Osteoarthritis, KneeOA CARENCT05349500
OA Clinic-Community CARE Model
A study testing OA CARE Intervention in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to test the OA Clinic-Community CARE Model (OA CARE) which will address all recommended components of knee/hip (osteoarthritis) OA care, include interventions for both patients and primary care providers (PCPs), and utilize a tailored approach that efficiently matches treatments with… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip, Overweight
- What is being tested?
- OA CARE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 8 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinician diagnosis of knee or hip OA
- Self-reported knee or hip pain of ≥3 (scale of 0-10) on most days of the week
- Current Weekly Physical Activity <150 minutes per week
- Body mass index (BMI) ≥27 kg/m^2
Who cannot join
- No internet access and a device (computer, tablet, smartphone) to access the virtual weight loss intervention
- Pain in chest when performing physical activity
- Pain in chest when not performing physical activity
- No documented diagnosis of knee or hip OA
- Total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months
- Dementia or other memory loss condition
Show all 19Show fewer
- Active diagnosis of psychosis
- Active Substance abuse disorder
- Severe hearing or visual impairment
- Serious/terminal illness as indicated by referral to hospice or palliative care
- Hospitalization for cardiovascular event in last 6 months
- History of ventricular tachycardia
- Unstable chronic obstructive pulmonary disease (2 hospitalizations within the previous 6 months and/or on oxygen)
- Stroke with moderate to severe aphasia
- Recent history (last 6 months) of three or more falls
- Planning total joint replacement in next 6 months
- Any other health conditions determined by the study team to be contraindications to a home exercise program or weight loss
- Current participation in other study related to knee or hip osteoarthritis or physical activity
- Unable to speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Thurston Arthritis Research Center
Chapel Hill, North Carolina, 27599
About this study
Official title: Optimizing Osteoarthritis Care Through Clinical and Community Partnership
The purpose of this study is to test the OA Clinic-Community CARE Model (OA CARE) which will address all recommended components of knee/hip (osteoarthritis) OA care, include interventions for both patients and primary care providers (PCPs), and utilize a tailored approach that efficiently matches treatments with patients' needs.
The patient component of OA CARE will include evidence-based weight management and exercise programs for all participants (delivered through the YMCA), as well as tailored referrals to physical therapy, additional weight management or nutrition services, sleep-related services and psychological services.
The PCP component of OA CARE will include a video-based summary of current OA treatment guidelines (with emphasis on practical application), collaboration on patients' referrals to specific services described above, and progress reports on enrolled patients.
Read the detailed description
This study will be a randomized pilot trial of OA CARE among n=60 patients with knee and/or hip osteoarthritis (OA) and overweight/obesity who are not currently meeting physical activity recommendations. Participants will be randomly assigned to OA CARE or a usual care (UC) group. Assessments will be conducted at baseline, 6 months and 12 months. Primary endpoint of the trial will be self-reported pain and function and secondary endpoint will be objectively assessed physical activity (PA), measured via accelerometer.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Overweight, Obesity, Physical Inactivity, Weight Loss
- Being tested
- OA CARE Intervention, Usual Care control group
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Overweight, Obesity, Sedentary Behavior, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OA CARE InterventionBehavioural
Once assigned, participants will be contacted by the OA CARE Navigator to coordinate initiating a YMCA Medical Membership. Then, YMCA personnel will contact the participant to schedule the first Weight Loss Program (Program) group session. The Program will be delivered in groups with other OA CARE participants. Participants will also have access to all exercise facilities and programs at the YMCA during the study, and will be assigned a YMCA health coach.
After initiation of the YMCA Medical Membership, the OA CARE Navigator will discuss participant's interests in referrals to other services related to osteoarthritis (OA) management. The Navigator will provide the participant's primary care provider (PCP) with a summary of this discussion and help the participant connect to any programs or resources that do not require provider referrals.
