Osteoarthritis Care Tools for Primary Care Providers

NCT06988163 | Enrolling By Invitation

• 3 other identifiers: 24-22841 U48DP006837-01-001U48DP006837-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. This intervention was designed to increase referrals of patients with arthritis to the Walk With Ease program.

Conditions

Arthritis; Osteo Arthritis Knee

Keywords

healthcare providers; arthritis; primary care

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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.

  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.

  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.

  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.

  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.

  6-weeks post- Walk With Ease registration

Study Arms (2)

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.

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.

Behavioral: OACareTools+

Interventions

OACareTools+ BEHAVIORAL

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.

Also known as: Walk With Ease, Camine Con Gusto

Healthcare providers; Patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Both: non-English speaking

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

UNC Thurston Arthritis Research Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Arthritis

Interventions

Walking; methyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Leigh Callahan, PhD

  UNC Thurston Arthritis Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 and continuing for 36 months following publication. Research study records will be maintained for no less than 6 years following the completion of the study.
• Access Criteria: Approved IRB, IEC, or REB and an executed a data use/sharing agreement with UNC.

Locations

US (1)