Trial Outcomes & Findings for Steps to Eliminate Postoperative Problems (NCT NCT02880176)

Results Overview

Number of days during the study period that each subject reaches their step goal

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

30 days

Results posted on

2021-03-09

Participant Flow

Exceeded recruitment goal.

Participant milestones

Participant milestones
Measure	Financial Incentive Financial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days. Subjects will use Fitbit Zip to track step counts	Control (Education) Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts
Overall Study STARTED	23	11
Overall Study Underwent Cystectomy	22	11
Overall Study Collected Postop Step Data	22	11
Overall Study Responded to 30 Day Survey	20	9
Overall Study COMPLETED	20	9
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Financial Incentive n=22 Participants Financial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days. Subjects will use Fitbit Zip to track step counts	Control (Education) n=11 Participants Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts	Total n=33 Participants Total of all reporting groups
Age, Continuous	64.5 years n=22 Participants	65 years n=11 Participants	65 years n=33 Participants
Sex: Female, Male Female	1 Participants n=22 Participants	2 Participants n=11 Participants	3 Participants n=33 Participants
Sex: Female, Male Male	21 Participants n=22 Participants	9 Participants n=11 Participants	30 Participants n=33 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 30 days

Number of days during the study period that each subject reaches their step goal

Outcome measures

Outcome measures
Measure	Financial Incentive n=22 Participants Financial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days. Subjects will use Fitbit Zip to track step counts	Control (Education) n=11 Participants Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts
Number of Days Step Goal Completed	4.5 days Interval 0.0 to 16.0	9 days Interval 6.0 to 15.0

SECONDARY outcome

Timeframe: 30 days

Average number of steps taken per day in the 30 day postoperative period. Note that the average number of steps taken per day is calculated separately for each patient as simply (total number of steps taken in the 30 day postoperative period)/30. For the purposes of comparing the two study groups, nonparametric tests and medians are used. Thus the "measure type" listed in the "Outcome Measure Data Table" is correctly listed as "median". For example, in the Financial Incentive arm, we report a median average number of steps per day as 979, implying that half of the patients walked fewer than 979 steps on an average day and half of the patients walked more than 979 steps on an average day in that group.

Outcome measures

Outcome measures
Measure	Financial Incentive n=22 Participants Financial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days. Subjects will use Fitbit Zip to track step counts	Control (Education) n=11 Participants Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts
Number of Steps Taken Per Day	979 steps per day Interval 505.0 to 2646.0	1191 steps per day Interval 788.0 to 1846.0

SECONDARY outcome

Timeframe: 30 days

Population: Protocol revised to remove this outcome. No data collected.

Binary variable reflecting whether or not patient suffered any of the following: any postoperative complication, any unplanned readmission, any presentation to the emergency department within 30 days after surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 months

30-day postoperative Stanford Health Assessment Questionnaire Disability Index (SHAQ) score, indicating subjects ability to perform daily tasks. Scores range continuously from 0-4 representing no disability to complete disability respectively. Scores \>2 are usually considered severe disability. The total score is computed as the mean of 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each category consists of a list of 2-3 actions. The participant selects whether they are able to perform each action "without any difficulty", "with some difficulty", "with much difficulty", or "unable to do". These selections are scored 0-4 respectively. The category is assigned the maximum score of its component actions. If the subject requires assistance from a person or device for an individual action, the minimum score for that action is 2.

Outcome measures

Outcome measures
Measure	Financial Incentive n=20 Participants Financial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days. Subjects will use Fitbit Zip to track step counts	Control (Education) n=9 Participants Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts
Functional Decline as Assessed by the Stanford Health Assessment Questionnaire (SHAQ)	1.25 units on a scale Interval 1.0 to 1.5	1.38 units on a scale Interval 1.1 to 1.8

Adverse Events

Financial Incentive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control (Education)

Serious events: 0 serious events

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

Dr. Marshall Strother

Fox Chase Cancer Center

Phone: 555-555-5555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place