Remote Electronic Patient Monitoring in Gastrointestinal Cancer

NCT04030624 | Withdrawn FDA Device

• 1 other identifier: 19-329
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this research study is to evaluate a program that involves remote electronic monitoring of vital signs and symptoms of patients with gastrointestinal cancer who were recently hospitalized at Massachusetts General Hospital or presented to the oncology clinic for an unplanned, urgent visit.

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• The Feasibility of Remote Electronic Patient Monitoring Intervention

  The intervention will be deemed feasible if at least 50% (95% confidence interval +/- 13%) of patients agree to participate in the study and sign informed consent, and if participants wear the Remote Electronic Patient Monitoring device ≥ 50% (95% confidence interval +/- 13%) of the time within the two weeks following the baseline time point.

  4 weeks

Secondary Outcomes (11)

• Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period

  4 weeks

• Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period

  4 weeks

• Number of concerning issues identified per patient during study period

  4 weeks

• Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period

  4 weeks

• Number of intervention-triggered emails generated to the primary oncology team during study period

  4 weeks

Study Arms (1)

Remote Electronic Patient Monitoring

EXPERIMENTAL

* The Remote Electronic Patient Monitoring intervention will entail monitoring of vital sign data and patient reported assessments to address and manage any concerning issues identified. * The Remote Patient Monitoring system uses algorithms that can indicate when patient vitals and patient-reported outcomes have changed. * Automatic patient surveys are sent to the patient with results displayed on the clinician user interface (i.e., dashboard) on a computer located in the clinical area. * Qualitative interviews with patient participants and their oncology clinicians using a semi-structured interview guide will be conducted.

Device: Remote Electronic Patient Monitoring

Interventions

Remote Electronic Patient Monitoring DEVICE

The Remote Patient Monitoring intervention is a 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. Throughout the day, patient data from the remote monitoring system are presented on the clinician user interface (e.g., temperature, blood pressure, heart rate, respiration rate). Data are transmitted from sensors to the patient's smart phone.

Remote Electronic Patient Monitoring

Eligibility Criteria

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

You may qualify if:

• Age 18 or older
• Diagnosed with gastrointestinal cancer
• Hospitalized at Massachusetts General Hospital (MGH) or presenting to the ambulatory MGH oncology clinic for an unplanned, urgent visit
• Planning to receive outpatient care at the MGH Cancer Center
• Ability to read and respond to questions in English

You may not qualify if:

• Uncontrolled psychiatric illness or impaired cognition that would interfere with completing study procedures
• Enrolled in hospice
• Planning to be discharged to any location other than their home

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Joseph Greer, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 24, 2019
• Study Start: September 1, 2020
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation