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NCT Number: NCT07836374

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.

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Key information

Conditions

Axial Spondyloarthritis Ankylosis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. Goal Attainment Scaling (GAS)

    Time frame: Weeks 0, 6, 12

    Assessed by health coach

  3. 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.

  4. 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.

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Spondyloarthritis Association of America

Registry information

Official study title

Pilot Randomized Controlled Trial of the RENEW Intervention for Axial Spondyloarthritis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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