REACH (Restore Energy, Activity Can Help) Lupus Study

NCT ID: NCT06479213

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-13

Study Completion Date

2025-09-01

Brief Summary

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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

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Conditions

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Systemic Lupus Erythematosus Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

REACH Peer Coaching Program

Intervention Type 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

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

REACH Mobile Health Application

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

REACH Mobile Health Application

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Tufts Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Gulati N, Singh K, Morrissey E, Calvache P, Rose-Smith J, Gore-Massy M, Chiu F, Trinquart L, Navarro-Millan I, Folta S, Kasturi S. Study protocol for a randomized controlled trial to pilot Restore Energy, Activity Can Help (REACH): an mHealth-enabled peer coaching intervention for fatigue in systemic lupus erythematosus. Contemp Clin Trials Commun. 2025 Jun 7;46:101508. doi: 10.1016/j.conctc.2025.101508. eCollection 2025 Aug.

Reference Type DERIVED
PMID: 40548142 (View on PubMed)

Related Links

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Other Identifiers

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K23AR078177

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00004759

Identifier Type: -

Identifier Source: org_study_id

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