Osteoarthritis
Conditions
Keywords
Osteoarthritis, Knee Osteoarthritis, Hip Osteoarthritis
Brief summary
The purpose of this study is to test an osteoarthritis (OA) primary care Physical activity Care Pathway (OA-PCP), a scalable intervention that includes: 1) a practical process for physical inactivity screening in primary care, 2) a brief, tailored physical activity (PA) counseling intervention via telephone, 3) connection of patients with community programs and other resources to support PA, and 4) follow-up with patients to deliver additional appropriate counseling and referrals to PA resources. This program will be compared to another program that provides education on a variety of topics important to understanding osteoarthritis (OA) and its care.
Detailed description
This study will be a randomized pilot trial of the refined OA-PCP among n=240 patients age ≥65 with hip and/or knee OA recruited from primary care clinics. Participants will be assigned equally to either the OA-PCP or an attention control group. Participants will complete assessments at baseline, and 6-month and 12-month follow-up. Primary endpoint of the trial will be objectively assessed PA, measured via accelerometer and secondary endpoint will be self-reported pain and function.
Interventions
BEHAVIORALOA-PCP Intervention
The OA-PCP intervention includes brief physical activity (PA) counseling delivered via phone by a PA Coach trained in relevant aspects of PA and motivational interviewing. During the initial call, the PA Coach will ask participants about their current physical activity level and work with them to set physical activity goals. Then, after the first call, participants in this group will receive a call about two weeks later, then at about 3 months, 6 months, 9 months and 12 months later. During these calls, the PA coach will ask participants' about their progress toward PA goals and work with them to address any barriers or challenges. The coach will also help participants to identify any programs or resources that may help them to achieve their PA goals. Participants in this group will be asked to wear a wrist-worn monitor to help them track their PA during the intervention period. Also, if participants approve, the coach will use an online program to view their PA data.
BEHAVIORALAttention Control
This group will receive an intervention in the same dose (e.g., number and duration of phone calls and emails) as the OA-PCP group, but the content will not be PA-specific. During the first call, the Coach will discuss 2 topics, for which the amount of content parallels call #1 for the OA-PCP: What is OA? OA Diagnosis and OA Risk Factors. During the second call, the Coach will discuss the topic of Health Care Providers and Overview of OA Treatment Guidelines. Call topics for 3, 6, 9 and 12- month follow-up calls will be: Pain Medications, Mechanical Treatments (e.g., knee braces, footwear, joint protection), Complimentary and Alternative Therapies and discussion of OA and Mental Health, Sleep and Fatigue.
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
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
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 65 or older * One other chronic health condition that qualified under Chronic Care Management (CCM) guidelines, including: diabetes, depression, hypertension, hyperlipidemia, heart failure, atrial fibrillation, ischemic heart disease, stroke/transient ischemic attack (TIA), peripheral vascular disease, Chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, rheumatoid arthritis, osteoarthritis, HIV/AIDS, chronic kidney disease, hepatitis (chronic & viral B & C) and osteoporosis * Current Joint Symptoms * Self-reported physical activity \<150 minutes per week * Willing to make a change in PA over the next 3 months
Exclusion criteria
* Pain in chest when performing physical activity * Pain in chest when not performing physical activity * Loss of balance because of dizziness or loss of consciousness * Recommendation from doctor to only perform physical activity under medical supervision * No documented diagnosis of knee or hip OA * Dementia or other memory loss condition * Active diagnosis of psychosis * Active Substance abuse disorder * Total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months * Severe hearing or visual impairment * Serious/terminal illness as indicated by referral to hospice or palliative care * Unstable angina * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer) | Baseline, Month 6 (Follow-up) | Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer |
| Change From Baseline to Month 12 for Minutes in Objectively Assessed Physical Activity (Accelerometer) | Baseline, Month 12 (Follow-up) | Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Month 6 for Minutes of Sedentary Activity | Baseline, Month 6 (Follow-up) | Minutes of sedentary activity measured via an accelerometer device. |
| Change From Baseline to Month 12 for Minutes of Sedentary Activity | Baseline, Month 12 (Follow-up) | Minutes of sedentary activity measured via an accelerometer device. |
| Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | Baseline, Month 6 (Follow-up) | The Western Ontario and McMasters Universities Osteoarthritis (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 for Steps Per Day | Baseline, Month 6 (Follow-up) | Step counts measured via an accelerometer device. |
| Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | Baseline, Month 6 (Follow-up) | The Western Ontario and McMasters Universities Osteoarthritis (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 Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | Baseline, Month 12 (Follow-up) | The Western Ontario and McMasters Universities Osteoarthritis (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 Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | Baseline, Month 12 (Follow-up) | The Western Ontario and McMasters Universities Osteoarthritis (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 for Steps Per Day | Baseline, Month 12 (Follow-up) | Step counts measured via an accelerometer device. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OA-PCP Participants assigned to the OA-PCP intervention will receive an initial physical activity (PA) coaching call then, 5 more calls over the course of 12 months. Participants, if they agree, will also receive monthly check-in emails between phone calls.
