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

NCT06706999 | Completed

• 2 other identifiers: 24-11951K23AR079037
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Physical Therapy; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Percentage of participants who receive PREVAIL model of care essential components

  Data will be collected from participants and rheumatology clinicians on whether or not essential components were administered. This is necessary for assessing the feasibility of the PREVAIL model of care.

  Baseline assessments (including the DAPS tool) provided 1 week before routine visit, routine visit with rheumatology clinician, and 3-month follow-up assessments

• Percentage of participants who access the exercise resource at least once during study duration

  Exercise resource utilization will be measured through patient report and google analytics to determine feasibility of the PREVAIL model of care from the patient perspective.

  Collected during 3-month follow-up assessments

• Average score on the Feasibility of Intervention Measure (FIM)

  The FIM is a method for determining if a treatment or intervention can be carried out in a particular setting. It is a valid and reliable 4-item outcome measure scored on a 5-point Likert scale (completely disagree = 1, completely agree = 5). Higher scores indicate higher feasibility. This is essential for assessing the PREVAIL model of care from the patient perspective.

  Collected during 3-month follow-up assessments

• Average score on the Acceptability of Intervention Measure (AIM)

  The AIM is a valid and reliable 4-item outcome measure to test whether the intervention is agreeable and appealing to individuals. It is also scored on a 5-point Likert scale, with higher answers indicating higher acceptability. AIM scores will be used to assess the PREVAIL model of care from the patient perspective.

  Collected during 3-month follow-up assessments

Secondary Outcomes (2)

• Percentage of recruitment pool who enroll in the study

  EMR Review and Pre-Screening (2 months prior to appointment) to enrollment (2 months to 1 week before routine visit)

• Percentage of participants that complete follow-up assessments

  Assessments provided 3 months after baseline assessment visit

Study Arms (1)

Intervention Group

EXPERIMENTAL

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.

Other: PREVAIL model of care

Interventions

PREVAIL model of care 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Louise Thoma, DPT, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 27, 2024
• Study Start: March 31, 2025
• Primary Completion: October 17, 2025
• Study Completion: November 16, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)