REACH (Restore Energy, Activity Can Help) Lupus Study

Tufts University

Status: Active, not recruiting

Conditions: Fatigue; Systemic Lupus Erythematosus

Treatments: Behavioral: REACH Mobile Health Application; Behavioral: REACH Peer Coaching Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06479213

K23AR078177 (U.S. NIH Grant/Contract)

00004759

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 2 patient groups

REACH Peer Coaching Program

Experimental group

Description:

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.

Treatment:

Behavioral: REACH Peer Coaching Program

Behavioral: REACH Mobile Health Application

REACH Mobile Health Application

Active Comparator group

Description:

Participants will receive access to the REACH mobile health application which they will use during the 12 weeks of the program.

Treatment:

Behavioral: REACH Mobile Health Application