ArthritisOACareToolsNCT06988163
Osteoarthritis Care Tools for Primary Care Providers
A study testing OACareTools+ in people with Arthritis and Osteo Arthritis Knee, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this pilot study is to test OACareTools+, an intervention for healthcare providers that combines education, patient resources and support from a national organization, to help them make referrals of patients with arthritis to the Walk With Ease program. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Osteo Arthritis Knee
- What is being tested?
- OACareTools+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare provider participants: currently a healthcare provider or staff person in the UNC pilot clinic
- Patient participants: 18 years or older; received a referral to Walk With Ease from a provider at the UNC pilot clinic; agreed to participate in the phone interview on the post-Walk With Ease evaluation form
Who cannot join
- Both: non-English speaking
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: OACareTools Primary Care-Led Usability & Scalability Pilot Study (OACareTools PLUS)
The purpose of this pilot study is to test OACareTools+, an intervention for healthcare providers that combines education, patient resources and support from a national organization, to help them make referrals of patients with arthritis to the Walk With Ease program. This intervention was designed to increase referrals of patients with arthritis to the Walk With Ease program.
Read the detailed description
Participants will be clinicians (n= 50) in a primary care practice and a subset of patients (n=10). The study team will deliver education and resources to providers in a training session about Walk With Ease. After the provider training, providers will use the study resources to refer patients with arthritis to Walk With Ease. Healthcare provider participants will complete surveys after their first referral and at the end of the study (12-months). Patient participants who are referred to Walk With Ease through the OACareTools+ intervention will participate in interviews about their experience (6-weeks) with the referral process. Primary endpoints of the study will be 1) number of healthcare providers that referred patients to Walk With Ease 2) number of Walk With Ease patient participants 3) healthcare provider acceptability and feasibility 4) patient acceptability of the intervention.
- Conditions
- Arthritis, Osteo Arthritis Knee
- Being tested
- OACareTools+
- Keywords
- healthcare providers, arthritis, primary care
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OACareTools+Behavioural
Also called Walk With Ease, Camine Con Gusto
OACareTools+ is a healthcare provider intervention that combines healthcare provider education, customized patient and clinical resources, and technical support from a national organization to facilitate provider counseling on and referral to as well as patient engagement in Walk With Ease. There are 2 main parts to this intervention: 1) Healthcare provider education: The study team will deliver the provider education and resources (including information about Walk With Ease and the established referral process/smartphrase) in a presentation providers at a weekly clinician meeting and in follow-up emails. 2) Implementation: Providers will use the resources to briefly counsel patients about physical activity and Walk With Ease and use the smartphrase to refer patients to Walk With Ease. Patients will register for and participate in the online Walk With Ease program. Patients and providers can seek assistance from the national organization as needed during these processes.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare providers | Experimental | Healthcare providers will receive the intervention, OACareTools+, which involves a training session on, patient resources about, and provider referral to Walk With Ease. Receives: Behavioral: OACareTools+ |
| Patients | Experimental | A subset of patients who are referred through OACareTools+ by their provider and participate in Walk With Ease will provide feedback on their experience with the referral process to Walk With Ease. Receives: Behavioral: OACareTools+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of healthcare providers who referred patients
Healthcare providers in the pilot clinic who refer patients to the Walk With Ease program using the study referral process and resources
Measured: 12 months
Number of patients who registered for Walk With Ease
Patients from the pilot clinic who are referred to and register in the Walk With Ease program
Measured: 12 months
Healthcare provider acceptability
The Acceptability of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater acceptability; measured via electronic survey.
Measured: Measure collected up to 2 months after provider's first referral
Healthcare provider feasibility
The Feasibility of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater feasibility; measured via electronic survey.
Measured: Measure collected up to 2 months after provider's first referral
Patient acceptability
The Acceptability of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater acceptability; measured via telephone interview.
Measured: 6-weeks post- Walk With Ease registration
Patient usefulness: educational resources
During a phone interview, patients will be asked, "How helpful were the education materials given to you by your healthcare provider?" They will be asked to use a scale, 0-10, where 0 is not helpful at all and 10 is extremely helpful. Higher scores indicate greater levels of helpfulness.
Measured: 6-weeks post- Walk With Ease registration
Patient usefulness: clinician referral to Walk With Ease
During a phone interview, patients will be asked, "How helpful was it to talk with healthcare provider about physical activity and Walk With Ease?" They will be asked to use a scale, 0-10, where 0 is not helpful at all and 10 is extremely helpful. Higher scores indicate greater levels of helpfulness.
