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

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT04314778

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Behavioral: social incentive-based gamification	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 15, 2019

Anticipated Primary Completion Date :

Aug 15, 2022

Anticipated Study Completion Date :

Aug 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Participants in the intervention arm will have a postoperative daily step goal that increases from baseline by 500 steps each day.	Behavioral: social incentive-based gamification 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).
No Intervention: Control Participants in the control group will have data collected passively via Fitbit.

Arm

Intervention/Treatment

Experimental: Intervention

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

Behavioral: social incentive-based gamification

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).

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

Change in mean daily step count from the baseline step count during two days after the surgery to the hospital discharge [From baseline step count after a two-day run-in period after the surgery to the time of hospital discharge postoperatively.]
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 [From the postoperative baseline step count during 2 day run-in to 3 months after discharge from the hospital.]
Change in mean daily step count

Other Outcome Measures

Rate of placement to skilled nursing facility after hospital discharge [13 weeks after hospital discharge]
Rate of placement to skilled nursing facility postoperatively
Rate of 90 day hospital readmission after hospital discharge [90 days after hospital discharge]
Rate of 90 day hospital readmission
Rate of postoperative complications [Immediately after the surgery to 3 months postoperatively]
Rate of complications after the surgery
Rate of postoperative delirium [Immediately after the surgery to 3 months postoperatively]
Rate of delirium after the surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center	Philadelphia	Pennsylvania	United States	19104
2	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daniel Lee, MD, MS, Principal Investigator, University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT04314778

Other Study ID Numbers:

833829

First Posted:

Mar 19, 2020

Last Update Posted:

Feb 1, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Study Results

No Results Posted as of Feb 1, 2022