Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2025-12-24 @ 2:40 PM
NCT ID:
NCT04598659
Eligibility Criteria:
Inclusion Criteria:
* The participant is able to provide informed consent.
* The participant is able to comply with the English instructions for using a wearable device (e.g, follow simple instructions, able to answer the telephone, able to answer symptom questions, etc.).
* The participant may have been recently discharged from a hospital care setting (including emergency departments, ward and acute assessment units) to home (including a relative's home) or be currently admitted to a hospital care setting.
* The participant has a recent medical history that suggests there is a risk their health may deteriorate at home. In the first instance we will focus upon patients with at least one of the following conditions:
* Heart Failure (the patient being discharged),
* Arrhythmia (e.g. patient on the waitlist for a pacemaker)
* We will also consider patients with other conditions that present a risk of deterioration at home, for example: COPD, stable angina, liver failure, minor trauma, chronic kidney disease, stroke, hypertension, cancer ( e.g. recent surgery)
Exclusion Criteria:
* Patients that are clinically unstable (eg: respiratory distress, ongoing angina pectoris, sepsis, etc).
* Aphasia or other conditions that prevents the patient from adequately communicating with the researchers.
* Terminal diagnosis with life expectancy \< 3 months.
* Ongoing renal dialysis, or other treatment that prevents the patient from being at home for extended periods.
* Dementia or uncontrolled psychiatric illness.
* Severe dermatitis or another skin disorder that prevents the patient from wearing a patch.
* Patient has a pacemaker or ICD
* Other inability, or unwillingness, to adequately co-operate with the RPM-team.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04598659
Study Brief:
Protocol Section:
NCT04598659