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REACH (Restore Energy, Activity Can Help) Lupus Study
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 patients? 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
Conditions:
🦠 Systemic Lupus Erythematosus 🦠 Fatigue
🗓️ Study Start (Actual) 13 June 2024
🗓️ Primary Completion (Estimated) 1 February 2025
✅ Study Completion (Estimated) 1 June 2025
👥 Enrollment (Estimated) 36
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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).
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 June 2024
  • First Submitted that Met QC Criteria 24 June 2024
  • First Posted 28 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 June 2024
  • Last Update Posted 28 June 2024
  • Last Verified June 2024
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