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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

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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Behavioral: Fitbit Behavioral: Fitbit+Support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Influence of Wearable Activity Monitors and Social Support on Physical Activity After Knee Replacement
Actual Study Start Date : March 6, 2017
Actual Primary Completion Date : November 10, 2018
Actual Study Completion Date : November 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fitbit
Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.
Behavioral: Fitbit
Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months

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.
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.




Primary Outcome Measures :
  1. Moderate/Vigorous Intensity Physical Activity [ Time Frame: 4 months ]
    Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit


Secondary Outcome Measures :
  1. 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

  2. Percentage of Participants Satisfied With the Fitbit [ Time Frame: 4 months ]
    Acceptability of the Fitbit (% satisfied with Fitbit)

  3. Fitbit Engagement [ Time Frame: 4 months ]
    Percentage of days Fitbit was worn



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037619


Locations
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United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
  Study Documents (Full-Text)

Documents provided by Christine A Pellegrini, PhD, University of South Carolina:

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Responsible Party: Christine A Pellegrini, PhD, Research Assistant Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT03037619     History of Changes
Other Study ID Numbers: Pro00063842
First Posted: January 31, 2017    Key Record Dates
Results First Posted: September 16, 2019
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No