Technology Interventions to Improve Outcomes After Knee Replacement

NCT04482400 | Completed Results DMC

• 1 other identifier: Pro00092132
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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 .

Conditions

Knee Arthroplasty

Outcome Measures

Primary Outcomes (2)

• Objectively Measured (Actigraph) Sedentary Behavior at 2 Months

  sedentary behavior (\<100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months

  2 months

• Objectively Measured (Actigraph) Sedentary Behavior at 5 Months

  sedentary behavior (\<100 counts/minute) measured with Actigraph accelerometers between baseline and 6 months

  5 months

Secondary Outcomes (7)

• Physical Function

  5 months after surgery

• WOMAC Pain Subscale

  5 months after surgery

• Total Physical Activity Measured by Actigraph Accelerometers

  5 months after surgery

• Adherence to Calls

  2 months

• Adherence to NEAT!2 App

  2 months

Other Outcomes (11)

• Physical Function Via Timed up and go

  5 months after surgery

• Knee Symptoms - KOOS Pain

  5 months

• Knee Symptoms - KOOS Symptoms

  2 months

Study Arms (2)

NEAT!2

EXPERIMENTAL

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.

Behavioral: NEAT!2

MyKneeGuide

ACTIVE COMPARATOR

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.

Behavioral: MyKneeGuide

Interventions

MyKneeGuide BEHAVIORAL

8 week surgery recovery education program

MyKneeGuide

NEAT!2 BEHAVIORAL

8 week sedentary reduction program

NEAT!2

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prisma Health-Midlands: collaborator
• University of South Carolina: lead
• Northwestern University: collaborator

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

pellegca@mailbox.sc.edu

803-777-0911

Study Officials

• Christine Pellegrini, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 22, 2020
• Study Start: August 1, 2020
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after primary manuscripts are published

Locations

US (1)