Axial SpondyloarthritisNCT07836374
RENEW Intervention for Axial Spondyloarthritis
A study testing RENEW in people with Axial Spondyloarthritis, run by University of Michigan at 1 site in United States.
Trial summary
The researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have axial spondyloarthritis (axSpA). There are 3 main reasons the researchers are doing this study: 1) to test how easy it is for people with spondyloarthritis to use the RENEW program; 2) to assess whether… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- RENEW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Physician-diagnosed axSpA (including non-radiographic axSpA)
- Have moderate to severe fatigue (average of ≥4/7 on the Fatigue Severity Scale)
- Access to a computer, tablet, or smartphone with internet connection
- Ability to speak and read English
- Willingness to participate in virtual Zoom coaching sessions and complete online assessments
- Interested in making some changes and trying new ways to improve health and well-being
Who cannot join
- Currently enrolled in other clinical trials
- Currently undergoing structured rehabilitation or psychological treatment for major depressive disorder
- Significant cognitive impairment that would prevent informed consent or participation
- Severe psychiatric illness that would contraindicate participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Elizabeth Haro, 734-998-7124, elharo@umich.edu
Susan Murphy, ScD, OTR
About this study
Official title: Pilot Randomized Controlled Trial of the RENEW Intervention for Axial Spondyloarthritis
The researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have axial spondyloarthritis (axSpA). There are 3 main reasons the researchers are doing this study: 1) to test how easy it is for people with spondyloarthritis to use the RENEW program; 2) to assess whether people like the RENEW program and 3) to understand if it helps with symptom management and disease burden.
- Conditions
- Axial Spondyloarthritis
- Being tested
- RENEW
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RENEWOther
RENEW is a 12-week, peer-led, web-based program to help people with spondyloarthritis learn skills that can be used to manage disease symptoms and improve well-being. It includes:
A website that includes information, worksheets, tools, and information from other people with spondyloarthritis 9 calls with a peer health coach, beginning with weekly calls for the first 6 weeks, and every other week for the last 6 weeks of the program. We will use telehealth platforms (like Zoom) for these calls. We will record them so we can track how well the peer health coaches are following the program. Each call will last no more than 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: RENEW Program | Experimental | Participants placed in this group will be assigned a peer health coach to help guide them through the RENEW program right away. Peer health coaches are people on the study team with spondyloarthritis.
In addition, approximately 10 to 15 people from this group will be invited to take part in an optional 30-minute interview after the program ends, to share feedback about their experience with RENEW. If invited, participating in this interview is entirely voluntary. Receives: Other: RENEW |
| Group 2: Waitlist Group | No intervention | If placed in this group, participants will receive access to the RENEW website at the end of the 12-week study period. At the end of the 12 weeks, participants will be offered the option to have 1 peer health coaching session with a peer health coach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
attendance at peer health coaching sessions among RENEW intervention participants.
Assessed using the Goal Attainment Scaling (GAS) method, which measures the extent to which participants achieved their individualized goals
Measured: across the 12-week period
Goal Attainment Scaling (GAS)
Assessed by health coach
Measured: Weeks 0, 6, 12
Theoretical Framework of Acceptability (TFA) score (RENEW Intervention group)
12-item measure assessing affective attitude, burden, perceived effectiveness, and self-efficacy. An average of item scores >4 out of 5 has been established as indicating high acceptability.
Measured: Week 12
Qualitative Interviews (n=10-15 of RENEW Intervention group)
Acceptability will also be assessed through qualitative interviews with a subset of intervention participants.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start22 Oct 2026
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, randomized controlled pilot trial with a 1:1 allocation ratio comparing the RENEW intervention group to a waitlist control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Spondyloarthritis Association of America
- Responsible party
- Principal investigator, Susan Murphy, University of Michigan
- Investigators
- Susan Murphy, ScD, OTR, Principal investigator, University of MichiganYen Chen, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836374
- Sponsor's protocol ID
- HUM00298986
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of the RENEW Intervention for Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT07836374
- Acronym / sponsor ID
- HUM00298986
- Conditions
- Axial Spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Spondyloarthritis Association of America
- Study start
- 22 Oct 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have axial spondyloarthritis (axSpA). There are 3 main reasons the researchers are doing this study: 1) to test how easy it is for people with spondyloarthritis to use the RENEW program; 2) to assess whether people like the RENEW program and 3) to understand if it helps with symptom management and disease burden.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center, randomized controlled pilot trial with a 1:1 allocation ratio comparing the RENEW intervention group to a waitlist control group.
| Arm | Type | Receives |
|---|---|---|
| Group 1: RENEW Program | Experimental | Other: RENEWParticipants placed in this group will be assigned a peer health coach to help guide them through the RENEW program right away. Peer health coaches are people on the study team with spondyloarthritis. In addition, approximately 10 to 15 people from this group will be invited to take part in an optional 30-minute interview after the program ends, to share feedback about their experience with RENEW. If invited, participating in this interview is entirely voluntary. |
| Group 2: Waitlist Group | No intervention | –If placed in this group, participants will receive access to the RENEW website at the end of the 12-week study period. At the end of the 12 weeks, participants will be offered the option to have 1 peer health coaching session with a peer health coach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Physician-diagnosed axSpA (including non-radiographic axSpA)
- Have moderate to severe fatigue (average of ≥4/7 on the Fatigue Severity Scale)
- Access to a computer, tablet, or smartphone with internet connection
- Ability to speak and read English
- Willingness to participate in virtual Zoom coaching sessions and complete online assessments
Key exclusion criteria (4 listed)
- Currently enrolled in other clinical trials
- Currently undergoing structured rehabilitation or psychological treatment for major depressive disorder
- Significant cognitive impairment that would prevent informed consent or participation
- Severe psychiatric illness that would contraindicate participation
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 |
|---|---|---|
| RENEWRENEW is a 12-week, peer-led, web-based program to help people with spondyloarthritis learn skills that can be used to manage disease symptoms and improve well-being. It includes: A website that includes information, worksheets, tools, and information from other people with spondyloarthritis 9 calls with a peer health coach, beginning with weekly calls for the first 6 weeks, and every other week for the last 6 weeks of the program. We will use telehealth platforms (like Zoom) for these calls. We will record them so we can track how well the peer health coaches are following the program. Each call will last no more than 30 minutes. | Other | Group 1: RENEW Program |
Primary outcome
attendance at peer health coaching sessions among RENEW intervention participants.
Time frame: across the 12-week period
Assessed using the Goal Attainment Scaling (GAS) method, which measures the extent to which participants achieved their individualized goals
Goal Attainment Scaling (GAS)
Time frame: Weeks 0, 6, 12
Assessed by health coach
Theoretical Framework of Acceptability (TFA) score (RENEW Intervention group)
Time frame: Week 12
12-item measure assessing affective attitude, burden, perceived effectiveness, and self-efficacy. An average of item scores >4 out of 5 has been established as indicating high acceptability.
Qualitative Interviews (n=10-15 of RENEW Intervention group)
Time frame: Week 12
Acceptability will also be assessed through qualitative interviews with a subset of intervention participants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Susan Murphy, ScD, OTR principal investigator
University of Michigan
Yen Chen, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RENEW in people with Axial Spondyloarthritis, run by University of Michigan 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Haro (734-998-7124, elharo@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
attendance at peer health coaching sessions among RENEW intervention participants. (time frame: across the 12-week period). 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 29 Oct 2026.