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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.
Randomized controlled trial comparing post-op patients randomized to using the VARSMS vs control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voice-Assisted Remote Symptom Monitoring System (VARSMS) | 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. |
| 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| SASSI (Subjective Assessment of Speech System Interfaces) | 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 |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nawar Shara, PhD | Contact | 301-502-0339 | nawar.shara@medstar.net | |
| Crisanto Macaraeg, MD | Contact | 410-261-8218 | crisanto.l.macaraeg@medstar.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Health | Recruiting | Baltimore | Maryland | 21218 | United States | |
| Creighton University |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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The Voice-Assisted Remote Symptom Monitoring System (VARSMS) will be installed on Amazon Echo Dot
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| Recruiting |
| Omaha |
| Nebraska |
| 68124 |
| United States |