RENEW Intervention for Axial Spondyloarthritis

NCT07836374 | Not Yet Recruiting

• 1 other identifier: HUM00298986
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 people like the RENEW program and 3) to understand if it helps with symptom management and disease burden.

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (4)

• 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

  across the 12-week period

• Goal Attainment Scaling (GAS)

  Assessed by health coach

  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.

  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.

  Week 12

Study Arms (2)

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.

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.

Interventions

RENEW OTHER

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.

Group 1: RENEW Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Spondyloarthritis Association of America: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Susan Murphy, ScD, OTR

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Yen Chen, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Haro

CONTACT

734-998-7124; elharo@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)