REACH (Restore Energy, Activity Can Help) Lupus Study

Not Applicable

Active, not recruiting

• Conditions: Fatigue; Systemic Lupus Erythematosus
• Interventions: Behavioral: REACH Mobile Health Application; Behavioral: REACH Peer Coaching Program

• Registration Number: NCT06479213
• Lead Sponsor: Tufts Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-13
• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-24
• Study First Posted: 2024-06-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-05
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REACH Mobile Health Application	REACH Mobile Health Application	Participants will receive access to the REACH mobile health application which they will use during the 12 weeks of the program.
REACH Peer Coaching Program	REACH Peer Coaching Program	Participants will receive access to the REACH mobile health application and a REACH peer coach with whom they will meet weekly during the 12 weeks of the program.
REACH Peer Coaching Program	REACH Mobile Health Application	Participants will receive access to the REACH mobile health application and a REACH peer coach with whom they will meet weekly during the 12 weeks of the program.

Primary Outcome Measures

Name	Time	Method
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.
Feasibility	6 months	Enrollment rates (subjects enrolled/eligible individuals approached).
Adherence	12 months	Proportions of educational modules, activity logs, and coaching sessions completed.

Secondary Outcome Measures

Name	Time	Method
Fatigue	12 weeks and 24 weeks	Effect size estimate of change in fatigue using the Fatigue Severity Scale

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States