RENEW Intervention for Axial Spondyloarthritis

N/ANot Yet RecruitingNCT07836374

University of Michigan40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Axial Spondyloarthritis

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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

Goal Attainment Scaling (GAS)

Assessed by health coach

Time frame: 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.

Time frame: 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.

Time frame: Week 12

Central Contacts

Elizabeth Haro

CONTACT

734-998-7124 elharo@umich.edu

Data from ClinicalTrials.gov

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