Measured: 6-weeks post- Walk With Ease registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start21 Aug 2025
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Leigh Callahan, PhD, Principal investigator, UNC Thurston Arthritis Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988163
- Sponsor's protocol ID
- 24-2284
- Other IDs
- 1 U48DP006837-01-00, 1U48DP006837-01
- Acronym
- OACareTools
- Status last verified
- Sep 2026
- First submitted
- 15 May 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that support the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. Data collected include: pre/post walking program assessments, referral count, patient engagement metrics, arthritis outcomes, satisfaction (provider and patient). Qualitative data will be available in the form of a summary.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OACareTools Primary Care-Led Usability & Scalability Pilot Study (OACareTools PLUS)
- ClinicalTrials.gov ID
- NCT06988163
- Acronym / sponsor ID
- OACareTools / 24-2284
- Conditions
- Arthritis, Osteo Arthritis Knee
- Keywords
- healthcare providers, arthritis, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to test OACareTools+, an intervention for healthcare providers that combines education, patient resources and support from a national organization, to help them make referrals of patients with arthritis to the Walk With Ease program. This intervention was designed to increase referrals of patients with arthritis to the Walk With Ease program.
Detailed description
Participants will be clinicians (n= 50) in a primary care practice and a subset of patients (n=10). The study team will deliver education and resources to providers in a training session about Walk With Ease. After the provider training, providers will use the study resources to refer patients with arthritis to Walk With Ease. Healthcare provider participants will complete surveys after their first referral and at the end of the study (12-months). Patient participants who are referred to Walk With Ease through the OACareTools+ intervention will participate in interviews about their experience (6-weeks) with the referral process. Primary endpoints of the study will be 1) number of healthcare providers that referred patients to Walk With Ease 2) number of Walk With Ease patient participants 3) healthcare provider acceptability and feasibility 4) patient acceptability of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare providers | Experimental | Behavioral: OACareTools+Healthcare providers will receive the intervention, OACareTools+, which involves a training session on, patient resources about, and provider referral to Walk With Ease. |
| Patients | Experimental | Behavioral: OACareTools+A subset of patients who are referred through OACareTools+ by their provider and participate in Walk With Ease will provide feedback on their experience with the referral process to Walk With Ease. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthcare provider participants: currently a healthcare provider or staff person in the UNC pilot clinic
- Patient participants: 18 years or older; received a referral to Walk With Ease from a provider at the UNC pilot clinic; agreed to participate in the phone interview on the post-Walk With Ease evaluation form
Key exclusion criteria (1 listed)
- Both: non-English speaking
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 |
|---|---|---|
| OACareTools+Also: Walk With Ease, Camine Con GustoOACareTools+ is a healthcare provider intervention that combines healthcare provider education, customized patient and clinical resources, and technical support from a national organization to facilitate provider counseling on and referral to as well as patient engagement in Walk With Ease. There are 2 main parts to this intervention: 1) Healthcare provider education: The study team will deliver the provider education and resources (including information about Walk With Ease and the established referral process/smartphrase) in a presentation providers at a weekly clinician meeting and in follow-up emails. 2) Implementation: Providers will use the resources to briefly counsel patients about physical activity and Walk With Ease and use the smartphrase to refer patients to Walk With Ease. Patients will register for and participate in the online Walk With Ease program. Patients and providers can seek assistance from the national organization as needed during these processes. | Behavioural | Healthcare providers, Patients |
Primary outcome
Number of healthcare providers who referred patients
Time frame: 12 months
Healthcare providers in the pilot clinic who refer patients to the Walk With Ease program using the study referral process and resources
Number of patients who registered for Walk With Ease
Time frame: 12 months
Patients from the pilot clinic who are referred to and register in the Walk With Ease program
Healthcare provider acceptability
Time frame: Measure collected up to 2 months after provider's first referral
The Acceptability of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater acceptability; measured via electronic survey.
Healthcare provider feasibility
Time frame: Measure collected up to 2 months after provider's first referral
The Feasibility of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater feasibility; measured via electronic survey.
Patient acceptability
Time frame: 6-weeks post- Walk With Ease registration
The Acceptability of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater acceptability; measured via telephone interview.
Patient usefulness: educational resources
Time frame: 6-weeks post- Walk With Ease registration
During a phone interview, patients will be asked, "How helpful were the education materials given to you by your healthcare provider?" They will be asked to use a scale, 0-10, where 0 is not helpful at all and 10 is extremely helpful. Higher scores indicate greater levels of helpfulness.
Patient usefulness: clinician referral to Walk With Ease
Time frame: 6-weeks post- Walk With Ease registration
During a phone interview, patients will be asked, "How helpful was it to talk with healthcare provider about physical activity and Walk With Ease?" They will be asked to use a scale, 0-10, where 0 is not helpful at all and 10 is extremely helpful. Higher scores indicate greater levels of helpfulness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that support the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. Data collected include: pre/post walking program assessments, referral count, patient engagement metrics, arthritis outcomes, satisfaction (provider and patient). Qualitative data will be available in the form of a summary.
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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.
Leigh Callahan, PhD principal investigator
UNC Thurston Arthritis Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OACareTools+ in people with Arthritis and Osteo Arthritis Knee, 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 2 inclusion and 1 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 24 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of healthcare providers who referred patients (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2026.