Usual Care control groupBehavioural
Participants assigned to the usual care group will receive no additional treatment from the study for about 12 months. However, this group will be offered a 12-month Medical Membership to a local YMCA after completing the final assessment.
| Study group | Role | What they receive |
|---|---|---|
| OA CARE | Experimental | 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. Receives: Behavioral: OA CARE Intervention |
| Usual Care | Placebo comparator | Participants assigned to this group will receive no additional treatment from the study for about 12 months. Receives: Behavioral: Usual Care control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations.
Measured: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations.
Measured: Baseline, Month 12 (Follow-up)
Secondary outcomes (18)
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
The WOMAC Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function.
Measured: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
The WOMAC Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no pain) to 4 (extreme pain), with a total range of 0-20 with higher scores indicating worse symptoms and function.
Measured: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
The WOMAC function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function.
Measured: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
The WOMAC function subscale includes 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty), with ranges of 0-68 for the function subscale with higher scores indicating worse symptoms and function.
Measured: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 6 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed.
Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer.
This measure was log transformed because raw data did not meet assumptoms for statsitical models.
Measured: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed
Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer.
This measure was log transformed because raw data did not meet assumptoms for statsitical models.
Measured: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 6 in Steps Per Day, Log Transformed
Step counts measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models.
Measured: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Steps Per Day, Log Transformed
Step counts measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models.
Measured: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) Per Day, Standardized to a 16 Hour Day
Minutes of any PA measured via accelerometer. This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time.
Measured: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Minutes of Any Physical Activity (PA) Per Day, Standardized to 16 Hour Day
Minutes of any PA measured via accelerometer. This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time.
Measured: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 6 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed
Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents MET ≥ 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity. This measure was square root transformed becuase raw failed to meet assumptions for statistical analyses.
Measured: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed
Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. Separate scores are derived for physical activities of moderate or greater intensity (metabolic equivalents (MET) ≥ 3.0) and for all activities listed (light, moderate, and vigorous). Estimates of frequency (days per week) range from 0 to 7 days per week. Estimates of Variety (# different activities), while open, generally ranges from 0 to 5, values above 5 are checked. Estimates of minutes, generally range from 0 to 180 per day. Individuals reporting more than 180 minutes per day are checked. For all physical activity outcomes higher values equal a greater amount of activity.
This measure was square root transformed because raw data did not meet assumptions for statistical models.
Measured: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 6 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day
Sedentary minutes measured via accelerometer This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time.
Measured: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day
Sedentary minutes measured via accelerometer This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time.
Measured: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 12 in Body Weight
Body weight assessed using a research / clinical grade scale (e.g., Tanita) that will be calibrated regularly.
Measured: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 12 in 30-second Chair Stand Test
Assessed to test participant leg strength and endurance. Measured by total number of chair stands (up and down equals one stand) completed in 30 seconds.
Measured: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 12 in Timed Up-and-go (TUG) Test
Assessed to measure participant functional mobility. Measured by how many seconds it takes for participant to stand up, walk to the mark, turn around, return \& sit back into a chair with their back resting on the back of the chair.
Measured: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 12 in 2-minute March Test
Assessed to evaluate participant functional aerobic endurance. Measured by number of steps completed in 2 minutes.
Measured: Baseline, Month 12 (Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start7 Jun 2022
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Kelli D Allen, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349500
- Sponsor's protocol ID
- 22-0865
- Other IDs
- 1R21AR080309-01
- Acronym
- OA CARE
- Status last verified
- Jan 2023
- First submitted
- 21 Apr 2022
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/ sharing agreement with University of North Carolina at Chapel Hill (UNC).
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Osteoarthritis Care Through Clinical and Community Partnership
- ClinicalTrials.gov ID
- NCT05349500
- Acronym / sponsor ID
- OA CARE / 22-0865
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Overweight, Obesity, Physical Inactivity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the OA Clinic-Community CARE Model (OA CARE) which will address all recommended components of knee/hip (osteoarthritis) OA care, include interventions for both patients and primary care providers (PCPs), and utilize a tailored approach that efficiently matches treatments with patients' needs.
