Remote Electronic Patient Monitoring in Oncology Patients

NCT ID: NCT04086251

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2019-12-31

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Gaido Intervention

All patients enrolled in the study will participate in the Gaido Intervention, which entails wearing the Biovotion Everion continuously and take blood pressure and oral temperature spot checks per clinician orders. Patients will also be responsible for filling out PRO surveys and any surveys that trigger as a result of their vital signs falling outside of tailored thresholds.

Group Type: EXPERIMENTAL

Gaido

Intervention Type: OTHER

Patients will participate for up to 21 days. Over the course of the study, 25-100 patients will be enrolled.

Interventions

Gaido

Patients will participate for up to 21 days. Over the course of the study, 25-100 patients will be enrolled.

Intervention Type: OTHER

Other Intervention Names

Remote electronic patient monitoring

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'.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Guthrie Clinic

OTHER

Sponsor Role: collaborator

Gaido Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Lowry, MD

Role: PRINCIPAL_INVESTIGATOR

Guthrie Medical Center

Locations

Guthrie Medical Center

Sayre, Pennsylvania, United States

Countries

United States

Other Identifiers

GHBC-0719

Identifier Type: -

Identifier Source: org_study_id