Remote Vital Sign Monitoring in Palliative Care - VITAL-PC
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Mean, standard deviation, median, and range of heart rate variability (HRV) at predefined time intervals prior to death
Study Overview
Brief 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:
- 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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Palliative Care Patients
Patients admitted to the specialist palliative care unit with a primary diagnosis of malignant disease
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Mean, standard deviation, median, and range of heart rate at predefined time intervals prior to death(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(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(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)(From device initiation until death (up to 14 days))
- Number of participants with clinical events (e.g. infection)(From device initiation until death (up to 14 days))
Investigators
Prof Andrew Davies
Professor of Palliative Medicine
Our Lady's Hospice and Care Services