Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06479213

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 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Behavior Connective Tissue Diseases Fatigue Immune System Diseases Lupus Erythematosus, Systemic Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

REACH Peer Coaching Program

Behavioral

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 Application

Behavioral

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

Primary outcomes

  1. Feasibility

    Time frame: 6 months

    Enrollment rates (subjects enrolled/eligible individuals approached).

  2. Adherence

    Time frame: 12 months

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

  3. Acceptability

    Time frame: 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 outcomes

  1. Fatigue

    Time frame: 12 weeks and 24 weeks

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

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Acronym: REACH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2024
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.