Clinical trial NCT06706999: Feasibility and Acceptability of PREVAIL (PREserving Valued Activities In Life)
Official title: Pilot Study of Feasibility and Acceptability of PREVAIL (PREserving Valued Activities In Life)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Rheumatoid Arthritis (RA)
Arthritis, Rheumatoid (RA)
Keywords: Physical Therapy
Rehabilitation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2024-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 surgery (within the last six months)
* Upcoming surgery (within the next six months)

Primary outcomes:
measure: Percentage of participants who receive PREVAIL model of care essential components
timeFrame: Baseline assessments (including the DAPS tool) provided 1 week before routine visit, routine visit with rheumatology clinician, and 3-month follow-up assessments
measure: Percentage of participants who access the exercise resource at least once during study duration
timeFrame: Routine visit in which the exercise resource is provided to end of study at 5 months
measure: Average score on the Feasibility of Intervention Measure (FIM)
timeFrame: Collected during 3-month follow-up assessments
measure: Average score on the Acceptability of Intervention Measure (AIM)
timeFrame: Collected during 3-month follow-up assessments
Secondary outcomes:
measure: Percentage of recruitment pool who enroll in the study
timeFrame: EMR Review and Pre-Screening (2 months prior to appointment) to enrollment (2 months to 1 week before routine visit)
measure: Percentage of participants that complete follow-up assessments
timeFrame: Assessments provided 3 months after baseline assessment visit
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Louise Thoma, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: