Remote Electronic Patient Monitoring in Oncology Patients

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.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Other: Gaido

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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'.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: Gaido; Patients will participate for up to 21 days. Over the course of the study, 25-100 patients will be enrolled.; Other Names: Remote electronic patient monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Gaido intervention for use by cancer patients	Feasibility will be measured through utilization of the intervention to track statistics such as wear time, completion of patient reported outcomes patients who are meet the criteria and are enrolled in the study. o Analysis of patient wear time for Gaido, using reporting tools as part of the Gaido solution.; Proportion of time that patients wear the Gaido solution; Proportion of participants completing self-reported symptom monitoring through the device; Proportion of participants completing vital sign data entry (blood pressure and oral temperature) through the device	Evaluation last for 3 days after each patient use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Gaido intervention for use by cancer patients	The research team will conduct semi-structured interviews with patients, to obtain feedback on usability and utility of the Gaido solution.	Evaluation last for 3 days after each patient use
Potential impact of Gaido intervention on cancer patient outcomes	To describe health care utilization, potential conditions detected on patients receiving Remote Electronic Patient Monitoring.corresponding interventions on patients receiving Remote Electronic Patient Monitoring.The Electronic Health Record (EHR) will be used to validate the potential Gaido conditions/findings. The following information will be gathered from the EHR: clinical factors (e.g. activities of daily living, tumor staging, diagnosis dates, cancer treatment, prior cancer history, medical comorbidities, and current medications), health care utilization (e.g. inpatient admissions and emergency department visits), and end-of-life care (e.g. death date, hospice enrollment, location of death).	Evaluation last for 3 days after each patient use

Collaborators and Investigators

• Sponsor: Gaido Health
• Collaborators: The Guthrie Clinic
• Investigators: Principal Investigator: Philip Lowry, MD, Guthrie Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): September 9, 2019
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Oncology; Malignancy; Neoplasm; Remote patient monitoring
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: GHBC-0719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No