REmote Symptom COllection to improVE postopeRative Care (RECOVER)

March 31, 2025 updated by: Medstar Health Research Institute
There are vulnerabilities in post-discharge care transition for patients after undergoing resection of malignant gastrointestinal tumors. This study aims to investigate the possibility of utilizing Voice-Assisted Remote Symptom Monitoring System (VARSMS) to alleviate some of these challenges.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled trial comparing post-op patients randomized to using the VARSMS vs control.

Study Type

Interventional

Enrollment (Estimated)

281

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • MedStar Health
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Recruiting
        • Creighton University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. At least 18 years old. Ages of subjects >89 will simply be reported as >90.
  2. Scheduled for a GI surgery for management of a tumor in a participating hospital.
  3. Fluent in oral and written English.
  4. Has consistent and continued full access to an operational Wi-Fi for the duration of the study.

Exclusion criteria

  1. Unable to provide informed consent.
  2. Not willing to commit to regular participation in the study to include daily use (40 days) of the study application.
  3. Life expectancy of less than 60 days.
  4. In the opinion of the investigator, participation in this study is contraindicated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Besides the consent process, subjects in this arm will have no other research-specific activities until after 40 days after the surgery for an exit interview.
Experimental: Voice-Assisted Remote Symptom Monitoring System (VARSMS) group
Subjects in this group will be issued the device, to be activated 1 day after discharge. The device will administer a set of questions daily.
Other: Voice-Assisted Remote Symptom Monitoring System (VARSMS)
Utilizing an Alexa Skill activated via an Amazon Echo Dot device, this system will administer two patient-reported outcomes measures to subjects. This will not be used as basis for diagnosis, nor for any clinical intervention.
Other Names:
  • Voice-Assisted Remote Symptom Monitoring System (VARSMS)- customization phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Custom questionnaire based on NCI PRO CTCAE (National Cancer Institute- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events)
Time Frame: 40 days

Daily symptom-based self-reported assessment on dyspnea, fever, melena, pain, wound healing, activities of daily living, sensorium, gastrointestinal motility, dysphagia, pitting edema, mood, and an option to mention symptoms not asked of.

This is monitored by the research team, and any concerning finding, at the discretion of the site's physician, will be relayed to the subject's treating physician.

Treating physician has final decision on whether to address referral by adjustment of management.
40 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SASSI (Subjective Assessment of Speech System Interfaces)
Time Frame: 40 days
After interacting with the speech system for 40 days from the day after discharge, this questionnaire assesses the patient on their experience, having them rate the system based on system response accuracy, likeability, cognitive demand, annoyance, habitability, and speed.
40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007172

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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