REACH (Restore Energy, Activity Can Help) Lupus Study (REACH)

July 16, 2025 updated by: Tufts Medical Center

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: REACH Peer Coaching Program
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.
Behavioral: REACH Mobile Health Application
Participants will use the the REACH mobile health application to set weekly movement goals and log physical activity.
Active Comparator: 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.
Behavioral: REACH Mobile Health Application
Participants will use the the REACH mobile health application to set weekly movement goals and log physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 6 months
Enrollment rates (subjects enrolled/eligible individuals approached).
6 months
Adherence
Time Frame: 12 months
Proportions of educational modules, activity logs, and coaching sessions completed.
12 months
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.
12 to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: 12 weeks and 24 weeks
Effect size estimate of change in fatigue using the Fatigue Severity Scale
12 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

June 13, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00004759
  • K23AR078177 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fatigue

Clinical Trials on REACH Peer Coaching Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe