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Behavioral Intervention

REACH Program for Fatigue in Lupus (REACH Trial)

N/A

Recruiting

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of systemic lupus erythematosus based on 2019 American College of Rheumatology classification criteria

Age ≥ 18 years

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a peer coaching program called REACH for fatigue in people with lupus. They want to know if the program is feasible and if it helps reduce fatigue. Participants will use a

Who is the study for?

This trial is for individuals with systemic lupus erythematosus who experience fatigue. Participants will use a mobile app to track physical activity and may also receive peer coaching. They must be willing to complete surveys and provide feedback on the program.

What is being tested?

The REACH clinical trial is testing whether a peer coaching program can reduce fatigue in people with lupus compared to just using a mobile health application. It involves setting movement goals, logging activities, and regular check-ins.

What are the potential side effects?

Since this study focuses on non-medical interventions like peer coaching and mobile app usage, traditional side effects associated with medications are not expected. However, participants might experience discomfort or stress from lifestyle changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with lupus according to the 2019 criteria.

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I am 18 years old or older.

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I often feel very tired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able to understand and follow the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability

Adherence

Feasibility

Secondary study objectives

Fatigue

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: REACH Peer Coaching ProgramExperimental Treatment2 Interventions

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 II: REACH Mobile Health ApplicationActive Control1 Intervention

Participants will receive access to the REACH mobile health application which they will use during the 12 weeks of the program.

0 / 4Eligibility criteria met