Trial Outcomes & Findings for Feasibility and Acceptability of PREVAIL (PREserving Valued Activities In Life) (NCT NCT06706999)
NCT ID: NCT06706999
Last Updated: 2026-07-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
Baseline assessments (including the DAPS tool) provided 1 week before routine visit, routine visit with rheumatology clinician, and 3-month follow-up assessments
Results posted on
2026-07-27
Participant Flow
Participant milestones
| Measure |
PREVAIL Model of Care
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.
PREVAIL 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.
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|---|---|
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Overall Study
STARTED
|
63
|
|
Overall Study
Completed Baseline
|
61
|
|
Overall Study
Completed 3-month Follow-Up
|
51
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data were not collected for the two participants that did not complete Baseline.
Baseline characteristics by cohort
| Measure |
PREVAIL Model of Care
n=63 Participants
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.
PREVAIL 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.
|
|---|---|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 12.8 • n=61 Participants • Age data were not collected for the two participants that did not complete Baseline.
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|
Sex/Gender, Customized
Female
|
54 Participants
n=63 Participants
|
|
Sex/Gender, Customized
Male
|
9 Participants
n=63 Participants
|
|
Sex/Gender, Customized
Transgender
|
0 Participants
n=63 Participants
|
|
Sex/Gender, Customized
Non-Binary/non-conforming
|
0 Participants
n=63 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=63 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=63 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=63 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=63 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=63 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=63 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=63 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=63 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=63 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=63 Participants
|
|
Region of Enrollment
United States
|
63 Participants
n=63 Participants
|
PRIMARY outcome
Timeframe: Baseline 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.
Outcome measures
| Measure |
PREVAIL Model of Care
n=63 Participants
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.
PREVAIL 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.
|
|---|---|
|
Percentage of Participants Who Receive PREVAIL Model of Care Essential Components
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96.8 percentage of participants
|
PRIMARY outcome
Timeframe: Collected 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.
Outcome measures
| Measure |
PREVAIL Model of Care
n=51 Participants
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.
PREVAIL 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.
|
|---|---|
|
Percentage of Participants Who Access the Exercise Resource at Least Once During Study Duration
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54.9 percentage of participants
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PRIMARY outcome
Timeframe: Collected during 3-month follow-up assessmentsPopulation: Data are not completed for one participant who did not complete the 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.
Outcome measures
| Measure |
PREVAIL Model of Care
n=50 Participants
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.
PREVAIL 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.
|
|---|---|
|
Average Score on the Feasibility of Intervention Measure (FIM)
|
4.0 score on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Collected during 3-month follow-up assessmentsPopulation: Data are not completed for one participant who did not complete the 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.
Outcome measures
| Measure |
PREVAIL Model of Care
n=50 Participants
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.
PREVAIL 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.
|
|---|---|
|
Average Score on the Acceptability of Intervention Measure (AIM)
|
4.0 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: EMR Review and Pre-Screening (2 months prior to appointment) to enrollment (2 months to 1 week before routine visit)Population: The Overall Number of Participants Analyzed includes all individuals who were EMR-eligible and invited to pre-screen for participation.
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.
Outcome measures
| Measure |
PREVAIL Model of Care
n=276 Participants
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.
PREVAIL 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.
|
|---|---|
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Percentage of Recruitment Pool Who Enroll in the Study
|
22.8 percentage of recruitment pool enrolled
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SECONDARY outcome
Timeframe: Assessments 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.
Outcome measures
| Measure |
PREVAIL Model of Care
n=61 Participants
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.
PREVAIL 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.
|
|---|---|
|
Percentage of Participants That Complete Follow-up Assessments
|
83.6 percentage of participants
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Adverse Events
PREVAIL Model of Care
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PREVAIL Model of Care
n=61 participants at risk
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.
PREVAIL 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.
|
|---|---|
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Cardiac disorders
Exacerbated heart failure
|
1.6%
1/61 • Number of events 1 • Adverse events were assessed from informed consent through study completion (up to 6 months per participant). Non-serious adverse events were collected through 7 days after the participant's last study participation date, and serious adverse events were collected through 30 days after the participant's last study participation date.
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Gastrointestinal disorders
Suspected pancreatitis
|
1.6%
1/61 • Number of events 1 • Adverse events were assessed from informed consent through study completion (up to 6 months per participant). Non-serious adverse events were collected through 7 days after the participant's last study participation date, and serious adverse events were collected through 30 days after the participant's last study participation date.
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Other adverse events
Adverse event data not reported
Additional Information
Louise Thoma, PhD
University of North Carolina at Chapel Hill
Phone: 919-843-7317
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place