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Moving Well for Osteoarthritis

N/A

Recruiting

Led By Iris Y Navarro Millan, MD, MSPH

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a behavioral intervention can improve anxiety and depression levels for patients undergoing total knee arthroplasty.

Who is the study for?

This trial is for English-speaking individuals aged 50 or older with high anxiety or depression, who have internet access and can travel to NYC. They must be scheduled for their first knee replacement in at least 8 weeks and willing to work with a coach. Priority goes to those with low socioeconomic status or from underrepresented racial groups.

What is being tested?

The study tests 'Moving Well,' a behavioral intervention aimed at reducing anxiety and depression in patients awaiting knee replacement surgery. Participants will either receive this intervention or join the control group, which involves an alternative program called 'Staying Well.'

What are the potential side effects?

Since this is a behavioral intervention rather than medication, traditional side effects are not expected. However, participants may experience discomfort related to engaging in new activities or stress management techniques.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in level of anxiety from baseline using the Generalized Anxiety Disorder Assessment (GAD-7)

Change in level of depression from baseline using the Patient Health Questionnaire-8 (PHQ-8)

Secondary study objectives

Change in 30-second chair to stand test from baseline

Change in 6-minute walk test (6MWT) from baseline

Change in Timed Up and Go test (TUG) from baseline

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Moving WellExperimental Treatment1 Intervention

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.

Group II: Staying WellActive Control1 Intervention

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.

Do I qualify?Apply below to find out