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Using Patient Centered Data and Behavioral Economics to Improve Mobility and Reduce Readmissions After Major Abdominal Surgery (FITBIT)

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
social incentive-based gamification
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or older
  • diagnosis of cancer undergoing definitive surgical treatment

Exclusion Criteria:

  • Inability to provide consent
  • does not have daily access to a smartphone compatible with the wearable device and not willing to use a device that the investigators can provide them
  • any other medical conditions that would prohibit participation in a physical activity program

Sites / Locations

  • Abramson Cancer Center
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Participants in the intervention arm will have a postoperative daily step goal that increases from baseline by 500 steps each day.

Participants in the control group will have data collected passively via Fitbit.

Outcomes

Primary Outcome Measures

Change in mean daily step count from the baseline step count during two days after the surgery to the hospital discharge
Change in mean daily step count

Secondary Outcome Measures

Change in mean daily step count from the postoperative baseline to 3 months after discharge from the hospital
Change in mean daily step count

Full Information

First Posted
January 9, 2020
Last Updated
November 8, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04314778
Brief Title
Using Patient Centered Data and Behavioral Economics to Improve Mobility and Reduce Readmissions After Major Abdominal Surgery
Acronym
FITBIT
Official Title
Using Patient Centered Data and Behavioral Economics to Improve Mobility and Reduce Readmissions After Major Abdominal Surgery for Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a two-arm randomized, controlled trial during the postoperative period after major abdominal surgery for cancer, including for example radical cystectomy, nephrectomy, colectomy, comparing a control group that uses a wearable device to track physical activity to an intervention group that uses the same wearable devices and receives a supportive social incentive-based gamification intervention to adhere to a step goal program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants in the intervention arm will have a postoperative daily step goal that increases from baseline by 500 steps each day.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in the control group will have data collected passively via Fitbit.
Intervention Type
Behavioral
Intervention Name(s)
social incentive-based gamification
Intervention Description
At the beginning of each week, starting from postoperative day 3, the participant receives 70 points (10 points for each day that week). If the participant does not meet their daily step goal, they lose 10 points from their balance. This leverages loss aversion, which has been demonstrated to motivate behavior change more effectively with losses than gains. At the end of each week if the participant has at least 40 points, they will move up a level (levels from lowest to highest: blue, bronze, silver, gold, platinum). If not, the participant will drop a level. All participants begin at the silver level. Each week, participants get a fresh set of 70 points. Participants will receive daily feedback for the step counts, and weekly feedback for their levels. Participants in the intervention arm will be asked to identify a family member or friend to be their support sponsor. A weekly report will be sent to this person with the participant's performance (points and level).
Primary Outcome Measure Information:
Title
Change in mean daily step count from the baseline step count during two days after the surgery to the hospital discharge
Description
Change in mean daily step count
Time Frame
From baseline step count after a two-day run-in period after the surgery to the time of hospital discharge postoperatively.
Secondary Outcome Measure Information:
Title
Change in mean daily step count from the postoperative baseline to 3 months after discharge from the hospital
Description
Change in mean daily step count
Time Frame
From the postoperative baseline step count during 2 day run-in to 3 months after discharge from the hospital.
Other Pre-specified Outcome Measures:
Title
Rate of placement to skilled nursing facility after hospital discharge
Description
Rate of placement to skilled nursing facility postoperatively
Time Frame
13 weeks after hospital discharge
Title
Rate of 90 day hospital readmission after hospital discharge
Description
Rate of 90 day hospital readmission
Time Frame
90 days after hospital discharge
Title
Rate of postoperative complications
Description
Rate of complications after the surgery
Time Frame
Immediately after the surgery to 3 months postoperatively
Title
Rate of postoperative delirium
Description
Rate of delirium after the surgery
Time Frame
Immediately after the surgery to 3 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older diagnosis of cancer undergoing definitive surgical treatment Exclusion Criteria: Inability to provide consent does not have daily access to a smartphone compatible with the wearable device and not willing to use a device that the investigators can provide them any other medical conditions that would prohibit participation in a physical activity program
Facility Information:
Facility Name
Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Using Patient Centered Data and Behavioral Economics to Improve Mobility and Reduce Readmissions After Major Abdominal Surgery

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