Technology Interventions to Improve Outcomes After Knee Replacement

Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04482400
• Other study ID #: Pro00092132
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: March 2024
• Source: University of South Carolina
• Contact: Ellen Wingard
• Phone: 803-777-1889
• Email: ewingard[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

Behavioral:
• NEAT!2
8 week sedentary reduction program
• MyKneeGuide
8 week surgery recovery education program

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of South Carolina	Northwestern University, Prisma Health-Midlands

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in physical function via timed up and go	Timed up and go test	5 months after surgery
Other	Change in Knee Symptoms - KOOS pain	KOOS pain subcale (0 indicates extreme problems, 100 no problems)	5 months
Other	Change in Knee Symptoms - KOOS symptoms	KOOS symptoms subcale (0 indicates extreme problems, 100 no problems)	2 months
Other	Change in Knee Symptoms - KOOS ADL	KOOS ADL subcale (0 indicates extreme problems, 100 no problems)	5 months
Other	Change in Knee Symptoms - KOOS sport/rec	KOOS sport/rec subcale (0 indicates extreme problems, 100 no problems)	5 months
Other	Change in Knee Symptoms - KOOS QoL	KOOS QOL subcales (0 indicates extreme problems, 100 no problems)	5 months
Other	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
Other	Change in sedentary time via activPAL accelerometers	activPAL accelerometer	5 months
Other	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
Other	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
Other	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
Other	Change in habit strength	adapted self-report habit index	5 months
Other	Change in sedentary time via SIT-Q	SIT-Q	5 months
Other	Weight	Change in weight	5 months
Primary	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
Primary	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	Change in Physical Function	Six minute walk test	5 months after surgery
Secondary	Change in WOMAC Pain Subscale	WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)	5 months after surgery
Secondary	Total physical activity measured by Actigraph accelerometers	objectively measured light, moderate and vigorous activity (>= 100 counts/min) by Actigraph accelerometers	5 months after surgery
Secondary	Adherence to NEAT!2 calls	Number of calls completed	2 months
Secondary	Adherence to NEAT!2 app	total days NEAT! app was used	2 months
Secondary	Response to NEAT!2 prompts	percentage of notifications in which a transition from sitting to standing was detected	2 months
Secondary	Change in physical function via chair stand test	Chair stand test	5 months after surgery