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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06706999
Enrollment
63
Registered
2024-11-27
Start date
2025-03-31
Completion date
2025-11-16
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Physical Therapy, Rehabilitation

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.

Interventions

OTHERPREVAIL 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.

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Who Receive PREVAIL Model of Care Essential ComponentsBaseline assessments (including the DAPS tool) provided 1 week before routine visit, routine visit with rheumatology clinician, and 3-month follow-up assessmentsData 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.
Percentage of Participants Who Access the Exercise Resource at Least Once During Study DurationCollected during 3-month follow-up assessmentsExercise resource utilization will be measured through patient report to determine feasibility of the PREVAIL model of care from the patient perspective. Yes/No responses from the question "Did you visit the PREVAIL exercise website?" on the PREVAIL Exercise Website User Experience survey. The percentage of "yes" responses are reported.
Average Score on the Feasibility of Intervention Measure (FIM)Collected during 3-month follow-up assessmentsThe FIM is a method for determining if a treatment or intervention can be carried out in a particular setting. It is a 4-item outcome measure. Each item is scored on a 5-point Likert scale (completely disagree = 1, completely agree = 5). Questions are averaged to produce a final score. Scores range from 1-5 with higher scores indicating higher feasibility.
Average Score on the Acceptability of Intervention Measure (AIM)Collected during 3-month follow-up assessmentsThe AIM is a 4-item outcome measure to test whether the intervention is agreeable and appealing to individuals. It is a 4-item outcome measure. Each item is scored on a 5-point Likert scale (completely disagree = 1, completely agree = 5). Questions are averaged to produce a final score. Scores range from 1-5 with higher scores indicating higher acceptability.

Secondary

MeasureTime frameDescription
Percentage of Recruitment Pool Who Enroll in the StudyEMR Review and Pre-Screening (2 months prior to appointment) to enrollment (2 months to 1 week before routine visit)The percentage of recruitment pool who pass electronic medical record (EMR) chart review and were invited for study pre-screening, then proceed to enroll in the study will be collected.
Percentage of Participants That Complete Follow-up AssessmentsAssessments provided 3 months after baseline assessment visitThe study team will track completion of each assessment through REDCap. This is necessary for determining the feasibility of a larger scale trial of the PREVAIL model of care.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLouise Thoma, DPT, PhD

University of North Carolina, Chapel Hill

Baseline characteristics

Characteristic
Age, Continuous56.9 years
STANDARD_DEVIATION 12.8
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
55 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
14 Participants
Race (NIH/OMB)
More than one race
5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
44 Participants
Region of Enrollment
United States
63 Participants
Sex/Gender, Customized
Female
54 Participants
Sex/Gender, Customized
Male
9 Participants
Sex/Gender, Customized
Non-Binary/non-conforming
0 Participants
Sex/Gender, Customized
Transgender
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 61
other
Total, other adverse events
0 / 61
serious
Total, serious adverse events
2 / 61

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026