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2017-05-31
2025-08
2025-08
107
NCT03623464
Weill Medical College of Cornell University
Weill Medical College of Cornell University
INTERVENTIONAL
RCT of Mobile Apps & FitBit v. Usual Care
This is a randomized clinical trial to evaluate the use of mobile devices in preventing readmission in patients undergoing major GI cancer operations.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-04-24 | N/A | 2025-03-11 |
2018-08-06 | N/A | 2025-03-14 |
2018-08-09 | N/A | 2025-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Other
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Mobile app 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. | OTHER: Mobile health application and Fitbit + standard of care
|
| OTHER: Standard of care Participants will receive standard of care | OTHER: Mobile health application and Fitbit + standard of care
OTHER: Standard of care
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Readmission rate | Investigators will track readmission rates after surgery for those on the trial | 30 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Healthcare utilization rates | 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. | 30 days |
| Patient Satisfaction with Device | 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. | 30 days |
| Quality of life: Return to Baseline Function-Walking | Investigators will monitor patients' return to baseline health after surgery by tracking progress via step counts, as monitored by a FitBit tracker. | 30 days |
| Quality of life: Return to Baseline Function-Activities of Daily Living (ADLs) | 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. | 30 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
