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Moving Well for Total Knee Arthroplasty (TKA)

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moving Well
Staying Well
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee focused on measuring arthroplasty, replacement, peer coach

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a primary (first) total knee replacement scheduled in 8 weeks or more.
  • ≥60 years of age
  • Speak English
  • Have access to the internet and a computer
  • Able to travel to New York City (Upper East Side) for in-person data collection visits
  • Low functional status defined as a Knee Injury and Osteoarthritis Outcome Score (KOOS) <45
  • We will prioritize the recruitment of subjects with low socioeconomic status defined as being a beneficiary of Medicaid or no insurance and an underrepresented racial/ethnic group (Hispanic/Black).
  • Have at least one of these two factors: High level of anxiety as defined by the Generalized Anxiety Disorder Assessment (GAD-7) instrument (score ≥10) OR Depression, as assessed by Patient Health Questionnaire depression scale (PHQ-8) (score ≥ 10).

Exclusion Criteria:

  • Non-English speakers
  • Planned total knee replacement is a result of a septic joint or revision (implant malfunction)
  • Unable to exercise (e.g., bed bound)
  • Have had contralateral total knee replacement or other joint replacement surgery (hip, shoulder)
  • Have rheumatoid arthritis or other connective tissue disease: Lupus, ankylosing spondylitis, psoriatic arthritis, scleroderma, infectious arthritis, polymyalgia rheumatica.

Sites / Locations

  • Weill Cornell Medicine Clinical & Translational Science CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moving Well

Staying Well

Arm Description

Participants will receive weekly calls for 12 weeks (7 weeks before total knee arthroplasty surgery and 5 weeks after surgery) from a peer coach, an exercise program, and mental preparation (through positive thinking) for surgery. Participants will also receive the standard of care for patients undergoing total knee arthroplasty.

Participants will receive weekly calls for 12 weeks (7 weeks before total knee arthroplasty surgery and 5 weeks after surgery) from a research assistant. The calls will be similar in length to those in the experimental arm and will cover various health topics not related to total knee arthroplasty. Participants will also receive the standard of care for patients undergoing total knee arthroplasty.

Outcomes

Primary Outcome Measures

Change in level of anxiety from baseline using the Generalized Anxiety Disorder Assessment (GAD-7)
The GAD-7 is a 7 item self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Scores range from 0 to 21, with higher scores indicating greater severity of anxiety.
Change in level of depression from baseline using the Patient Health Questionnaire-8 (PHQ-8)
The PHQ-8 is a 8 item scale that screens for depression. Scores range from 0 to 24 with higher scores indicating greater severity of depression.

Secondary Outcome Measures

Change in level of social support from baseline using the Lubben Social Network Scale-18 (LSNS-18)
The LSNS-18 is a 18 item scale that measures perceived social support. Scores range from 0 to 90 with higher scores indicating greater social engagement.
Change in general health status from baseline using the 12-Item Short Form Survey (SF-12)
The SF-12 is a 12 item scale that assesses general health status. Scores range from 0 to 100 with higher scores indicating better physical and mental health functioning.
Change in level of pain catastrophizing from baseline using the Pain Catastrophizing Scale (PCS).
The PCS is a 13 item scale that assesses the level of catastrophic thinking related to an individual's pain. Scores range from 0 to 52 with higher scores indicating a higher level of pain-related anxiety.
Change in level of knee pain and function from baseline using the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale.
The KOOS pain sub-scale is a 9 item scale that assesses knee pain. Scores range from 0 to 100 with lower scores indicating greater severity of pain. The KOOS function sub-scale is a 17 item scale that assesses function. Scores range from 0 to 100 with lower scores indicating worse knee function.
Change in level of self-efficacy from baseline using the General Self-Efficacy Scale (GSF)
The GSF is a 10 item scale that assesses perceived self-efficacy. Scores range from 10 to 40 with higher scores indicating a higher level of self-efficacy.
Change in sleep disturbance from baseline using the Patient-Reported Outcomes Information System (PROMIS) Sleep Disturbance Scale.
The PROMIS Sleep Disturbance Scale is a 8 item scale that measure self-reported perceptions of sleep quality, depth, and restoration within the past seven days. Scores range from with higher scores indicating greater sleep disturbances.
Change in opioid use for knee pain from baseline using participant self-report
Self-reported use of opioids for knee pain
Duration of post-surgery inpatient rehabilitation using the number of days of inpatient rehabilitation
Self-reported duration of inpatient rehabilitation
Change in knee range of motion from baseline using a goniometer
A goniometer measures the range of motion at a joint. Measurement ranges from 0 to 180 degrees with higher range indicating greater range of motion.
Change in Timed Up and Go test (TUG) from baseline
The Timed Up and Go test is used to assess mobility. Completing the test in more than 12 seconds indicates a greater risk of falling in older adults.
Change in 6-minute walk test (6MWT) from baseline
The 6MWT is used to assess aerobic capacity and endurance. The distance covered by walking for 6 minutes is measured and used to compare changes in performance capacity.
Change in 30-second chair to stand test from baseline
The 30-second chair to stand test assesses leg strength and endurance. Scoring is based on the number of stands with a lower than average number indicating a greater risk of falls.
Change in quadriceps strength from baseline using a handheld dynamometer (HHD)
A handheld dynamometer is a device that measures muscle strength. Scores range from 0-300 pounds (upper limit can vary based on the device) with higher scores indicating greater quadriceps muscle strength.

