Remote Electronic Patient Monitoring in Oncology Patients

NCT04086251 | Unknown DMC

• 1 other identifier: GHBC-0719
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Neoplasm; Malignancy; Oncology; Remote patient monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acceptability of Gaido intervention for use by cancer patients

  Evaluation last for 3 days after each patient use

• Potential impact of Gaido intervention on cancer patient outcomes

  Evaluation last for 3 days after each patient use

Study Arms (1)

Gaido Intervention

EXPERIMENTAL

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

Interventions

Gaido OTHER

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

Also known as: Remote electronic patient monitoring

Gaido Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult oncology patients over the age of 18 who are receiving chemotherapy.
• Adult oncology in-patients over the age of 18 who are being being discharged.
• 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.
• Patients who speak, read, and understand English.
• Patients who have access to a smart phone.

You may not qualify if:

• Non-English speaking patients.
• Pregnant women.
• Tattoos on outer side of upper arm (where the heart rate device will be worn).
• Infant or pediatric (age less than 18).
• Dementia, unless accompanied by a full-time caregiver.
• Physically unable to wear the associated wearable devices; for example, amputees (preventing the placement of wearable devices worn on the arm).
• 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.
• Body mass index (BMI) \>35 kg/m2, with conical shaped upper arms with significant adipose tissue (BP measurements might not perform properly).
• Hospice patients who have an 'advanced directive'.

Sponsors & Collaborators

• Gaido Health: lead
• The Guthrie Clinic: collaborator

Study Sites (1)

Guthrie Medical Center

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Philip Lowry, MD

  Guthrie Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: September 11, 2019
• Study Start: September 9, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)