Feasibility and Acceptability of PREVAIL (PREserving Valued Activities In Life)

NCT ID: NCT06706999

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2025-11-16

Brief Summary

The goal of this clinical trial is to learn if the PREVAIL model of care is a feasible way to integrate rehabilitation into routine rheumatology care for adults with rheumatoid arthritis (RA). The model of care consists of three essential components: a screening tool (Daily Activity and Participation Screen (DAPS)), a recommendation to the rheumatology clinician regarding rehabilitation referral and exercise, and an online exercise resource tailored for adults with RA.

Participants will complete baseline assessments before their scheduled routine visit with a rheumatology clinician, attend their visit, receive their exercise and/or rehabilitation recommendation, and complete follow-up assessments roughly three months after their visit. Based on a participant's DAPS score, they may be recommended to complete a brief consultation call with a study physical therapist, who may or may not refer them to physical therapy (PT). Participants may also be asked to elaborate on their experience with the PREVAIL model of care in an interview.

Detailed Description

Physical therapy and exercise interventions reduce impairment by improving pain, weakness, and fatigue. Despite continued high prevalence of functional limitations, often related to pain, weakness, and/or fatigue, PT and exercise are underutilized for adults with RA in the US. These low utilization rates do not align with the high impairment rate (up to 92%). Rheumatologists are without clear guidance regarding when to refer for PT, which may contribute to low utilization.

Physical activity and exercise are unequivocally beneficial for adults with RA, yet recommendations from providers are often limited, generic, or vague. Adults with RA have lower physical activity levels than the general population, including those with low symptom activity. Patients want information from a trusted expert who understands RA. Further, receiving a provider recommendation for exercise is strongly associated with engagement. Systematically integrating exercise recommendations, tailored to RA, in routine RA care is needed to increase exercise and delay limitations in discretionary activities.

The PREVAIL model of care was developed to preserve valued activities in life and facilitate the integration of PT for adults with RA who need it. The preliminary version of the PREVAIL model of care was developed based on current literature, which consistently identified a need for non-pharmacological treatment strategies for RA, and had three primary components: (1) Daily Activity and Participation Screening. Participants completed the S-VLA and were categorized into current level of limitation with valued life activities. This component was critical because there are currently no systematic methods to guide intervention in RA care in the US. (2) Recommendation for Referral to PT. The rheumatology clinician received a recommendation to refer to PT for patients with or at risk for limitation. (3). Exercise Guidance. All participants received evidence-based, RA-specific exercise guidance via web-based videos and links to self-directed and community resources that were developed and curated by previous research. This component was critical because exercise preserves function in adults with RA, and these patients want exercise guidance from trusted sources that acknowledge their RA.

This study builds on preparatory survey and interview studies to help refine the PREVAIL model of care before testing in this pilot clinical trial. The investigators have added an interim PT consultation call with a study physical therapist as the initial referral from the rheumatology clinician, and refined the timeline with which assessments are administered.

Conditions

Rheumatoid Arthritis (RA); Arthritis, Rheumatoid (RA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Group

Participants will all receive a recommendation from their rheumatology provider based on their DAPS score. Recommendations will consist of an exercise resource and potentially a referral for a brief PT consultation call.

Group Type: EXPERIMENTAL

PREVAIL model of care

Intervention Type: OTHER

Components 1, 2, and 3 are essential components that all participants will receive. Components 4 and 5 are based on the results of either the DAPS tool or the PT consultation call.

1. Screening tool (DAPS) completed at baseline to determine current level of limitation with valued life activities.

2. Recommendation to rheumatology clinician based on screening results to provide exercise resource and/or recommend a PT consult call during routine visit.

3. Exercise resource (PREVAIL website) provided to all participants by their rheumatology clinician at their routine visit.

4. Brief consultation call with a study physical therapist to determine level of priority for PT referral. Only applicable for those with/at risk for limitation with valued life activities.

5. Referral to PT. Only applicable if determined by study physical therapist to meet priority requirements.

Interventions

PREVAIL model of care

Components 1, 2, and 3 are essential components that all participants will receive. Components 4 and 5 are based on the results of either the DAPS tool or the PT consultation call.

1. Screening tool (DAPS) completed at baseline to determine current level of limitation with valued life activities.

2. Recommendation to rheumatology clinician based on screening results to provide exercise resource and/or recommend a PT consult call during routine visit.

3. Exercise resource (PREVAIL website) provided to all participants by their rheumatology clinician at their routine visit.

4. Brief consultation call with a study physical therapist to determine level of priority for PT referral. Only applicable for those with/at risk for limitation with valued life activities.

5. Referral to PT. Only applicable if determined by study physical therapist to meet priority requirements.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Over the age of 18
• Clinician diagnosis of RA as defined by International Classification of Diseases 10 (ICD-10) code
• Receiving routine care from a UNC rheumatology clinician
• Have an upcoming scheduled visit with a UNC rheumatology clinician for a routine follow up

Exclusion Criteria

• No documented diagnosis of RA
• Under the age of 18
• Significant cognitive impairment
• Condition that restricts ability to complete surveys and patient reported outcomes
• Severe hearing or visual impairment
• Serious/terminal illness as indicated by referral to hospice or palliative care
• Unable to speak or read English
• Current participation in any other study related to RA
• Current or recent (within the last six months) participation in PT
• Recent (within the last 6 months) major surgery requiring overnight hospital admission and/or resulting in functional loss, requiring rehabilitation
• Upcoming (within the next 6 months) major surgery requiring overnight hospital admission and/or resulting in functional loss, requiring rehabilitation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise Thoma, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1K23AR079037

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-1195

Identifier Type: -

Identifier Source: org_study_id