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Clinical Trials/NCT06190730
NCT06190730
Recruiting
Not Applicable

REmote Symptom COllection to improVE postopeRative Care

Medstar Health Research Institute2 sites in 1 country281 target enrollmentJuly 23, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Medstar Health Research Institute
Enrollment
281
Locations
2
Primary Endpoint
Custom questionnaire based on NCI PRO CTCAE (National Cancer Institute- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
July 23, 2024
End Date
December 31, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medstar Health Research Institute
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • SASSI (Subjective Assessment of Speech System Interfaces)(40 days)

Study Sites (2)

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