REmote Symptom COllection to improVE postopeRative Care

NCT ID: NCT06190730

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-23

Study Completion Date

2027-12-31

Brief Summary

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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

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

Conditions

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Gastrointestinal Cancer Gastrointestinal Tumor Gastrointestinal Tumor Surgery Gastrointestinal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The Voice-Assisted Remote Symptom Monitoring System (VARSMS) will be installed on Amazon Echo Dot
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Voice-Assisted Remote Symptom Monitoring System (VARSMS)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Voice-Assisted Remote Symptom Monitoring System (VARSMS)- customization phase

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MedStar Health

Baltimore, Maryland, United States

Site Status RECRUITING

Creighton University

Omaha, Nebraska, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nawar Shara, PhD

Role: CONTACT

301-502-0339

Crisanto Macaraeg, MD

Role: CONTACT

410-261-8218

Other Identifiers

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STUDY00007172

Identifier Type: -

Identifier Source: org_study_id

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