NCT06479213

Brief Summary

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:

  • 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 20, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

June 18, 2024

Last Update Submit

July 16, 2025

Conditions

Systemic Lupus ErythematosusFatigue

Keywords

Physical activityPeer coachingMobile health applicationChronic disease self-management

Outcome Measures

Primary Outcomes (3)

  • Feasibility

    Enrollment rates (subjects enrolled/eligible individuals approached).

    6 months

  • Adherence

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

    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.

    12 to 24 weeks

Secondary Outcomes (1)

  • Fatigue

    12 weeks and 24 weeks

Study Arms (2)

REACH Peer Coaching Program

EXPERIMENTAL

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 ProgramBehavioral: REACH Mobile Health Application

REACH Mobile Health Application

ACTIVE COMPARATOR

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

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 Peer Coaching Program
REACH Mobile Health ApplicationBEHAVIORAL

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

REACH Mobile Health ApplicationREACH Peer Coaching Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to consent or comply with the study protocol (cognitively impaired adults).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

  • 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.

    PMID: 40548142DERIVED

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, SystemicFatigueMotor Activity

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2024

First Posted

June 28, 2024

Study Start

June 13, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

July 20, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)