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Source ClinicalTrials.gov