Trial Outcomes & Findings for FITBIT Study on Mobility and Readmissions After Radical Cystectomy (NCT NCT04314778)

Results Overview

Change in mean daily step count

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

64 participants

Primary outcome timeframe

From baseline step count after a two-day run-in period after the surgery to the time of hospital discharge postoperatively. As the time to discharge was variable, this time period was up to 60 days after surgery

Results posted on

2024-12-24

Participant Flow

64 participants gave informed consent but 3 participants declined to complete required pre-randomization surveys. These participants were not assigned to intervention or control groups and were excluded from the study.

Participant milestones

Participant milestones
Measure	Intervention Participants in the intervention arm will have a postoperative daily step goal that increases from baseline by 500 steps each day. 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).	Control Participants in the control group will have data collected passively via Fitbit.
Overall Study STARTED	30	31
Overall Study COMPLETED	25	28
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Participants in the intervention arm will have a postoperative daily step goal that increases from baseline by 500 steps each day. 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).	Control Participants in the control group will have data collected passively via Fitbit.
Overall Study Lost to Follow-up	5	3

Baseline Characteristics

64 patients gave informed consent but only 61 completed run-in and were randomized.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=30 Participants Participants in the intervention arm will have a postoperative daily step goal that increases from baseline by 500 steps each day. 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).	Control n=31 Participants Participants in the control group will have data collected passively via Fitbit.	Total n=61 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 10.2 • n=5 Participants • 64 patients gave informed consent but only 61 completed run-in and were randomized.	67 years STANDARD_DEVIATION 12.4 • n=7 Participants • 64 patients gave informed consent but only 61 completed run-in and were randomized.	66.2 years STANDARD_DEVIATION 11.3 • n=5 Participants • 64 patients gave informed consent but only 61 completed run-in and were randomized.
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized Black, non-Hispanic	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline step count after a two-day run-in period after the surgery to the time of hospital discharge postoperatively. As the time to discharge was variable, this time period was up to 60 days after surgery

Population: Only 23 participants had recorded step count data of more than two days while in the hospital. This clinical trial was performed during the height of the COVID-19 pandemic when research staff and hospital staff were not allowed in the hospital or on University campuses, making follow up in the hospital difficult while patients were recovering from a major surgery

Change in mean daily step count

Outcome measures

Outcome measures
Measure	Intervention n=8 Participants Participants in the intervention arm will have a postoperative daily step goal that increases from baseline by 500 steps each day. 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).	Control n=15 Participants Participants in the control group will have data collected passively via Fitbit.
Change in Mean Daily Step Count From the Baseline Step Count During Two Days After the Surgery to the Hospital Discharge	1087 mean change in daily steps Interval 652.0 to 1521.0	995 mean change in daily steps Interval 185.0 to 1806.0

SECONDARY outcome

Timeframe: From the postoperative baseline step count during 2 day run-in to 3 months after discharge from the hospital. This time was up to 3 months after discharge

Change in mean daily step count

Outcome measures

Outcome measures
Measure	Intervention n=25 Participants Participants in the intervention arm will have a postoperative daily step goal that increases from baseline by 500 steps each day. 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).	Control n=28 Participants Participants in the control group will have data collected passively via Fitbit.
Change in Mean Daily Step Count From the Postoperative Baseline to 3 Months After Discharge From the Hospital	5674 mean change in daily steps Standard Deviation 3681	4660 mean change in daily steps Standard Deviation 3063

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks after hospital discharge

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

S. Ryan Greysen, MD (Principal Investigator)

University of Pennsylvania

Phone: 215-614-0095

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place