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Fitbit and Social Support in Knee Replacement Patients & Buddies

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ClinicalTrials.gov Identifier: NCT03037619
Recruitment Status : Completed
First Posted : January 31, 2017
Results First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Christine A Pellegrini, PhD, University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Arthroplasty, Replacement, Knee
Interventions Behavioral: Fitbit
Behavioral: Fitbit+Support
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fitbit Fitbit+Support
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 8 15 [1]
Completed 8 14 [2]
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
[1]
8 participants and 7 buddies
[2]
7 participants and 7 buddies
Arm/Group Title Fitbit Fitbit&Support Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
"Buddy participants" (n=7) were excluded from baseline analyses. Only knee replacement participants were included (n=8).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  75.0%
4
  50.0%
10
  62.5%
>=65 years
2
  25.0%
4
  50.0%
6
  37.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
58.6  (7.6) 62.5  (8.5) 60.6  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
8
 100.0%
5
  62.5%
13
  81.3%
Male
0
   0.0%
3
  37.5%
3
  18.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
8
 100.0%
8
 100.0%
16
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  12.5%
1
   6.3%
White
8
 100.0%
7
  87.5%
15
  93.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8 8 8
1.Primary Outcome
Title Moderate/Vigorous Intensity Physical Activity
Hide Description Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
"Buddy participants" (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses
Arm/Group Title Fitbit Fitbit+Support
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: minutes/day
26.9  (28.4) 33.1  (32.7)
2.Secondary Outcome
Title Social Support
Hide Description 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
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
"Buddy participants" (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses
Arm/Group Title Fitbit Fitbit+Support
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: score on a scale
16.6  (7.9) 25.0  (12.2)
3.Secondary Outcome
Title Percentage of Participants Satisfied With the Fitbit
Hide Description Acceptability of the Fitbit (% satisfied with Fitbit)
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
"Buddy participants" (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses
Arm/Group Title Fitbit Fitbit+Support
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 8 7
Measure Type: Count of Participants
Unit of Measure: Participants
7
  87.5%
6
  85.7%
4.Secondary Outcome
Title Fitbit Engagement
Hide Description Percentage of days Fitbit was worn
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
"Buddy participants" (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses
Arm/Group Title Fitbit Fitbit+Support
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: Percentage of days
88.9  (13.2) 99.3  (1.3)
Time Frame 4 months
Adverse Event Reporting Description This study was classified as minimal risk to participants.
 
Arm/Group Title Fitbit Fitbit+Support
Hide Arm/Group Description

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

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.

All-Cause Mortality
Fitbit Fitbit+Support
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Fitbit Fitbit+Support
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fitbit Fitbit+Support
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christine Pellegrini
Organization: University of South Carolina
Phone: 803-777-0911
EMail: cpellegrini@sc.edu
Layout table for additonal information
Responsible Party: Christine A Pellegrini, PhD, University of South Carolina
ClinicalTrials.gov Identifier: NCT03037619     History of Changes
Other Study ID Numbers: Pro00063842
First Submitted: January 27, 2017
First Posted: January 31, 2017
Results First Submitted: July 25, 2019
Results First Posted: September 16, 2019
Last Update Posted: September 16, 2019