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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the REACH treatment for fatigue in lupus?

The study on web-based education and counseling for lupus patients showed improvements in self-efficacy and fatigue, suggesting that similar digital health interventions like the REACH Mobile Health Application and Peer Coaching Program could be effective in managing fatigue in lupus. ^{1 2 3 4 5}

How is the REACH treatment for fatigue in lupus different from other treatments?

The REACH treatment is unique because it uses a peer coaching program and a mobile health application to provide social support and health education, which can improve self-management and quality of life for lupus patients, especially those from diverse backgrounds. ^{5 6 7 8 9}

Eligibility Criteria

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.

I am 18 years old or older.

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Fatigue, patient reported outcomes, and objective measurement of physical activity in systemic lupus erythematosus. [2022]

3. England 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Determination of the minimal clinically important difference for seven measures of fatigue in Swedish patients with systemic lupus erythematosus. [2022]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Effective Self-Management Interventions for Patients With Lupus: Potential Impact of Peer Mentoring. [2023]

7. England 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. [2022]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Peer-to-Peer Mentoring for African American Women With Lupus: A Feasibility Pilot. [2022]