RCT of Mobile Apps & FitBit v. Usual Care
Primary Purpose
Pancreatic Cancer, Gastric Cancer, Hepatic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile health application and Fitbit + standard of care
Standard of care
Sponsored by
About this trial
This is an interventional prevention trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Subject is 18 years or older
- Subject speaks English
- Subject owns a smart phone
- Subject is scheduled to undergo surgery for a GI cancer (pancreatic, hepatic, gastric, small bowel, colon, or rectal cancers)
Exclusion Criteria:
- Physician deems the subject is unable to complete the study due to documented dementia
- Subject is undergoing emergent surgery
- Subject has sepsis from another source
- Physician deems the subject is unable to complete the study due to documented alcohol and/or drug abuse
Sites / Locations
- Weill Cornell Medicine- New York PresbyterianRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Mobile app and Fitbit + Standard of care
Standard of care
Arm Description
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.
Participants will receive standard of care
Outcomes
Primary Outcome Measures
Readmission rate
Investigators will track readmission rates after surgery for those on the trial
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT03623464
First Posted
April 24, 2017
Last Updated
December 5, 2022
Sponsor
Weill Medical College of Cornell University
Collaborators
Damon Runyon Cancer Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03623464
Brief Title
RCT of Mobile Apps & FitBit v. Usual Care
Official Title
Randomized Clinical Trial of FitBit and Mobile Apps Versus Usual Care to Improve Post-Operative Outcomes After GI Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Damon Runyon Cancer Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Gastric Cancer, Hepatic Cancer, Colon Cancer, Rectal Cancer, Small Bowel Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
316 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mobile app and Fitbit + Standard of care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard of care
Arm Type
Other
Arm Description
Participants will receive standard of care
Intervention Type
Other
Intervention Name(s)
Mobile health application and Fitbit + standard of care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Post-operative standard of care information
Primary Outcome Measure Information:
Title
Readmission rate
Description
Investigators will track readmission rates after surgery for those on the trial
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Healthcare utilization rates
Description
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.
Time Frame
30 days
Title
Patient Satisfaction with Device
Description
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.
Time Frame
30 days
Title
Quality of life: Return to Baseline Function-Walking
Description
Investigators will monitor patients' return to baseline health after surgery by tracking progress via step counts, as monitored by a FitBit tracker.
Time Frame
30 days
Title
Quality of life: Return to Baseline Function-Activities of Daily Living (ADLs)
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is 18 years or older
Subject speaks English
Subject owns a smart phone
Subject is scheduled to undergo surgery for a GI cancer (pancreatic, hepatic, gastric, small bowel, colon, or rectal cancers)
Exclusion Criteria:
Physician deems the subject is unable to complete the study due to documented dementia
Subject is undergoing emergent surgery
Subject has sepsis from another source
Physician deems the subject is unable to complete the study due to documented alcohol and/or drug abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jujhar Singh
Phone
646-962-2789
Email
jus4018@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julianna Brouwer, MPH
Phone
6469622394
Email
jub2024@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Yeo, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine- New York Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julianna Program Manager, MPH
Phone
212-746-5578
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RCT of Mobile Apps & FitBit v. Usual Care
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