OA-PCP Intervention: The OA-PCP intervention includes brief physical activity (PA) counseling delivered via phone by a PA Coach trained in relevant aspects of PA and motivational interviewing. During the initial call, the PA Coach will ask participants about their current physical activity level and work with them to set physical activity goals. Then, after the first call, participants in this group will receive a call about two weeks later, then at about 3 months, 6 months, 9 months and 12 months later. During these calls, the PA coach will ask participants' about their progress toward PA goals and work with them to address any barriers or challenges. The coach will also help participants to identify any programs or resources that may help them to achieve their PA goals. Participants in this group will be asked to wear a wrist-worn monitor to help them track their PA during the intervention period. Also, if participants approve, the coach will use an online program to view their PA data. | 120 |
| Attention Control Participants assigned to the Attention Control group will receive the same number of phone calls over the course of 12 months, focused on understanding osteoarthritis (OA) and current information on treatment options. Participants, if they agree, will also receive monthly check-in emails between phone calls.
Attention Control: This group will receive an intervention in the same dose (e.g., number and duration of phone calls and emails) as the OA-PCP group, but the content will not be PA-specific. During the first call, the Coach will discuss 2 topics, for which the amount of content parallels call #1 for the OA-PCP: What is OA? OA Diagnosis and OA Risk Factors. During the second call, the Coach will discuss the topic of Health Care Providers and Overview of OA Treatment Guidelines. Call topics for 3, 6, 9 and 12- month follow-up calls will be: Pain Medications, Mechanical Treatments (e.g., knee braces, footwear, joint protection), Complimentary and Alternative Therapies and discussion of OA and Mental Health, Sleep and Fatigue. | 120 |
| Total | 240 |
Baseline characteristics
| Characteristic | OA-PCP | Total | Attention Control |
|---|---|---|---|
| Age, Continuous | 72.88 Years STANDARD_DEVIATION 4.79 | 73.22 Years STANDARD_DEVIATION 4.83 | 73.56 Years STANDARD_DEVIATION 4.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants | 232 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 8 Participants | 5 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 | 36 Participants | 74 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 82 Participants | 159 Participants | 77 Participants |
| Region of Enrollment United States | 120 Participants | 240 Participants | 120 Participants |
| Sex: Female, Male Female | 101 Participants | 199 Participants | 98 Participants |
| Sex: Female, Male Male | 19 Participants | 41 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 120 | 0 / 120 |
| other Total, other adverse events | 1 / 120 | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 | 0 / 120 |
Outcome results
Primary
Change From Baseline to Month 12 for Minutes in Objectively Assessed Physical Activity (Accelerometer)
Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer
Time frame: Baseline, Month 12 (Follow-up)
Population: 58 participants did not complete 12-month follow-up assessments, and 26 did not have adequate physical activity data for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 12 for Minutes in Objectively Assessed Physical Activity (Accelerometer) | 1.72 Minutes per week |
| Attention Control | Change From Baseline to Month 12 for Minutes in Objectively Assessed Physical Activity (Accelerometer) | -9.21 Minutes per week |
p-value: 0.18295% CI: [-5.06, 26.92]Mixed Models Analysis
Primary
Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)
Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer
Time frame: Baseline, Month 6 (Follow-up)
Population: 46 participants did not complete 6-month follow-up assessments, and 30 did not have adequate physical activity data for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer) | -2.40 Minutes per week |
| Attention Control | Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer) | -10.8 Minutes per week |
p-value: 0.308695% CI: [-7.68, 24.38]Mixed Models Analysis
Secondary
Change From Baseline to Month 12 for Minutes of Sedentary Activity
Minutes of sedentary activity measured via an accelerometer device.
