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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

Tracking Information
First Submitted Date  ICMJE January 27, 2017
First Posted Date  ICMJE January 31, 2017
Results First Submitted Date  ICMJE July 25, 2019
Results First Posted Date  ICMJE September 16, 2019
Last Update Posted Date September 16, 2019
Actual Study Start Date  ICMJE March 6, 2017
Actual Primary Completion Date November 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
Moderate/Vigorous Intensity Physical Activity [ Time Frame: 4 months ]
Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
Moderate/Vigorous Intensity Physical Activity [ Time Frame: 4 months ]
Number of minutes
Change History Complete list of historical versions of study NCT03037619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
  • Social Support [ Time Frame: 4 months ]
    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
  • Percentage of Participants Satisfied With the Fitbit [ Time Frame: 4 months ]
    Acceptability of the Fitbit (% satisfied with Fitbit)
  • Fitbit Engagement [ Time Frame: 4 months ]
    Percentage of days Fitbit was worn
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
  • Social Support [ Time Frame: 4 months ]
    Social Support & Exercise Survey
  • Fitbit Acceptability [ Time Frame: 4 months ]
    Acceptability of the Fitbit
  • Fitbit Engagement [ Time Frame: 4 months ]
    Percentage of days Fitbit was worn
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fitbit and Social Support in Knee Replacement Patients & Buddies
Official Title  ICMJE Influence of Wearable Activity Monitors and Social Support on Physical Activity After Knee Replacement
Brief Summary Patients undergoing knee replacement typically report improved health-related quality of life, increased physical function, and reduced pain. Despite these improvements, physical activity levels remain unchanged, or only minimally increase from pre-operative levels, yet do not reach the same level of activity observed among healthy populations. Knee replacement patients often expect their activity levels and function to improve following surgery, but the majority of patients' activity levels 5 years post-operatively did not meet their pre-operative expectations. Even though improvements are observed in pain and function, reasons for the maintenance of low levels of activity are unknown. Technology has the potential to increase physical activity levels in these patients, particularly as 81% of knee replacement patients in our recent study had a smartphone, and 40% were willing to wear a wrist-worn physical activity monitor. As the average age of knee replacement continues to decrease, we anticipate that the percent of patients with a smartphone and willingness to wear an activity monitor will increase. In addition to technology, social support is associated with greater outcomes following knee replacement. Thus, wearing a wrist-worn physical activity monitor and providing additional opportunities for social support via the technology may increase physical activity levels in these patients. The current pilot study aims to gain preliminary data on the influence of wearables and social support on physical activity in knee replacement patients following surgery. Specifically, we aim to recruit 20 patients who will be randomized to one of two conditions: Fitbit vs. Fitbit+Support. Participants in the Fitbit group will receive a Fitbit and be encouraged to wear it for 4 months. Participants in the Fitbit+Support group will be asked to identify a "buddy." Both the participant and "buddy" will be given a Fitbit and they will be asked to friend each other via Fitbit and wear the monitor for 4 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Arthroplasty, Replacement, Knee
Intervention  ICMJE
  • Behavioral: Fitbit
    Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: Fitbit
    Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.
    Intervention: Behavioral: Fitbit
  • Experimental: 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.
    Intervention: Behavioral: Fitbit+Support
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2018)
23
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2017)
30
Actual Study Completion Date  ICMJE November 10, 2018
Actual Primary Completion Date November 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Knee replacement patients must (1) have had a knee replacement in the last 12 months; (2) have a computer or smartphone compatible with Fitbit, (3) be English speaking, (4) willing to wear the Fitbit for 4 months, and (5) have a "buddy" willing to participate.
  • Patient buddies must: (1) have a computer or smartphone compatible with Fitbit, (2) be English speaking, and (3) willing to wear the Fitbit for 4 months.

Exclusion Criteria:

  • Knee replacement patients will be excluded if they have another knee replacement scheduled within the next 4 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03037619
Other Study ID Numbers  ICMJE Pro00063842
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christine A Pellegrini, PhD, University of South Carolina
Study Sponsor  ICMJE University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of South Carolina
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP