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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03623464
Other study ID # 1608017482
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 31, 2017
Est. completion date February 2025

Study information

Verified date May 2024
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 107
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
Mobile health application and Fitbit + standard of care
Mobility data will be generated using a mobile health tracker designed for smartphone devices, which allows the phone to automatically and passively (no patient input needed) capture information on the patient's activity; i.e. if the person is walking, remaining stationary, or moving at a rapid speed (eg. in a car). The app will prompt patients once daily to answer a series of questions that will collect patient reported symptoms and health status data. Physicians will be alerted to abnormal values within 24-48 hours and patients will be triggered to call their physicians immediately if the values are outside of normal parameters.
Standard of care
Post-operative standard of care information

Locations

Country Name City State
United States Weill Cornell Medicine- New York Presbyterian New York New York

Sponsors (2)

Lead Sponsor Collaborator
Weill Medical College of Cornell University Damon Runyon Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Readmission rate Investigators will track readmission rates after surgery for those on the trial 30 days
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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