Clinical trial NCT04086251: Remote Electronic Patient Monitoring in Oncology Patients
Official title: Remote Electronic Patient Monitoring in Oncology Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: Neoplasm
Malignancy
Oncology
Remote patient monitoring
Lead sponsor: Gaido Health
Sponsor class: INDUSTRY
Collaborators: name: The Guthrie Clinic
First posted: 2019-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this research is to study an intervention, which the investigators call "Remote Electronic Patient Monitoring," that entails vital sign data (enabled with smart algorithms for notification) and patient-reported outcomes (PROs), (such as physical and psychological symptoms) intended to address and manage any concerning issues and or diagnoses identified.

Specifically, the plan is a study of oncology patients who will use the Gaido system for up to 21 days or per physician order.

Detailed description: Gaido Health's Remote Patient Monitoring Solution v1.0 is a wireless remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings. Patient information is displayed on a computer located at the medical institution. Every 15 minutes, a measurement is plotted on the User Interface of heart rate / respiration rate (by a Biovotion device). A non-invasive blood pressure (by an Omron device) along with an oral digital thermometer reading are taken per clinician orders and displayed on the Gaido dashboard. Wearable data are transmitted wirelessly from the Biovotion sensor (heart rate and respiratory rate) to the patient's smart phone that relays data to a cloud-based server for storage and analysis. Oral temperature and blood pressure are entered by the patient or care-giver into the patient's smart phone that relays data to a cloud-based server for storage.

The Remote Patient Monitoring system uses algorithms that indicate when patient vitals and patient reported outcomes have changed. Automatic patient surveys are sent to the patient with results displayed both on the computer located in the medical institution and the patient's smart phone. The patient surveys gather patient reported symptoms which are intended to be used in combination with vital signs to support decision-making. The system is intended for use with patients 18 years of age and older who are cared for by healthcare professionals.

Eligibility criteria: Inclusion Criteria:

1. Adult oncology patients over the age of 18 who are receiving chemotherapy.
2. Adult oncology in-patients over the age of 18 who are being being discharged.
3. Patients who have the mental capacity to understand how to use the devices and phone App; or patients who have a 24-hour caregiver who can manage the devices and complete patient surveys.
4. Patients who speak, read, and understand English.
5. Patients who have access to a smart phone.

Exclusion Criteria:

1. Non-English speaking patients.
2. Pregnant women.
3. Tattoos on outer side of upper arm (where the heart rate device will be worn).
4. Infant or pediatric (age less than 18).
5. Dementia, unless accompanied by a full-time caregiver.
6. Physically unable to wear the associated wearable devices; for example, amputees (preventing the placement of wearable devices worn on the arm).
7. Existence of open wounds or skin breakdown in the designated area for wearable device placement or on patients with conditions of irritable skin, per clinician judgment based on patient assessment.
8. Body mass index (BMI) \>35 kg/m2, with conical shaped upper arms with significant adipose tissue (BP measurements might not perform properly).
9. Hospice patients who have an 'advanced directive'.

Primary outcomes:
measure: Feasibility of Gaido intervention for use by cancer patients
timeFrame: Evaluation last for 3 days after each patient use
Secondary outcomes:
measure: Acceptability of Gaido intervention for use by cancer patients
timeFrame: Evaluation last for 3 days after each patient use
measure: Potential impact of Gaido intervention on cancer patient outcomes
timeFrame: Evaluation last for 3 days after each patient use
Other outcomes:
Locations:
city: Sayre
country: United States
facility: Guthrie Medical Center
state: Pennsylvania
Study officials:
affiliation: Guthrie Medical Center
name: Philip Lowry, MD
role: PRINCIPAL_INVESTIGATOR
References: