Osteoarthritis Care Tools for Primary Care Providers

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Both: non-English speaking

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06988163
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of North Carolina, Chapel Hill
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Leigh Callahan, PhD
Principal Investigator Affiliation	UNC Thurston Arthritis Research Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, U.S. Fed
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Arthritis, Osteo Arthritis Knee

Additional Details

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.

Arms & Interventions

Arms

Experimental: Healthcare providers

Healthcare providers will receive the intervention, OACareTools+, which involves a training session on, patient resources about, and provider referral to Walk With Ease.

Experimental: Patients

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.

Interventions

Behavioral: - OACareTools+

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UNC Thurston Arthritis Research Center, Chapel Hill, North Carolina

Status

Address

UNC Thurston Arthritis Research Center

Chapel Hill, North Carolina, 27599

Site Contact

Katie Huffman

katie_huffman@med.unc.edu

919-962-5145

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