OsteoarthritisNCT03780400
Physical Activity Pathway for Patients With Osteoarthritis in Primary Care (OA-PCP)
A study testing Osteoarthritis Physical Activity Care Pathway in people with Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Osteoarthritis Physical Activity Care Pathway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Physician diagnosis of knee or hip OA
- Current Joint Symptoms
- Current Weekly Physical Activity <150 minutes per week.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Thurston Arthritis Research Center
Chapel Hill, North Carolina, 27599
About this study
Official title: Physical Activity Pathway for Patients With Osteoarthritis in Primary Care
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Osteoarthritis Physical Activity Care Pathway
- Keywords
- Osteoarthritis, Knee Osteoarthritis, Hip Osteoarthritis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteoarthritis Physical Activity Care PathwayBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthritis Physical Activity Care Pathway | Experimental | 4 month physical activity (PA) counseling intervention Receives: Behavioral: Osteoarthritis Physical Activity Care Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Month 4 (Follow-up)
Secondary outcomes (4)
Change From Baseline to Month 4 for Steps Per Day
Step counts were measured via an accelerometer device.
Measured: Baseline, Month 4 (Follow-up)
Change From Baseline to Month 4 for Minutes of Sedentary Activity
Minutes of sedentary activity were measured via an accelerometer device.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 4 (Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start21 Mar 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kelli D Allen, PhD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780400
- Sponsor's protocol ID
- 18-0877
- Other IDs
- 1R21AG056568
- Status last verified
- Jul 2020
- First submitted
- 17 Dec 2018
- Last updated
- 25 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33902099Allen 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.
PubMed 32416715
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Pathway for Patients With Osteoarthritis in Primary Care
- ClinicalTrials.gov ID
- NCT03780400
- Acronym / sponsor ID
- 18-0877
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Knee Osteoarthritis, Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 25 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritis Physical Activity Care Pathway | Experimental | Behavioral: Osteoarthritis Physical Activity Care Pathway4 month physical activity (PA) counseling intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Physician diagnosis of knee or hip OA
- Current Joint Symptoms
- Current Weekly Physical Activity <150 minutes per week.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteoarthritis Physical Activity Care PathwayThe 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. | Behavioural | Osteoarthritis Physical Activity Care Pathway |
Primary outcome
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
4 secondary outcomes
Change From Baseline to Month 4 for Steps Per Day
Time frame: Baseline, Month 4 (Follow-up)
Change From Baseline to Month 4 for Minutes of Sedentary Activity
Time frame: Baseline, Month 4 (Follow-up)
Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
Time frame: Baseline, Month 4 (Follow-up)
Change From Baseline to Month 4 in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
Time frame: Baseline, Month 4 (Follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33902099Beauchamp 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.
- Derived from this study: PubMed 32416715Allen 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelli D Allen, PhD principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteoarthritis Physical Activity Care Pathway in people with Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Month 4 for Minutes of Moderate to Vigorous Intensity PA Per Week (time frame: Baseline, Month 4 (Follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03780400, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.