REmote Symptom COllection to improVE postopeRative Care
RECOVER
1 other identifier
interventional
281
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2024
CompletedStudy Start
First participant enrolled
July 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 3, 2025
January 1, 2025
3.2 years
December 19, 2023
March 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Custom questionnaire based on NCI PRO CTCAE (National Cancer Institute- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events)
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 Outcomes (1)
SASSI (Subjective Assessment of Speech System Interfaces)
40 days
Study Arms (2)
Control
NO INTERVENTIONBesides 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.
Voice-Assisted Remote Symptom Monitoring System (VARSMS) group
EXPERIMENTALSubjects in this group will be issued the device, to be activated 1 day after discharge. The device will administer a set of questions daily.
Interventions
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.
Eligibility Criteria
You may qualify if:
- At least 18 years old. Ages of subjects \>89 will simply be reported as \>90.
- Scheduled for a GI surgery for management of a tumor in a participating hospital.
- Fluent in oral and written English.
- Has consistent and continued full access to an operational Wi-Fi for the duration of the study.
You may not qualify if:
- Unable to provide informed consent.
- Not willing to commit to regular participation in the study to include daily use (40 days) of the study application.
- Life expectancy of less than 60 days.
- In the opinion of the investigator, participation in this study is contraindicated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
MedStar Health
Baltimore, Maryland, 21218, United States
Creighton University
Omaha, Nebraska, 68124, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2023
First Posted
January 5, 2024
Study Start
July 23, 2024
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 3, 2025
Record last verified: 2025-01