REACH (Restore Energy, Activity Can Help) Lupus Study

N/AActive Not RecruitingNCT06479213

Tufts Medical Center36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erythematosus Fatigue

Interventions

REACH Peer Coaching ProgramBEHAVIORAL

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.

REACH Mobile Health ApplicationBEHAVIORAL

Participants will use the the REACH mobile health application to set weekly movement goals and log physical activity.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Feasibility

Enrollment rates (subjects enrolled/eligible individuals approached).

Time frame: 6 months

Adherence

Proportions of educational modules, activity logs, and coaching sessions completed.

Time frame: 12 months

Acceptability

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.

Time frame: 12 to 24 weeks

Secondary Outcomes

Fatigue

Effect size estimate of change in fatigue using the Fatigue Severity Scale

Time frame: 12 weeks and 24 weeks