Moving Well for Total Knee Arthroplasty (TKA)

NCT05217420 | Active Not Recruiting

• 1 other identifier: 19-08020638
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Knee

Keywords

arthroplasty; replacement; peer coach

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 6 months post-surgery

• 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.

  Baseline, 6 months post-surgery

Secondary Outcomes (13)

• Change in level of social support from baseline using the Lubben Social Network Scale-18 (LSNS-18)

  Baseline, 6 months post-surgery

• Change in general health status from baseline using the 12-Item Short Form Survey (SF-12)

  Baseline, 6 months post-surgery

• Change in level of pain catastrophizing from baseline using the Pain Catastrophizing Scale (PCS).

  Baseline, 6 months post-surgery

• Change in level of knee pain and function from baseline using the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale.

  Baseline, 6 months post-surgery

• Change in level of self-efficacy from baseline using the General Self-Efficacy Scale (GSF)

  Baseline, 6 months post-surgery

Study Arms (2)

Moving Well

EXPERIMENTAL

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.

Behavioral: Moving Well

Staying Well

ACTIVE COMPARATOR

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.

Behavioral: Staying Well

Interventions

Staying Well BEHAVIORAL

Active comparator arm

Staying Well

Moving Well BEHAVIORAL

Experimental arm

Moving Well

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Rheumatology Research Foundation: collaborator
• Hospital for Special Surgery, New York: collaborator

Study Sites (1)

Weill Cornell Medicine Clinical & Translational Science Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Jabri A, Dominguez Paez Y, Brown M, Lui G, Hui WK, Hernandez N, Parks ML, Gonzalez Della Valle A, Goodman SM, Banerjee S, Safford MM, Navarro-Millan I. A single-center, open-label, randomized, parallel-group trial to pilot the effectiveness of a peer coach behavioral intervention versus an active control in reducing anxiety and depression in patients scheduled for total knee replacement. BMC Musculoskelet Disord. 2023 May 5;24(1):353. doi: 10.1186/s12891-023-06460-4.

  PMID: 37147587 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Iris Y Navarro Millan, MD, MSPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only research team members who will collect objective in-person data will be masked
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 1, 2022
• Study Start: April 5, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)