Fatigue, Systemic Lupus Erythematosus
Conditions
Keywords
Physical activity, Peer coaching, Mobile health application, Chronic disease self-management
Brief summary
The goal of this clinical trial is to pilot test the REACH peer coaching program for fatigue in people with systemic lupus erythematosus. The main questions it aims to answer are: 1. Is the REACH program feasible and acceptable to participants? 2. What is the impact of the REACH program on fatigue? Researchers will compare the REACH peer coaching program to the REACH mobile health application to see if the REACH program works to reduce fatigue. Participants will: * Use the REACH mobile health application to set weekly movement goals and log daily physical activity * Meet weekly with their REACH peer coach (if they have one) to talk about their movement goals and progress * Complete weekly symptom surveys * Complete study surveys when they start the program, in the middle of the program, at the end of the program, and 12 weeks after the program ends * Participate in an interview to provide feedback on the program
Interventions
BEHAVIORALREACH Peer Coaching Program
The REACH Peer Coaching Program consists of weekly coaching calls conducted over video teleconference. Coaches will use motivational interviewing to help participants formulate and work towards movement goals.
BEHAVIORALREACH Mobile Health Application
Participants will use the the REACH mobile health application to set weekly movement goals and log physical activity.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of systemic lupus erythematosus based on 2019 American College of Rheumatology classification criteria * ≥ 18 years of age * English-speaking * Ownership of a smartphone * Physician's permission to participate in the study (including engagement in physical activity) * Fatigue Severity Scale score ≥ 4
Exclusion criteria
* Inability to consent or comply with the study protocol (cognitively impaired adults).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | 6 months | Enrollment rates (subjects enrolled/eligible individuals approached). |
| Adherence | 12 months | Proportions of educational modules, activity logs, and coaching sessions completed. |
| Acceptability | 12 to 24 weeks | Net Promoter Scores for the educational modules, REACH app, and REACH peer coaching intervention. Interviews exploring the acceptability of study procedures (e.g. data collection methods, study assessments, functionality of the mobile app) and engagement with educational modules and peer coaches. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 12 weeks and 24 weeks | Effect size estimate of change in fatigue using the Fatigue Severity Scale |
Countries
United States
Outcome results
None listed