Osteoarthritis, Knee, Osteoarthritis, Hip, Overweight, Obesity, Physical Inactivity, Weight Loss
Conditions
Brief 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 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.
Interventions
BEHAVIORALOA CARE Intervention
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.
BEHAVIORALUsual Care control group
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.
Sponsors
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | Baseline, Month 6 (Follow-up) | 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. |
| Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | Baseline, Month 12 (Follow-up) | 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. |
| Change From Baseline to Month 6 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed. | Baseline, Month 6 (Follow-up) | 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. |
| Change From Baseline to Month 12 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed | Baseline, Month 12 (Follow-up) | 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. |
| Change From Baseline to Month 6 in Steps Per Day, Log Transformed | Baseline, Month 6 (Follow-up) | Step counts measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models. |
| Change From Baseline to Month 12 in Steps Per Day, Log Transformed | Baseline, Month 12 (Follow-up) | Step counts measured via accelerometer. This measure was log transformed because raw data did not meet assumptoms for statsitical models. |
| Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) Per Day, Standardized to a 16 Hour Day | Baseline, Month 6 (Follow-up) | 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. |
| Change From Baseline to Month 12 in Minutes of Any Physical Activity (PA) Per Day, Standardized to 16 Hour Day | Baseline, Month 12 (Follow-up) | 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. |
| Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | Baseline, Month 6 (Follow-up) | 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. |
| Change From Baseline to Month 12 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed | Baseline, Month 12 (Follow-up) | 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. |
| Change From Baseline to Month 6 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day | Baseline, Month 6 (Follow-up) | Sedentary minutes measured via accelerometer This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time. |
| Change From Baseline to Month 12 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day | Baseline, Month 12 (Follow-up) | Sedentary minutes measured via accelerometer This measure was standardized to a 16 hour day to address between-patient differences in amount of wear time. |
| Change From Baseline to Month 12 in Body Weight | Baseline, Month 12 (Follow-up) | Body weight assessed using a research / clinical grade scale (e.g., Tanita) that will be calibrated regularly. |
| Change From Baseline to Month 12 in 30-second Chair Stand Test | Baseline, Month 12 (Follow-up) | 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. |
| Change From Baseline to Month 12 in Timed Up-and-go (TUG) Test | Baseline, Month 12 (Follow-up) | 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. |
| Change From Baseline to Month 12 in 2-minute March Test | Baseline, Month 12 (Follow-up) | Assessed to evaluate participant functional aerobic endurance. Measured by number of steps completed in 2 minutes. |
| Change From Baseline to Month 6 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed | Baseline, Month 6 (Follow-up) | 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. |
| Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | Baseline, Month 12 (Follow-up) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OA CARE 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.
OA CARE Intervention: 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. | 30 |
| Usual Care Participants assigned to this group will receive no additional treatment from the study for about 12 months.
Usual Care control group: 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Usual Care | Total | OA CARE |
|---|---|---|---|
| Age, Continuous | 65.6 years STANDARD_DEVIATION 9.1 | 64.4 years STANDARD_DEVIATION 9.8 | 63.2 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 58 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 21 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 37 Participants | 17 Participants |
| Sex: Female, Male Female | 25 Participants | 49 Participants | 24 Participants |
| Sex: Female, Male Male | 5 Participants | 11 Participants | 6 Participants |
| WOMAC Total Score | 37.9 units on a scale STANDARD_DEVIATION 17.3 | 39.3 units on a scale STANDARD_DEVIATION 15.8 | 40.7 units on a scale STANDARD_DEVIATION 14.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: Baseline, Month 12 (Follow-up)
Population: Participants who completed both baseline and 12-month follow-up assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score | -8.3 units on a scale |
| Usual Care | Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score | -3.3 units on a scale |
p-value: 0.28695% CI: [-14.1, 4.3]Mixed Models Analysis
Primary
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.
