RCT of Mobile Apps & FitBit v. Usual Care

Not Applicable

Active, not recruiting

• Conditions: Gastric Cancer; Hepatic Cancer; Small Bowel Cancer; Rectal Cancer; Pancreatic Cancer; Colon Cancer
• Interventions: Other: Standard of care; Other: Mobile health application and Fitbit + standard of care

• Registration Number: NCT03623464
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

This is a randomized clinical trial to evaluate the use of mobile devices in preventing readmission in patients undergoing major GI cancer operations.

Detailed Description

Patients will be randomized to 1) standard of care or 2) to use our mobile app with standard care. The mobile app will collect information on patients' daily physical activity patterns and health status data for clinicians using smartphone mobile technology applications. The investigators believe that by tracking information on patients, the investigators may be able to intervene sooner and prevent a delay in care.

Study Timeline

• Study First Submitted: 2017-04-24
• Study Start: 2017-05-31
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

1. Subject is 18 years or older
2. Subject speaks English
3. Subject owns a smart phone
4. Subject is scheduled to undergo surgery for a GI cancer (pancreatic, hepatic, gastric, small bowel, colon, or rectal cancers)

Exclusion Criteria

1. Physician deems the subject is unable to complete the study due to documented dementia
2. Subject is undergoing emergent surgery
3. Subject has sepsis from another source
4. Physician deems the subject is unable to complete the study due to documented alcohol and/or drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	Participants will receive standard of care
Mobile app and Fitbit + Standard of care	Mobile health application and Fitbit + standard of care	Mobile health application and Fitbit + standard of care: Participants will utilize mobile app and Fitbit and standard of care. Mobility data will be generated using a mobile health tracker designed for smartphone devices.

Primary Outcome Measures

Name	Time	Method
Readmission rate	30 days	Investigators will track readmission rates after surgery for those on the trial

Secondary Outcome Measures

Name	Time	Method
Healthcare utilization rates	30 days	Investigators will track patients' healthcare resource utilization and the cost of this utilization by assessing how often the patients contact their providers via phone or the app, access the emergency room, and through readmission data.
Patient Satisfaction with Device	30 days	Investigators will assess patients' satisfaction with their care experience and device. This will be done with an internal questionnaire asking if patients were satisfied and if they found it easy to use.
Quality of life: Return to Baseline Function-Activities of Daily Living (ADLs)	30 days	Investigators will monitor patients' return to baseline health after surgery by tracking progress using a questionnaire, modified from the Katz Activities of Daily Living scale. For this scale, a score of 6 is high, indicating that the patient is independent and a score of 0 is low, indicating that the patient very dependent in performing their ADLs.
Quality of life: Return to Baseline Function-Walking	30 days	Investigators will monitor patients' return to baseline health after surgery by tracking progress via step counts, as monitored by a FitBit tracker.

Trial Locations

Locations (1)

Weill Cornell Medicine- New York Presbyterian; 🇺🇸 New York, New York, United States