REmote Symptom COllection to improVE postopeRative Care (RECOVER)

MedStar Health

Status: Enrolling

Conditions: Gastrointestinal Tumor Surgery; Gastrointestinal Cancer; Gastrointestinal Tumor; Gastrointestinal Surgery

Treatments: Other: Voice-Assisted Remote Symptom Monitoring System (VARSMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06190730

STUDY00007172

Details and patient eligibility

About

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.

Full description

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

Enrollment: 281 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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281 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Voice-Assisted Remote Symptom Monitoring System (VARSMS) group

Experimental group

Description:

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.

Treatment:

Other: Voice-Assisted Remote Symptom Monitoring System (VARSMS)