Time frame: Baseline, Month 12 (Follow-up)
Population: 58 participants did not complete 12-month follow-up assessments, and 26 did not have adequate physical activity data for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 12 for Minutes of Sedentary Activity | 8.05 minutes per day |
| Attention Control | Change From Baseline to Month 12 for Minutes of Sedentary Activity | 10.30 minutes per day |
p-value: 0.804195% CI: [-20, 15.49]Mixed Models Analysis
Secondary
Change From Baseline to Month 12 for Steps Per Day
Step counts measured via an accelerometer device.
Time frame: Baseline, Month 12 (Follow-up)
Population: 58 participants did not complete 12-month follow-up assessments, and 26 did not have adequate physical activity data for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 12 for Steps Per Day | -80.9 steps per day |
| Attention Control | Change From Baseline to Month 12 for Steps Per Day | -433 steps per day |
p-value: 0.069195% CI: [-25.2, 729.2]Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
The Western Ontario and McMasters Universities Osteoarthritis (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: 58 participants did not complete 12-month follow-up assessments, and 4 did not have adequate data for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | -2.95 score on a scale |
| Attention Control | Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | -0.27 score on a scale |
p-value: 0.098995% CI: [-5.85, 0.49]Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
The Western Ontario and McMasters Universities Osteoarthritis (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: 58 participants did not complete 12-month follow-up assessments.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | -1.39 score on a scale |
| Attention Control | Change From Baseline to Month 12 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | -0.52 score on a scale |
p-value: 0.089495% CI: [-1.87, 0.13]Mixed Models Analysis
Secondary
Change From Baseline to Month 6 for Minutes of Sedentary Activity
Minutes of sedentary activity measured via an accelerometer device.
Time frame: Baseline, Month 6 (Follow-up)
Population: 46 participants did not complete 6-month follow-up assessments, and 30 did not have adequate physical activity data for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 6 for Minutes of Sedentary Activity | 0.26 minutes per day |
| Attention Control | Change From Baseline to Month 6 for Minutes of Sedentary Activity | 6.11 minutes per day |
p-value: 0.495395% CI: [-22.6, 10.94]Mixed Models Analysis
Secondary
Change From Baseline to Month 6 for Steps Per Day
Step counts measured via an accelerometer device.
Time frame: Baseline, Month 6 (Follow-up)
Population: 46 participants did not complete 6-month follow-up assessments, and 30 did not have adequate physical activity data for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 6 for Steps Per Day | -1.00 steps per day |
| Attention Control | Change From Baseline to Month 6 for Steps Per Day | -309 steps per day |
p-value: 0.09495% CI: [-50.2, 667.1]Mixed Models Analysis
Secondary
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
The Western Ontario and McMasters Universities Osteoarthritis (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: 46 participants did not complete 6-month follow-up assessments, and 2 did not have adequate data for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | -1.06 score on a scale |
| Attention Control | Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | -1.12 score on a scale |
p-value: 0.964595% CI: [-2.86, 2.99]Mixed Models Analysis
Secondary
Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
The Western Ontario and McMasters Universities Osteoarthritis (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: 46 participants did not complete 6-month follow-up assessments.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | -0.56 score on a scale |
| Attention Control | Change From Baseline to Month 6 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | -0.70 score on a scale |
p-value: 0.766795% CI: [-0.77, 1.05]Mixed Models Analysis