Fitbit and Social Support in Knee Replacement Patients & Buddies

NCT ID: NCT03037619

Last Updated: 2019-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-06
• Study Completion Date: 2018-11-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Fitbit

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

Group Type: EXPERIMENTAL

Fitbit

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Fitbit+Support

Intervention Type: 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.

Interventions

Fitbit

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Christine A Pellegrini, PhD

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of South Carolina

Columbia, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00063842

Identifier Type: -

Identifier Source: org_study_id