Full Information

First Posted
January 31, 2022
Last Updated
April 17, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Rheumatology Research Foundation, Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT05217420
Brief Title
Moving Well for Total Knee Arthroplasty (TKA)
Official Title
Moving Well Intervention for Patients Preparing to Undergo Total Knee Arthroplasty (TKA)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Rheumatology Research Foundation, Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy of a behavioral intervention, Moving Well, in improving levels of anxiety and depression for patients undergoing total knee arthroplasty (TKA).
Detailed Description
Moving Well is a behavioral intervention, guided by peer coaches, that aims to improve mental and physical preparation for patients planning to undergo total knee arthroplasty (TKA) and improve postoperative recovery and outcomes. Peer coaches are patients who themselves have had TKA due to advanced osteoarthritis (OA) of the knee and have been trained and certified to become peer coaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
arthroplasty, replacement, peer coach

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Only research team members who will collect objective in-person data will be masked
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moving Well
Arm Type
Experimental
Arm Description
Participants will receive weekly calls for 12 weeks (7 weeks before total knee arthroplasty surgery and 5 weeks after surgery) from a peer coach, an exercise program, and mental preparation (through positive thinking) for surgery. Participants will also receive the standard of care for patients undergoing total knee arthroplasty.
Arm Title
Staying Well
Arm Type
Active Comparator
Arm Description
Participants will receive weekly calls for 12 weeks (7 weeks before total knee arthroplasty surgery and 5 weeks after surgery) from a research assistant. The calls will be similar in length to those in the experimental arm and will cover various health topics not related to total knee arthroplasty. Participants will also receive the standard of care for patients undergoing total knee arthroplasty.
Intervention Type
Behavioral
Intervention Name(s)
Moving Well
Intervention Description
Experimental arm
Intervention Type
Behavioral
Intervention Name(s)
Staying Well
Intervention Description
Active comparator arm
Primary Outcome Measure Information:
Title
Change in level of anxiety from baseline using the Generalized Anxiety Disorder Assessment (GAD-7)
Description
The GAD-7 is a 7 item self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Scores range from 0 to 21, with higher scores indicating greater severity of anxiety.
Time Frame
Baseline, 6 months post-surgery
Title
Change in level of depression from baseline using the Patient Health Questionnaire-8 (PHQ-8)
Description
The PHQ-8 is a 8 item scale that screens for depression. Scores range from 0 to 24 with higher scores indicating greater severity of depression.
Time Frame
Baseline, 6 months post-surgery
Secondary Outcome Measure Information:
Title
Change in level of social support from baseline using the Lubben Social Network Scale-18 (LSNS-18)
Description
The LSNS-18 is a 18 item scale that measures perceived social support. Scores range from 0 to 90 with higher scores indicating greater social engagement.
Time Frame
Baseline, 6 months post-surgery
Title
Change in general health status from baseline using the 12-Item Short Form Survey (SF-12)
Description
The SF-12 is a 12 item scale that assesses general health status. Scores range from 0 to 100 with higher scores indicating better physical and mental health functioning.
Time Frame
Baseline, 6 months post-surgery
Title
Change in level of pain catastrophizing from baseline using the Pain Catastrophizing Scale (PCS).
Description
The PCS is a 13 item scale that assesses the level of catastrophic thinking related to an individual's pain. Scores range from 0 to 52 with higher scores indicating a higher level of pain-related anxiety.
Time Frame
Baseline, 6 months post-surgery
Title
Change in level of knee pain and function from baseline using the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale.
Description
The KOOS pain sub-scale is a 9 item scale that assesses knee pain. Scores range from 0 to 100 with lower scores indicating greater severity of pain. The KOOS function sub-scale is a 17 item scale that assesses function. Scores range from 0 to 100 with lower scores indicating worse knee function.
