Technology Interventions to Improve Outcomes After Knee Replacement

Reducing Sedentary Time Using an Innovative mHealth Intervention Among Total Knee Replacement Patients

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 .

Study Overview

• Status: Recruiting
• Conditions: Knee Arthroplasty
• Intervention / Treatment: Behavioral: NEAT!2; Behavioral: MyKneeGuide

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 Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellen Wingard; Phone Number: 803-777-1889; Email: ewingard@mailbox.sc.edu

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • Recruiting
      • University of South Carolina
      • Contact: Christine Pellegrini, PhD.; Phone Number: 803-777-0911; Email: cpellegrini@sc.edu
      • Principal Investigator: Christine Pellegrini, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: NEAT!2; 8 week sedentary reduction program
Active Comparator: 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.	Behavioral: MyKneeGuide; 8 week surgery recovery education program

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical function via timed up and go	Timed up and go test	5 months after surgery
Change in Knee Symptoms - KOOS pain	KOOS pain subcale (0 indicates extreme problems, 100 no problems)	5 months
Change in Knee Symptoms - KOOS symptoms	KOOS symptoms subcale (0 indicates extreme problems, 100 no problems)	2 months
Change in Knee Symptoms - KOOS ADL	KOOS ADL subcale (0 indicates extreme problems, 100 no problems)	5 months
Change in Knee Symptoms - KOOS sport/rec	KOOS sport/rec subcale (0 indicates extreme problems, 100 no problems)	5 months
Change in Knee Symptoms - KOOS QoL	KOOS QOL subcales (0 indicates extreme problems, 100 no problems)	5 months
Change in knee symptoms via WOMAC	WOMAC total score (pain, stiffness, and function) - Scores range from 0 (no problems) to 96 (extreme problems)	5 months
Change in sedentary time via activPAL accelerometers	activPAL accelerometer	5 months
Patient Reported outcomes - Mobility - T-Score	Patient-Reported Outcomes Measurement Information System (PROMIS) - T score of 50 represents average for general population (scores higher than 50 represent better function and mobility)	5 months
Patient Reported outcomes - global health - T-Score	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - T score of 50 represents average for general population (scores higher than 50 represent better health)	5 months
Patient Reported outcomes - sleep disturbance - T-Score	Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance - T score of 50 represents average for general population (scores higher than 50 represent worse sleep disturbance)	5 months
Change in habit strength	adapted self-report habit index	5 months
Change in sedentary time via SIT-Q	SIT-Q	5 months
Weight	Change in weight	5 months

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: Northwestern University; Prisma Health-Midlands
• Investigators: Principal Investigator: Christine Pellegrini, PhD, University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Pro00092132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified study data will be made available 12 months after the primary manuscript is published.
• IPD Sharing Time Frame: 12 months after primary manuscripts are published
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No