REACH Program for Fatigue in Lupus

(REACH Trial)

Overseen By Shanthini Kasturi, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts Medical Center

Disqualifiers: Cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called REACH, designed to reduce fatigue in people with lupus, an autoimmune disease causing tiredness and joint pain. Researchers aim to determine if talking to a peer coach and using a mobile app can help manage this fatigue. Participants will be divided into two groups: one will use both the app and have weekly meetings with a coach, while the other will use the app only. Individuals diagnosed with lupus, experiencing significant fatigue, possessing a smartphone, and having a doctor’s approval for physical activity might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to explore new ways to manage lupus fatigue.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor before participating.

What prior data suggests that the REACH program is safe for people with lupus?

Research has shown that digital health programs, such as the REACH program, are generally safe and easy to use. In a previous study, similar online education and counseling programs for people with lupus improved fatigue management and self-confidence without major safety issues.

The REACH program combines a mobile app with peer support to help people with lupus manage fatigue. Studies of similar mobile health programs have not reported serious side effects. Participants typically find them helpful and simple to use.

Since the REACH program does not involve medication, it avoids the risks of drug side effects. It focuses on setting movement goals and tracking progress, providing a safe way to manage fatigue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The REACH Program for Fatigue in Lupus is unique because it brings a fresh approach to managing fatigue, a common challenge for lupus patients. Unlike traditional treatments, which may include medication or lifestyle changes, the REACH Program leverages digital health technology and peer coaching. Participants get access to a mobile health app designed to help them manage their condition more effectively, along with weekly sessions with a peer coach who offers support and guidance. This combination of technology and personal interaction offers a potentially more engaging and personalized way to combat fatigue in lupus, which is why researchers are excited about its potential impact.

What evidence suggests that the REACH program is effective for reducing fatigue in lupus?

Research shows that the REACH peer coaching program, a treatment arm in this trial, may help reduce tiredness in people with systemic lupus erythematosus (SLE). Early results suggest that this program, which combines mobile health tools with peer coaching, can help participants manage their energy more effectively. Previous studies found that participants felt less fatigued and could accomplish more in their daily lives. This trial will compare the effectiveness of the REACH peer coaching program to another arm using only the mobile health app. Early results indicate that adding peer coaching might provide additional benefits. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Ownership of a smartphone

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

Physician's permission to participate in the study (including engagement in physical activity)

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the REACH peer coaching program or use the REACH mobile health application for 12 weeks

12 weeks

Weekly meetings with peer coach and weekly symptom surveys

Follow-up

Participants complete study surveys and provide feedback 12 weeks after the program ends

12 weeks

Long-term follow-up

Participants' adherence and fatigue levels are monitored up to 24 weeks

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• REACH

Trial Overview 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.

How Is the Trial Designed?

Group I: REACH Peer Coaching Program Experimental Treatment 2 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 Application Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

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

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

In a study of 51 Swedish patients with systemic lupus erythematosus (SLE), seven different fatigue questionnaires were evaluated to determine the minimal clinically important difference (MCID) for measuring fatigue, with estimates ranging from 4.3 to 17.0 depending on the method used.

While all seven questionnaires were effective in detecting MCIDs for fatigue, the Numeric Rating Scale (NRS) was less favored by respondents and provided the least favorable estimates, suggesting it may not be the best tool for assessing fatigue in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of the minimal clinically important difference for seven measures of fatigue in Swedish patients with systemic lupus erythematosus. Pettersson, S., Lundberg, IE., Liang, MH., et al.[2022]

The ALPHA Project identified key barriers in lupus care and treatment through expert interviews and a global survey, categorizing them into drug development, clinical care, and access to care.

Top recommended solutions included simplifying outcome measures and defining the lupus spectrum, with leveraging social media receiving the highest feasibility score, highlighting the importance of digital technology in improving lupus management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ALPHA Project: Establishing consensus and prioritisation of global community recommendations to address major challenges in lupus diagnosis, care, treatment and research. Tse, K., Sangodkar, S., Bloch, L., et al.[2021]

African Americans have a significantly higher prevalence of systemic lupus erythematosus (SLE) compared to whites, experiencing more severe disease outcomes and earlier onset.

Peer mentoring is proposed as an effective intervention for African American women with SLE, leveraging the shared experiences of successful peers to improve trust and communication in healthcare, potentially reducing disparities in outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Self-Management Interventions for Patients With Lupus: Potential Impact of Peer Mentoring. Williams, EM., Egede, L., Faith, T., et al.[2023]

This study aims to evaluate a peer mentorship program specifically designed for African American women with systemic lupus erythematosus (SLE), which has shown promise in improving self-management and health-related quality of life based on preliminary data.

The intervention is innovative as it targets a demographic disproportionately affected by SLE, and it could serve as a model for future programs aimed at reducing health disparities in chronic illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer approaches to self-management (PALS): comparing a peer mentoring approach for disease self-management in African American women with lupus with a social support control: study protocol for a randomized controlled trial. Williams, EM., Egede, L., Oates, JC., et al.[2022]

The LT-PALS program effectively increased knowledge and intentions to participate in lupus clinical trials among participants, particularly benefiting those from underrepresented groups, with 46.9% of participants engaging in a trial within a year.

Participants who received peer-to-peer education reported higher self-efficacy and satisfaction with the program, especially among Black and Hispanic individuals, indicating the program's potential to improve diversity in clinical trial representation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Utility of a Pilot Peer Education Program to Improve Patient Engagement in Lupus Clinical Trials: Implementation and Evaluation in a Multisite Model Within a Lupus Clinical Trials Network. Sheikh, SZ., Donovan, C., Menezes, C., et al.[2023]

The peer mentoring program for individuals with systemic lupus erythematosus (SLE) showed promising results, with mentees experiencing trends toward lower disease activity and improved health-related quality of life, including reduced anxiety and depression over a 12-week period.

Participants reported high satisfaction with the peer mentoring intervention, indicating that this approach is feasible and may enhance self-management and overall care for African American women with SLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-to-Peer Mentoring for African American Women With Lupus: A Feasibility Pilot. Williams, EM., Hyer, JM., Viswanathan, R., et al.[2022]

In a study of 123 adults with systemic lupus erythematosus (SLE), increased time spent in moderate to vigorous physical activity was linked to lower levels of fatigue, as measured by the Fatigue Severity Scale and PROMIS instruments.

The study found that SLE patients reported worse health status across multiple domains compared to the general population, highlighting the potential benefits of physical activity in improving fatigue and overall health in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue, patient reported outcomes, and objective measurement of physical activity in systemic lupus erythematosus. Mahieu, MA., Ahn, GE., Chmiel, JS., et al.[2022]

In a study of 515 systemic lupus erythematosus (SLE) patients, factors such as Caucasian ethnicity, pain levels, abnormal illness-related behaviors, and feelings of helplessness were linked to increased fatigue, highlighting the importance of psychological and social factors in managing fatigue.

Interestingly, traditional SLE-specific measures like disease activity and damage did not correlate with fatigue levels, suggesting that interventions to reduce fatigue should focus on addressing pain and psychological well-being rather than just disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease activity and damage are not associated with increased levels of fatigue in systemic lupus erythematosus patients from a multiethnic cohort: LXVII. Burgos, PI., Alarcón, GS., McGwin, G., et al.[2022]

A randomized controlled trial involving 80 patients with systemic lupus erythematosus showed that web-based education and counseling significantly improved self-efficacy, fatigue levels, and satisfaction with chronic illness care in the experimental group after six months.

The study highlights the potential of web-based interventions to enhance patient outcomes, suggesting that similar approaches could be beneficial for other patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of web-based education and counselling for patients with systemic lupus erythematosus: self-efficacy, fatigue and assessment of care. Kankaya, H., Karadakovan, A.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40548142/

an mHealth-enabled peer coaching intervention for fatigue ... This study will pilot test the feasibility and effectiveness of the REACH peer coaching intervention, a behavioral theory-based program leveraging mHealth ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06479213

REACH (Restore Energy, Activity Can Help) Lupus Study ... Researchers will compare the REACH peer coaching program to the REACH mobile health application to see if the REACH program works to reduce fatigue.

3. acrabstracts.org acrabstracts.org/abstract/mhealth-enabled-peer-coaching-for-fatigue-in-systemic-lupus-erythematosus-sle-preliminary-results-from-the-restore-energy-activity-can-help-reach-pilot-randomized-controlled-trial/

mHealth-enabled Peer Coaching for Fatigue in Systemic ... Conclusion: The REACH peer coaching intervention was feasible and demonstrated promising preliminary efficacy for reducing fatigue in SLE. Participants in the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000821

an mHealth-enabled peer coaching intervention for fatigue ... This study will pilot test the feasibility and effectiveness of the REACH peer coaching intervention, a behavioral theory-based program leveraging mHealth ...

5. withpower.com withpower.com/trial/phase-fatigue-5-2024-3c1b3

REACH Program for Fatigue in Lupus · Info for Participants The study on web-based education and counseling for lupus patients showed improvements in self-efficacy and fatigue, suggesting that similar digital health ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12178804/

an mHealth-enabled peer coaching intervention for fatigue in ... This study will pilot test the feasibility and effectiveness of the REACH peer coaching intervention, a behavioral theory-based program leveraging mHealth ...

7. tuftsmedicine.org tuftsmedicine.org/research-clinical-trials/find-clinical-trials/reach-lupus-study

REACH Lupus Study REACH is a program to energize and empower people living with lupus through movement. The REACH Lupus study is a randomized controlled pilot study to evaluate ...