The patient component of OA CARE will include evidence-based weight management and exercise programs for all participants (delivered through the YMCA), as well as tailored referrals to physical therapy, additional weight management or nutrition services, sleep-related services and psychological services.
The PCP component of OA CARE will include a video-based summary of current OA treatment guidelines (with emphasis on practical application), collaboration on patients' referrals to specific services described above, and progress reports on enrolled patients.
Detailed description
This study will be a randomized pilot trial of OA CARE among n=60 patients with knee and/or hip osteoarthritis (OA) and overweight/obesity who are not currently meeting physical activity recommendations. Participants will be randomly assigned to OA CARE or a usual care (UC) group. Assessments will be conducted at baseline, 6 months and 12 months. Primary endpoint of the trial will be self-reported pain and function and secondary endpoint will be objectively assessed physical activity (PA), measured via accelerometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OA CARE | Experimental | Behavioral: OA CARE InterventionParticipants 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. |
| Usual Care | Placebo comparator | Behavioral: Usual Care control groupParticipants assigned to this group will receive no additional treatment from the study for about 12 months. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinician diagnosis of knee or hip OA
- Self-reported knee or hip pain of ≥3 (scale of 0-10) on most days of the week
- Current Weekly Physical Activity <150 minutes per week
- Body mass index (BMI) ≥27 kg/m^2
Key exclusion criteria (19 listed)
- No internet access and a device (computer, tablet, smartphone) to access the virtual weight loss intervention
- Pain in chest when performing physical activity
- Pain in chest when not performing physical activity
- No documented diagnosis of knee or hip OA
- Total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OA CARE InterventionOnce assigned, participants will be contacted by the OA CARE Navigator to coordinate initiating a YMCA Medical Membership. Then, YMCA personnel will contact the participant to schedule the first Weight Loss Program (Program) group session. The Program will be delivered in groups with other OA CARE participants. Participants will also have access to all exercise facilities and programs at the YMCA during the study, and will be assigned a YMCA health coach. After initiation of the YMCA Medical Membership, the OA CARE Navigator will discuss participant's interests in referrals to other services related to osteoarthritis (OA) management. The Navigator will provide the participant's primary care provider (PCP) with a summary of this discussion and help the participant connect to any programs or resources that do not require provider referrals. | Behavioural | OA CARE |
| Usual Care control groupParticipants assigned to the usual care group will receive no additional treatment from the study for about 12 months. However, this group will be offered a 12-month Medical Membership to a local YMCA after completing the final assessment. | Behavioural | Usual Care |
Primary outcome
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
Time frame: Baseline, Month 6 (Follow-up)
For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations.
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
Time frame: Baseline, Month 12 (Follow-up)
For the WOMAC total score, the test questions are scored on a scale of 0-4. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The overall WOMAC score is determined by summing the scores for all three subscales and the score ranges include 0-96 (derived from a 0-4 Likert scale), with higher scores indicating worse pain, stiffness, and functional limitations.
18 secondary outcomes
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
Time frame: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
Time frame: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
Time frame: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
Time frame: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 6 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed.
Time frame: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed
Time frame: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 6 in Steps Per Day, Log Transformed
Time frame: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Steps Per Day, Log Transformed
Time frame: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) Per Day, Standardized to a 16 Hour Day
Time frame: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Minutes of Any Physical Activity (PA) Per Day, Standardized to 16 Hour Day
Time frame: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 6 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed
Time frame: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed
Time frame: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 6 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day
Time frame: Baseline, Month 6 (Follow-up)
Change From Baseline to Month 12 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day
Time frame: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 12 in Body Weight
Time frame: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 12 in 30-second Chair Stand Test
Time frame: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 12 in Timed Up-and-go (TUG) Test
Time frame: Baseline, Month 12 (Follow-up)
Change From Baseline to Month 12 in 2-minute March Test
Time frame: Baseline, Month 12 (Follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/ sharing agreement with University of North Carolina at Chapel Hill (UNC).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelli D Allen, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OA CARE Intervention in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score (time frame: Baseline, Month 6 (Follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.