Trial Outcomes & Findings for Fitbit and Social Support in Knee Replacement Patients & Buddies (NCT NCT03037619)
NCT ID: NCT03037619
Last Updated: 2019-09-16
Results Overview
Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
4 months
Results posted on
2019-09-16
Participant Flow
Participant milestones
| Measure |
Fitbit
Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months
|
Fitbit+Support
Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
15
|
|
Overall Study
COMPLETED
|
8
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Fitbit
Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months
|
Fitbit+Support
Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Fitbit and Social Support in Knee Replacement Patients & Buddies
Baseline characteristics by cohort
| Measure |
Fitbit
n=8 Participants
Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months
|
Fitbit&Support
n=8 Participants
Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 7.6 • n=93 Participants
|
62.5 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
60.6 years
STANDARD_DEVIATION 8.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
8 participants
n=4 Participants
|
8 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: "Buddy participants" (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses
Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit
Outcome measures
| Measure |
Fitbit
n=8 Participants
Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months
|
Fitbit+Support
n=7 Participants
Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
|
|---|---|---|
|
Moderate/Vigorous Intensity Physical Activity
|
26.9 minutes/day
Standard Deviation 28.4
|
33.1 minutes/day
Standard Deviation 32.7
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: "Buddy participants" (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses
Social Support \& Exercise Survey - Family score (sum items 11 - 16 and 20 - 23); Scores can range between 10-50, with a higher score indicating more support
Outcome measures
| Measure |
Fitbit
n=8 Participants
Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months
|
Fitbit+Support
n=7 Participants
Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
|
|---|---|---|
|
Social Support
|
16.6 score on a scale
Standard Deviation 7.9
|
25.0 score on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: "Buddy participants" (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses
Acceptability of the Fitbit (% satisfied with Fitbit)
Outcome measures
| Measure |
Fitbit
n=8 Participants
Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months
|
Fitbit+Support
n=7 Participants
Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
|
|---|---|---|
|
Percentage of Participants Satisfied With the Fitbit
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: "Buddy participants" (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses
Percentage of days Fitbit was worn
Outcome measures
| Measure |
Fitbit
n=8 Participants
Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.
Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months
|
Fitbit+Support
n=7 Participants
Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
|
|---|---|---|
|
Fitbit Engagement
|
88.9 Percentage of days
Standard Deviation 13.2
|
99.3 Percentage of days
Standard Deviation 1.3
|
Adverse Events
Fitbit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fitbit+Support
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place