Technology Interventions to Improve Outcomes After Knee Replacement

Not Applicable

Completed

• Conditions: Knee Arthroplasty
• Interventions: Behavioral: MyKneeGuide; Behavioral: NEAT!2

• Registration Number: NCT04482400
• Lead Sponsor: University of South Carolina

Brief Summary

The purpose of this study is to examine the effects of two technology interventions on health outcomes (e.g., physical activity, sedentary behavior, physical function, pain) after knee replacement at 2 and 5 months .

Detailed Description

Two 8 week technology interventions will be examined and consist of the use of an app and/or website and regular calls. Assessments to examine outcomes will be completed at baseline, as well as at 2 and 5 months.

Study Timeline

• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-22
• Study Start: 2020-08-01
• Primary Completion: 2024-10-25
• Study Completion: 2024-10-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Be 40-79 years of age
• Had unilateral knee replacement within last 12 months
• Have an Android or iOS smartphone that is accessible and near them the majority of the day
• Be willing to download the study applications on their smartphone
• Spend at least 7 hours/day sitting
• Be English speaking

Exclusion Criteria

• Have any contraindications to activity
• Have a mobility limiting comorbidity
• Have a scheduled surgery within the next 6 months
• Do not have ≥4 days of valid accelerometer (>=10 hours) wear at baseline.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MyKneeGuide	MyKneeGuide	Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.
NEAT!2	NEAT!2	Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.

Primary Outcome Measures

Name	Time	Method
Change in Objectively Measured (Actigraph) Sedentary Behavior at 5 months	5 months - baseline	change in sedentary behavior (\<100 counts/minute) measured with Actigraph accelerometers between baseline and 6 months
Change in Objectively Measured (Actigraph) Sedentary Behavior at 2 months	2 months - baseline	change sedentary behavior (\<100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months

Secondary Outcome Measures

Name	Time	Method
Change in WOMAC Pain Subscale	5 months after surgery	WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)
Total physical activity measured by Actigraph accelerometers	5 months after surgery	objectively measured light, moderate and vigorous activity (\>= 100 counts/min) by Actigraph accelerometers
Change in physical function via chair stand test	5 months after surgery	Chair stand test
Change in Physical Function	5 months after surgery	Six minute walk test
Adherence to NEAT!2 calls	2 months	Number of calls completed
Adherence to NEAT!2 app	2 months	total days NEAT! app was used
Response to NEAT!2 prompts	2 months	percentage of notifications in which a transition from sitting to standing was detected

Trial Locations

Locations (1)

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States