Time frame: Baseline, Month 6 (Follow-up)
Population: Participants who completed both baseline and 6-month follow-up assessments
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score | -7.8 units on a scale |
| Usual Care | Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score | 3.2 units on a scale |
p-value: 0.01995% CI: [-20.1, -1.9]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 12 (Follow-up)
Population: Participants who completed both baseline and 12-month follow-up 2-minute march tests.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 12 in 2-minute March Test | 29.7 steps |
| Usual Care | Change From Baseline to Month 12 in 2-minute March Test | 14.8 steps |
p-value: 0.06695% CI: [-1, 30.8]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 12 (Follow-up)
Population: Participants who completed both baseline and 12-month follow-up chair stand tests.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 12 in 30-second Chair Stand Test | -0.9 number of chair stands in 30 seconds |
| Usual Care | Change From Baseline to Month 12 in 30-second Chair Stand Test | -0.6 number of chair stands in 30 seconds |
p-value: 0.70995% CI: [-2.5, 1.7]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 12 (Follow-up)
Population: Participants who completed both baseline and 12-month follow-up weight assessment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 12 in Body Weight | -7.6 kg |
| Usual Care | Change From Baseline to Month 12 in Body Weight | -5.4 kg |
p-value: 0.68895% CI: [-13.4, 8.9]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 12 (Follow-up)
Population: Participants who completed both baseline and 12-month follow-up acceleromter assessments. Note that some participants completed questionnaires but not accelerometer wear.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 12 in Minutes of Any Physical Activity (PA) Per Day, Standardized to 16 Hour Day | -0.1 min/day |
| Usual Care | Change From Baseline to Month 12 in Minutes of Any Physical Activity (PA) Per Day, Standardized to 16 Hour Day | -0.1 min/day |
p-value: 0.64895% CI: [-0.2, 0.1]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 12 (Follow-up)
Population: Participants who completed baseline and 6-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 12 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed | -0.3 log (minutes / week) |
| Usual Care | Change From Baseline to Month 12 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed | -0.1 log (minutes / week) |
p-value: 0.30395% CI: [-0.6, 0.2]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 12 (Follow-up)
Population: Participants who completed baseline and 12-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 12 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day | 18.6 minutes / day |
| Usual Care | Change From Baseline to Month 12 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day | 9.3 minutes / day |
p-value: 0.63895% CI: [-30.6, 49.2]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 12 (Follow-up)
Population: Participants who completed baseline and 12-month questionnaires
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 12 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed | 4.3 square root (minutes per week) |
| Usual Care | Change From Baseline to Month 12 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed | 2.2 square root (minutes per week) |
p-value: 0.31595% CI: [-2.1, 6.3]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 12 (Follow-up)
Population: Participants who completed baseline and 12-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 12 in Steps Per Day, Log Transformed | -0.1 log (steps / day) |
| Usual Care | Change From Baseline to Month 12 in Steps Per Day, Log Transformed | -0.1 log (steps / day) |
p-value: 0.72995% CI: [-0.2, 0.2]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 12 (Follow-up)
Population: Participants who completed both baseline and 12-month TUG tests.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 12 in Timed Up-and-go (TUG) Test | 0.5 seconds |
| Usual Care | Change From Baseline to Month 12 in Timed Up-and-go (TUG) Test | 2.0 seconds |
p-value: 0.08995% CI: [-3.3, 0.2]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 12 (Follow-up)
Population: Participants who completed baseline and 12-month follow-up assessments
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | -4.5 units on a scale |
| Usual Care | Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | -2.6 units on a scale |
p-value: 0.56495% CI: [-8.8, 4.9]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 12 (Follow-up)
Population: Participants who completed baseline and 12-month follow-up assessments
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | -2.1 units on a scale |
| Usual Care | Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | -0.4 units on a scale |
p-value: 0.12895% CI: [-3.8, 0.5]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 6 (Follow-up)
Population: Participants who completed both baseline and 6-month follow-up acceleromter assessments. Note that some participants completed questionnaires but not accelerometer wear.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) Per Day, Standardized to a 16 Hour Day | -0.0 minutes / day |
| Usual Care | Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) Per Day, Standardized to a 16 Hour Day | 0.0 minutes / day |
p-value: 0.42195% CI: [-0.2, 0.1]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 6 (Follow-up)
Population: Participants who completed baseline and 6-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 6 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed. | 0.2 log (minutes / week) |
| Usual Care | Change From Baseline to Month 6 in Objectively Assessed Physical Activity Per Week (Accelerometer), Log Transformed. | -0.0 log (minutes / week) |
p-value: 0.34995% CI: [-0.2, 0.6]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 6 (Follow-up)
Population: Participants who completed baseline and 6-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 6 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day | 10.5 minutes / day |
| Usual Care | Change From Baseline to Month 6 in Sedentary Minutes Per Day, Standardized to a 16 Hour Day | -2.9 minutes / day |
p-value: 0.44495% CI: [-21.5, 48.2]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 6 (Follow-up)
Population: Participants who completed baseline and 6-month questionnaires
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 6 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed | 4.6 square root (minutes per week) |
| Usual Care | Change From Baseline to Month 6 in Self-Reported Minutes of Moderate to Vigorous Physical Activity Per Week, Square Root Transformed | 1.2 square root (minutes per week) |
p-value: 0.03495% CI: [0.3, 6.5]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 6 (Follow-up)
Population: Participants who completed baseline and 6-month accelerometer assessments. Note that some participants completed follow-up questionnaires but not accelerometer wear.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 6 in Steps Per Day, Log Transformed | 0.00 log (steps / day) |
| Usual Care | Change From Baseline to Month 6 in Steps Per Day, Log Transformed | -0.0 log (steps / day) |
p-value: 0.50795% CI: [-0.1, 0.2]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 6 (Follow-up)
Population: Participants who completed baseline and 6-month follow-up assessments
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | -4.9 units on a scale |
| Usual Care | Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | 2.6 units on a scale |
p-value: 0.03195% CI: [-14.3, -0.7]Mixed Models Analysis
Secondary
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.
Time frame: Baseline, Month 6 (Follow-up)
Population: Participants who completed baseline and 6-month follow-up assessments
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA CARE | Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | -1.5 units on a scale |
| Usual Care | Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | 0.5 units on a scale |
p-value: 0.04695% CI: [-4, 0]Mixed Models Analysis