Osteoarthritis
Conditions
Keywords
Osteoarthritis, Knee Osteoarthritis, Hip Osteoarthritis
Brief summary
This is a multi-phase study that will develop and 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.
Detailed description
This study will be a single group pilot trial of the OA-PCP. The feasibility and acceptability of the OA-PCP will be assessed among n=60 patients with hip and knee OA in two primary care clinics. All patients in the trial will participate in the OA-PCP and will complete assessments at baseline and 4-month follow-up. Feasibility metrics will include rates of recruitment, intervention engagement and retention; acceptability will be assessed from both patients and health care providers.
Interventions
BEHAVIORALOsteoarthritis Physical Activity Care Pathway
The intervention includes brief physical activity (PA) counseling delivered via phone by a PA Counselor trained in relevant aspects of PA and motivational interviewing. During the initial call, the PA counselor will assess readiness for change in PA and will utilize appropriate PA counseling components to assess participant's PA preferences/needs, as well as referral to PA resources and goal setting. Approximately two weeks after the initial call, the PA counselor will contact participants to check in on whether they have successfully connected with PA programs or resources discussed, review progress toward PA goals and set new goals. Participants will be provided with linkage to PA programs and resources to include: self-directed, group classes/community, physical therapy and other clinical/supervised programs. Three months after the initial call, the PA counselor will call participants to assess PA and stage of change using appropriate PA counseling components and goal setting.
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Physician diagnosis of knee or hip OA * Current Joint Symptoms * Current Weekly Physical Activity \<150 minutes per week.
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 4 for Minutes of Moderate to Vigorous Intensity PA Per Week | Baseline, Month 4 (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 4 for Steps Per Day | Baseline, Month 4 (Follow-up) | Step counts were measured via an accelerometer device. |
| Change From Baseline to Month 4 for Minutes of Sedentary Activity | Baseline, Month 4 (Follow-up) | Minutes of sedentary activity were measured via an accelerometer device. |
| Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | Baseline, Month 4 (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 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | Baseline, Month 4 (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. |
Countries
United States
Participant flow
Recruitment details
Participants with symptomatic, physician diagnosed knee or hip osteoarthritis (OA) were recruited from participating primary care providers in 3 University of North Carolina clinics between March 2019 and July 2019. The first participant was enrolled on March 21, 2019 and the last participant was enrolled on July 3, 2019.
Participants by arm
| Arm | Count |
|---|---|
| OA-PCP Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | OA-PCP |
|---|---|
| Age, Continuous | 72.4 years STANDARD_DEVIATION 5.6 |
| Body Mass Index (BMI) | 33.4 kg/m^2 STANDARD_DEVIATION 7.3 |
| Education | 48 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Marital Status | 38 Participants |
| Number of Comorbid Illnesses | 4.3 illnesses STANDARD_DEVIATION 1.7 |
| Number of Joints with Arthritis Symptoms | 7.7 joints STANDARD_DEVIATION 2.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 11 Participants |
| Work Status | 17 Participants |
| Years with Arthritis Symptoms | 11.1 years STANDARD_DEVIATION 9.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week
Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer
Time frame: Baseline, Month 4 (Follow-up)
Population: 7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week | 0.78 minutes |
p-value: 0.5145t-test, 2 sided
Secondary
Change From Baseline to Month 4 for Minutes of Sedentary Activity
Minutes of sedentary activity were measured via an accelerometer device.
Time frame: Baseline, Month 4 (Follow-up)
Population: 7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 4 for Minutes of Sedentary Activity | -0.15 minutes |
p-value: 0.9858t-test, 2 sided
Secondary
Change From Baseline to Month 4 for Steps Per Day
Step counts were measured via an accelerometer device.
Time frame: Baseline, Month 4 (Follow-up)
Population: 7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 4 for Steps Per Day | 143.7 steps |
p-value: 0.3683t-test, 2 sided
Secondary
Change From Baseline to Month 4 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 4 (Follow-up)
Population: 7 participants did not complete month 4 follow-up assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale | -6.1 units on a scale |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline to Month 4 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 4 (Follow-up)
Population: 7 participants did not complete month 4 follow-up assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OA-PCP | Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale | -1.9 units on a scale |
p-value: <0.0001t-test, 2 sided