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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG056568 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteoarthritis Physical Activity Care Pathway | Experimental | 4 month physical activity (PA) counseling intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteoarthritis Physical Activity Care Pathway | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Month 4 (Follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 4 for Steps Per Day | Step counts were measured via an accelerometer device. | Baseline, Month 4 (Follow-up) |
| Change From Baseline to Month 4 for Minutes of Sedentary Activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelli D Allen, PhD | UNC Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Thurston Arthritis Research Center | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33902099 | Derived | Beauchamp T, Arbeeva L, Cleveland RJ, Golightly YM, Hales DP, Hu DG, Allen KD. Accelerometer-Based Physical Activity Patterns and Associations With Outcomes Among Individuals With Osteoarthritis. J Clin Rheumatol. 2022 Mar 1;28(2):e415-e421. doi: 10.1097/RHU.0000000000001750. | |
| 32416715 | Derived | Allen K, Vu MB, Callahan LF, Cleveland RJ, Gilbert AL, Golightly YM, Griesemer I, Grimm K, Hales DP, Hu DG, Huffman K, Nelson AE, Pathak A, Rees J, Rethorn ZD, Wandishin AE. Osteoarthritis physical activity care pathway (OA-PCP): results of a feasibility trial. BMC Musculoskelet Disord. 2020 May 16;21(1):308. doi: 10.1186/s12891-020-03339-6. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | OA-PCP | Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | OA-PCP | Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data | Posted | Mean | 95% Confidence Interval | minutes | Baseline, Month 4 (Follow-up) |
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Data was collected starting at baseline to 4 months, ending at participants' final follow up time point.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OA-PCP | Participants received the Osteoarthritis Physical activity Care Pathway (OA-PCP) intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelli D. Allen, PhD | University of North Carolina at Chapel Hill | 919-966-0558 | kdallen@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2020 | Jul 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Minutes of sedentary activity were measured via an accelerometer device.
| Baseline, Month 4 (Follow-up) |
| 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. | Baseline, Month 4 (Follow-up) |
| 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. | Baseline, Month 4 (Follow-up) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Education | Participants reporting at least some college. | Count of Participants | Participants |
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| Marital Status | Participants reporting married or living with partner. | Count of Participants | Participants |
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| Work Status | Participants reporting working full or part time. | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Number of Comorbid Illnesses | Participants reported if they have or do not have these health conditions: heart disease, high blood pressure, lung disease, diabetes, ulcer/stomach diseases, kidney disease, liver disease, anemia or other blood diseases, cancer, depression, osteoarthritis/degenerative arthritis, back pain, rheumatoid arthritis or other health conditions (participant can report up to 3 other health conditions). Possible range 0 to 16. | Mean | Standard Deviation | illnesses |
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| Years with Arthritis Symptoms | Mean | Standard Deviation | years |
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| Number of Joints with Arthritis Symptoms | Mean | Standard Deviation | joints |
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| Secondary | Change From Baseline to Month 4 for Steps Per Day | Step counts were measured via an accelerometer device. | 7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data | Posted | Mean | 95% Confidence Interval | steps | Baseline, Month 4 (Follow-up) |
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| Secondary | Change From Baseline to Month 4 for Minutes of Sedentary Activity | Minutes of sedentary activity were measured via an accelerometer device. | 7 participants did not complete month 4 follow-up assessment and 11 participants had inadequate physical activity data | Posted | Mean | 95% Confidence Interval | minutes | Baseline, Month 4 (Follow-up) |
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| 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. | 7 participants did not complete month 4 follow-up assessment | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Month 4 (Follow-up) |
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| 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. | 7 participants did not complete month 4 follow-up assessment | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Month 4 (Follow-up) |
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| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
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