Health TrialsbyHealthPanel

RENEW Intervention for Axial Spondyloarthritis

ConditionAxial Spondyloarthritis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • RENEW

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group 1: RENEW ProgramExperimental treatment 1 intervention
Group B: Group 2: Waitlist GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
across the 12-week period
2

Goal Attainment Scaling (GAS)

Assessed by health coach

Time frame
Weeks 0, 6, 12
3

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.

Time frame
Week 12
4

Qualitative Interviews (n=10-15 of RENEW Intervention group)

Acceptability will also be assessed through qualitative interviews with a subset of intervention participants.

Time frame
Week 12

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Spondyloarthritis Association of America

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: