Systemic Lupus ErythematosusREACHNCT06479213
REACH (Restore Energy, Activity Can Help) Lupus Study
A study testing REACH Peer Coaching Program and REACH Mobile Health Application in people with Systemic Lupus Erythematosus and Fatigue, run by Tufts Medical Center at 1 site in United States.
Trial 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: 1. Is the REACH program feasible and acceptable to participants? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Fatigue
- What is being tested?
- REACH Peer Coaching Program and REACH Mobile Health Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to consent or comply with the study protocol (cognitively impaired adults).
Trial locations and contacts
1 site in 1 country.
About this 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:
- Is the REACH program feasible and acceptable to participants?
- What is the impact of the REACH program on fatigue?
Read more
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
- Conditions
- Systemic Lupus Erythematosus, Fatigue
- Being tested
- REACH Peer Coaching Program, REACH Mobile Health Application
- Keywords
- Physical activity, Peer coaching, Mobile health application, Chronic disease self-management
- Medical subject headings
- Lupus Erythematosus, Systemic, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REACH Peer Coaching ProgramBehavioural
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 ApplicationBehavioural
Participants will use the the REACH mobile health application to set weekly movement goals and log physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: REACH Peer Coaching Program; Behavioral: 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. Receives: Behavioral: REACH Mobile Health Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Enrollment rates (subjects enrolled/eligible individuals approached).
Measured: 6 months
Adherence
Proportions of educational modules, activity logs, and coaching sessions completed.
Measured: 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.
Measured: 12 to 24 weeks
Secondary outcomes (1)
Fatigue
Effect size estimate of change in fatigue using the Fatigue Severity Scale
Measured: 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start13 Jun 2024
- Primary completionSep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479213
- Sponsor's protocol ID
- 00004759
- Other IDs
- K23AR078177
- Acronym
- REACH
- Status last verified
- Apr 2025
- First submitted
- 18 Jun 2024
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40548142
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REACH (Restore Energy, Activity Can Help) Lupus Study
- ClinicalTrials.gov ID
- NCT06479213
- Acronym / sponsor ID
- REACH / 00004759
- Conditions
- Systemic Lupus Erythematosus, Fatigue
- Keywords
- Physical activity, Peer coaching, Mobile health application, Chronic disease self-management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the REACH program feasible and acceptable to participants?
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REACH Peer Coaching Program | Experimental | Behavioral: REACH Peer Coaching Program, Behavioral: REACH Mobile Health ApplicationParticipants 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. |
| REACH Mobile Health Application | Active comparator | Behavioral: REACH Mobile Health ApplicationParticipants will receive access to the REACH mobile health application which they will use during the 12 weeks of the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Inability to consent or comply with the study protocol (cognitively impaired adults).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REACH Peer Coaching ProgramThe 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. | Behavioural | REACH Peer Coaching Program |
| REACH Mobile Health ApplicationParticipants will use the the REACH mobile health application to set weekly movement goals and log physical activity. | Behavioural | REACH Mobile Health Application, REACH Peer Coaching Program |
Primary outcome
Feasibility
Time frame: 6 months
Enrollment rates (subjects enrolled/eligible individuals approached).
Adherence
Time frame: 12 months
Proportions of educational modules, activity logs, and coaching sessions completed.
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.
1 secondary outcome
Fatigue
Time frame: 12 weeks and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Derived from this study: PubMed 40548142Gulati 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.
- Study Landing PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REACH Peer Coaching Program and REACH Mobile Health Application in people with Systemic Lupus Erythematosus and Fatigue, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06479213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.