Time Frame
Baseline, 6 months post-surgery
Title
Change in level of self-efficacy from baseline using the General Self-Efficacy Scale (GSF)
Description
The GSF is a 10 item scale that assesses perceived self-efficacy. Scores range from 10 to 40 with higher scores indicating a higher level of self-efficacy.
Time Frame
Baseline, 6 months post-surgery
Title
Change in sleep disturbance from baseline using the Patient-Reported Outcomes Information System (PROMIS) Sleep Disturbance Scale.
Description
The PROMIS Sleep Disturbance Scale is a 8 item scale that measure self-reported perceptions of sleep quality, depth, and restoration within the past seven days. Scores range from with higher scores indicating greater sleep disturbances.
Time Frame
Baseline, 6 months post-surgery
Title
Change in opioid use for knee pain from baseline using participant self-report
Description
Self-reported use of opioids for knee pain
Time Frame
Baseline, 6 months post-surgery
Title
Duration of post-surgery inpatient rehabilitation using the number of days of inpatient rehabilitation
Description
Self-reported duration of inpatient rehabilitation
Time Frame
6 months post-surgery
Title
Change in knee range of motion from baseline using a goniometer
Description
A goniometer measures the range of motion at a joint. Measurement ranges from 0 to 180 degrees with higher range indicating greater range of motion.
Time Frame
Baseline, 6 months post-surgery
Title
Change in Timed Up and Go test (TUG) from baseline
Description
The Timed Up and Go test is used to assess mobility. Completing the test in more than 12 seconds indicates a greater risk of falling in older adults.
Time Frame
Baseline, 6 months post-surgery
Title
Change in 6-minute walk test (6MWT) from baseline
Description
The 6MWT is used to assess aerobic capacity and endurance. The distance covered by walking for 6 minutes is measured and used to compare changes in performance capacity.
Time Frame
Baseline, 6 months post-surgery
Title
Change in 30-second chair to stand test from baseline
Description
The 30-second chair to stand test assesses leg strength and endurance. Scoring is based on the number of stands with a lower than average number indicating a greater risk of falls.
Time Frame
Baseline, 6 months post-surgery
Title
Change in quadriceps strength from baseline using a handheld dynamometer (HHD)
Description
A handheld dynamometer is a device that measures muscle strength. Scores range from 0-300 pounds (upper limit can vary based on the device) with higher scores indicating greater quadriceps muscle strength.
Time Frame
Baseline, 6 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have their primary TKR (one knee or both knees) scheduled in 8 weeks or more Be willing to participate in the Moving Well (intervention) arm or Staying Well (attention control) arm Are willing to work with a coach ≥ 50 years of age Speak English Have access to the internet, computer, and a working phone We will prioritize the recruitment of subjects with low socioeconomic status defined as being a beneficiary of Medicaid or no insurance and an underrepresented racial/ethnic group (Hispanic/Black). Exclusion Criteria: Non-English speakers The intervention will first be delivered in English to ensure feasibility with the content before adapting the material for patients who speak other languages. TKR was a result of a septic joint or revision (implant malfunction) Unable to exercise (e.g., bed bound or wheelchair bound) Have had contralateral TKR or other joint replacement surgery (hip, shoulder) within the past 5 years If they have RA or other connective tissue disease: Lupus, ankylosing spondylitis, psoriatic arthritis, scleroderma, infectious arthritis, polymyalgia rheumatica.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuliana Dominguez Paez, BS
Phone
646-962-6407
Email
yud4001@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Noelia Hernandez, BS
Phone
646-962-5888
Email
noh4005@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Y Navarro Millan, MD, MSPH
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine Clinical & Translational Science Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris Y Navarro Millan, MD, MSPH
Phone
646-962-5896
Email
yin9003@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Iris Y Navarro Millan, MD, MSPH

12. IPD Sharing Statement

Plan to Share IPD
No

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Moving Well for Total Knee Arthroplasty (TKA)

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