Fitbit and Social Support in Knee Replacement Patients & Buddies

NCT03037619 | Completed Results

• 1 other identifier: Pro00063842
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Moderate/Vigorous Intensity Physical Activity

  Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit

  4 months

Secondary Outcomes (3)

• Social Support

  4 months

• Percentage of Participants Satisfied With the Fitbit

  4 months

• Fitbit Engagement

  4 months

Study Arms (2)

Fitbit

EXPERIMENTAL

Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.

Behavioral: Fitbit

Fitbit+Support

EXPERIMENTAL

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

Interventions

Fitbit BEHAVIORAL

Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months

Fitbit

Fitbit+Support BEHAVIORAL

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Knee replacement patients will be excluded if they have another knee replacement scheduled within the next 4 months.

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Results Point of Contact

• Title: Christine Pellegrini
• Organization: University of South Carolina

cpellegrini@sc.edu

803-777-0911

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: January 31, 2017
• Study Start: March 6, 2017
• Primary Completion: November 10, 2018
• Study Completion: November 10, 2018
• Last Updated: September 16, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)