Feasibility and Acceptability of PREVAIL (PREserving Valued Activities In Life) (NCT06706999) | Clinical Trial Compass
CompletedNot Applicable
Feasibility and Acceptability of PREVAIL (PREserving Valued Activities In Life)
United States63 participantsStarted 2025-03-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Percentage of Participants Who Access the Exercise Resource at Least Once During Study Duration
Timeframe: Collected during 3-month follow-up assessments
3
Average Score on the Feasibility of Intervention Measure (FIM)
Timeframe: Collected during 3-month follow-up assessments
4
Average Score on the Acceptability of Intervention Measure (AIM)
Timeframe: Collected during 3-month follow-up assessments