NCT Number: NCT07512505
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Dublin, Ireland
Location status: Recruiting
Andrew Davies, MB BS MSc MD FRCP
PRINCIPAL_INVESTIGATOR
Hailey Goffinet, MSN
CONTACT
Hailey Goffinet, MSN, BSN, RN
SUB_INVESTIGATOR
Michael Connolly, PhD., MSc, BA, RGNT, RNT
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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 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 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 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)
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)
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.
Contact information is provided by the study sponsor or research team.
Hailey Goffinet, MSN
CONTACT
Professor Andrew Davies
CONTACT
Our Lady's Hospice and Care Services
Other
Remote Vital Sign Monitoring in Palliative Care - VITAL-PC
Acronym: VITAL-PC
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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