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Physical Activity Pathway for Patients With Osteoarthritis in Primary Care (OA-PCP)

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ClinicalTrials.gov Identifier: NCT03780400
Recruitment Status : Completed
First Posted : December 19, 2018
Results First Posted : August 25, 2020
Last Update Posted : August 25, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Behavioral: Osteoarthritis Physical Activity Care Pathway Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Activity Pathway for Patients With Osteoarthritis in Primary Care
Actual Study Start Date : March 21, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: Osteoarthritis Physical Activity Care Pathway
4 month physical activity (PA) counseling intervention
Behavioral: Osteoarthritis 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.




Primary Outcome Measures :
  1. Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week [ Time Frame: Baseline, Month 4 (Follow-up) ]
    Minutes of moderate to vigorous intensity physical activity (MVPA) per week measured via accelerometer


Secondary Outcome Measures :
  1. Change From Baseline to Month 4 for Steps Per Day [ Time Frame: Baseline, Month 4 (Follow-up) ]
    Step counts were measured via an accelerometer device.

  2. Change From Baseline to Month 4 for Minutes of Sedentary Activity [ Time Frame: Baseline, Month 4 (Follow-up) ]
    Minutes of sedentary activity were measured via an accelerometer device.

  3. Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale [ Time Frame: 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.

  4. Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale [ Time Frame: 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780400


Locations
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United States, North Carolina
UNC Thurston Arthritis Research Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Kelli D Allen, PhD UNC Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03780400    
Other Study ID Numbers: 18-0877
1R21AG056568 ( U.S. NIH Grant/Contract )
First Posted: December 19, 2018    Key Record Dates
Results First Posted: August 25, 2020
Last Update Posted: August 25, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Osteoarthritis
Knee Osteoarthritis
Hip Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases