Rheumatoid Arthritis (RA)NCT06706999
Feasibility and Acceptability of PREVAIL (PREserving Valued Activities In Life)
A study testing PREVAIL model of care in people with Rheumatoid Arthritis (RA) and Arthritis, Rheumatoid (RA), run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA), Arthritis, Rheumatoid (RA)
- What is being tested?
- PREVAIL model of care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2025to 16 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Pilot Study of Feasibility and Acceptability of PREVAIL (PREserving Valued Activities In Life)
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.
Read the 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.
- Being tested
- PREVAIL model of care
- Keywords
- Physical Therapy, Rehabilitation
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREVAIL model of careOther
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.
- Screening tool (DAPS) completed at baseline to determine current level of limitation with valued life activities.
- Recommendation to rheumatology clinician based on screening results to provide exercise resource and/or recommend a PT consult call during routine visit.
- Exercise resource (PREVAIL website) provided to all participants by their rheumatology clinician at their routine visit.
- 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.
- Referral to PT. Only applicable if determined by study physical therapist to meet priority requirements.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PREVAIL model of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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 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.
Measured: Collected during 3-month follow-up assessments
Average Score on the Acceptability of Intervention Measure (AIM)
The 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.
Measured: Collected during 3-month follow-up assessments
Secondary outcomes (2)
Percentage of Recruitment Pool Who Enroll in the Study
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.
Measured: 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
The 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.
Measured: Assessments provided 3 months after baseline assessment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start31 Mar 2025
- Primary completion17 Oct 2025
- Study completion16 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Louise Thoma, DPT, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706999
- Sponsor's protocol ID
- 24-1195
- Other IDs
- 1K23AR079037
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2024
- Last updated
- 27 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Feasibility and Acceptability of PREVAIL (PREserving Valued Activities In Life)
- ClinicalTrials.gov ID
- NCT06706999
- Acronym / sponsor ID
- 24-1195
- Keywords
- Physical Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 16 Nov 2025 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Posted 27 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: PREVAIL model of careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREVAIL model of careComponents 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. | Other | Intervention Group |
Primary outcome
Percentage of Participants Who Receive PREVAIL Model of Care Essential Components
Time frame: Baseline assessments (including the DAPS tool) provided 1 week before routine visit, routine visit with rheumatology clinician, and 3-month follow-up assessments
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.
Percentage of Participants Who Access the Exercise Resource at Least Once During Study Duration
Time frame: Collected during 3-month follow-up assessments
Exercise 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)
Time frame: Collected during 3-month follow-up assessments
The 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)
Time frame: Collected during 3-month follow-up assessments
The 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.
2 secondary outcomes
Percentage of Recruitment Pool Who Enroll in the Study
Time frame: 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
Time frame: Assessments provided 3 months after baseline assessment visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Thoma, DPT, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREVAIL model of care in people with Rheumatoid Arthritis (RA) and Arthritis, Rheumatoid (RA), run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Receive PREVAIL Model of Care Essential Components (time frame: Baseline assessments (including the DAPS tool) provided 1 week before routine visit, routine visit with rheumatology clinician, and 3-month follow-up assessments). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.