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OA CARE Intervention for Osteoarthritis (OA CARE Trial)
N/A
Waitlist Available
Led By Kelli D Allen, PhD
Research Sponsored by University of North Carolina, Chapel Hill
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 baseline, month 12 (follow-up)
Awards & highlights
OA CARE Trial Summary
This trial will test whether the OA Clinic-Community CARE Model is an effective way to address all recommended components of knee/hip (osteoarthritis) care, including interventions for both patients and primary care providers (PCPs).
Who is the study for?
This trial is for adults with knee or hip pain from osteoarthritis, who exercise less than 150 minutes a week and have a BMI of at least 27. It's not for those with recent severe injuries, surgeries, certain heart conditions, dementia, severe sensory impairments, lack of internet access or other health issues that make exercise or weight loss unsafe.Check my eligibility
What is being tested?
The OA CARE Model is being tested to see if it helps people with osteoarthritis by providing tailored weight management and exercise programs through the YMCA. It also includes education for primary care providers on OA treatment guidelines and tracks patient progress.See study design
What are the potential side effects?
Since this intervention involves lifestyle changes like diet and exercise rather than medication, side effects may include typical exercise-related discomforts such as muscle soreness or strain but are generally minimal compared to drug treatments.
OA CARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 12 (follow-up)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 12 (follow-up)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
Secondary outcome measures
Change From Baseline to Month 12 in 2-minute march test
Change From Baseline to Month 12 in 30-second chair stand test
Change From Baseline to Month 12 in Body Weight
+15 moreOA CARE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OA CAREExperimental Treatment1 Intervention
Participants assigned to the OA CARE intervention will receive a 12-month Medical Membership to a local YMCA and participate in a 12-week weight loss program. Participants will also work with an OA CARE Navigator, who, in partnership with their primary care provider (PCP), will identify any additional programs or resources that may help them manage their osteoarthritis (OA) symptoms.
Group II: Usual CarePlacebo Group1 Intervention
Participants assigned to this group will receive no additional treatment from the study for about 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OA CARE Intervention
2022
N/A
~60
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a body mass index (BMI) of 27 or higher.You have a condition that affects your memory, such as dementia.You have fallen three or more times in the past 6 months.You experience knee or hip pain that is equal to or greater than 3 on a scale of 0 to 10, most days of the week.You are not currently engaging in at least 150 minutes of physical activity each week.You experience chest pain during physical activity.You had a major injury or surgery in your hip, knee or leg within the last 6 months.You have a significant hearing or vision loss.You have had a stroke that has caused significant difficulty in speaking or understanding language.Your doctor has diagnosed you with knee or hip osteoarthritis.You currently have a mental illness called psychosis that is being treated.You have a current addiction to drugs or alcohol.The study team has determined that your health condition makes it unsafe for you to participate in a home exercise program or weight loss program.You experience chest pain while at rest.You have a severe or life-threatening illness and have been referred to hospice or palliative care.You are currently involved in another study related to knee or hip osteoarthritis, or physical activity.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: OA CARE
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total number of participants in this experimental treatment?
"Affirmative. According to clinicaltrials.gov, the medical study is open for recruitment as of June 7th 2022 and was last modified on June 8th 2022. There are 60 vacancies across 1 site that need to be filled."
Answered by AI
Could I potentially enter into this research endeavor?
"Those wishing to participate must have been diagnosed with knee osteoarthritis and between the ages of 18-99. The medical study requires 60 participants in total."
Answered by AI
What are the goals of this experiment?
"The purpose of this clinical trial that will be assessed over a Baseline and Month 12 (Follow-up) period is to observe the Change From Baseline To Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score. Secondary observations include Step counts per day, WOMAC's Pain Subscale between 0 (no pain) to 4(extreme pain), as well as Objectively Assessed Physical Activity (accelerometer)."
Answered by AI
Is there an age cap for participants of this research?
"This clinical trial is accepting participants between 18 and 99 years of age."
Answered by AI
Are there remaining vacancies in this trial for eligible participants?
"Affirmative. Information from clinicaltrials.gov signals that this investigation is actively searching for participants, with the first posting of June 7th 2022 and the most recent update on June 8th 2022. The trial requires 60 volunteers to be gathered at 1 medical centre."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
South Carolina
What site did they apply to?
UNC Thurston Arthritis Research Center
What portion of applicants met pre-screening criteria?
Met criteria
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