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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
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
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 moreTrial 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.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,077 Previous Clinical Trials
1,320,567 Total Patients Enrolled
Rheumatology Research FoundationOTHER
11 Previous Clinical Trials
7,963 Total Patients Enrolled
1 Trials studying Osteoarthritis
40 Patients Enrolled for Osteoarthritis
Hospital for Special Surgery, New YorkOTHER
249 Previous Clinical Trials
61,229 Total Patients Enrolled
26 Trials studying Osteoarthritis
4,295 Patients Enrolled for Osteoarthritis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to travel to New York City (Upper East Side) for in-person data collection visits.You either have severe anxiety (score of 10 or higher on GAD-7) or depression (score of 10 or higher on PHQ-8).You have certain types of arthritis or connective tissue diseases like lupus, ankylosing spondylitis, psoriatic arthritis, scleroderma, infectious arthritis, or polymyalgia rheumatica.You have a primary (first) total knee replacement scheduled in 8 weeks or more.You had a knee replacement surgery because of a severe infection or an issue with the implant.
Research Study Groups:
This trial has the following groups:- Group 1: Moving Well
- Group 2: Staying Well
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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