REACH Program for Fatigue in Lupus
(REACH Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Tufts Medical Center
Disqualifiers: Cognitive impairment
No Placebo Group
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.
12345How 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.
56789Eligibility 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.
+3 more
Exclusion Criteria
I am able to understand and follow the study's requirements.
Trial 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
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tufts Medical CenterBoston, MA
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Who Is Running the Clinical Trial?
Tufts Medical CenterLead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Collaborator
References
Disease activity and damage are not associated with increased levels of fatigue in systemic lupus erythematosus patients from a multiethnic cohort: LXVII. [2022]To determine the factors associated with increased levels of fatigue over the course of the disease in systemic lupus erythematosus (SLE) patients from LUpus in MInorities: NAture versus nurture, a longitudinal multiethnic cohort.
Fatigue, patient reported outcomes, and objective measurement of physical activity in systemic lupus erythematosus. [2022]Fatigue is a common symptom in systemic lupus erythematosus (SLE), and engaging in physical activity may reduce fatigue. We aimed to characterize relationships between fatigue, other health status measures assessed with the Patient Reported Outcomes Measurement Information System (PROMIS) instruments, and accelerometer-based physical activity measurements in patients with SLE. The internal consistency of each PROMIS measure in our SLE sample was also evaluated.
Effects of web-based education and counselling for patients with systemic lupus erythematosus: self-efficacy, fatigue and assessment of care. [2021]The aim of this study was to determine the effect of web-based education and counselling for patients with systemic lupus erythematosus on self-efficacy, fatigue and assessment of care.
Determination of the minimal clinically important difference for seven measures of fatigue in Swedish patients with systemic lupus erythematosus. [2022]To estimate the minimal clinically important difference (MCID) in seven self-administered measures assessing fatigue in Swedish patients with systemic lupus erythematosus (SLE).
The ALPHA Project: Establishing consensus and prioritisation of global community recommendations to address major challenges in lupus diagnosis, care, treatment and research. [2021]The Addressing Lupus Pillars for Health Advancement (ALPHA) Project is a global consensus effort to identify, prioritise and address top barriers in lupus impacting diagnosis, care, treatment and research. To conduct this process, the ALPHA Project convened a multistakeholder Global Advisory Committee (GAC) of lupus experts and collected input from global audiences, including patients. In phase I, the ALPHA Project used expert interviews and a global survey of lupus experts to identify and categorise barriers into three overarching pillars: drug development, clinical care and access to care. In phase II, reported here, the GAC developed recommended actionable solutions to address these previously identified barriers through an in-person stakeholder meeting, followed by a two-round scoring process. Recommendations were assessed for feasibility, impact and timeline for implementation (FIT), where potential FIT component values were between 1 and 3 and total scores were between 3 and 9. Higher scores represented higher achievability based on the composite of the three criteria. Simplifying and standardising outcomes measures, including steroid sparing as an outcome (drug development) and defining the lupus spectrum (clinical care) ranked as the highest two priority solutions during the GAC meeting and received high FIT scores (7.67 and 7.44, respectively). Leveraging social media (access to care) received the highest FIT score across all pillars (7.86). Cross-cutting themes of many solutions include leveraging digital technology and applying specific considerations for special populations, including paediatrics. Implementing the recommendations to address key barriers to drug development, clinical care and access to care is essential to improving the quality of life of adults and children with lupus. Multistakeholder collaboration and guidance across existing efforts globally is warranted.
Effective Self-Management Interventions for Patients With Lupus: Potential Impact of Peer Mentoring. [2023]Systemic lupus erythematosus (SLE) is associated with significant mortality, morbidity and cost for the individual patient and society. In the United States, African Americans (AAs) have 3-4 times greater prevalence of lupus, risk of developing lupus at an earlier age and lupus-related disease activity, organ damage and mortality compared with whites. Evidence-based self-management interventions that incorporate both social support and health education have reduced pain, improved function and delayed disability among patients with lupus. However, AAs and women are still disproportionately affected by lupus. This article presents the argument that peer mentoring may be an especially effective intervention approach for AA women with SLE. SLE peers with a track record of success in lupus management and have a personal perspective that clinicians often lack. This commonality and credibility can establish trust, increase communication and, in turn, decrease disparities in healthcare outcomes.
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]Systemic lupus erythematosus (SLE or lupus) is a chronic autoimmune disease that is associated with increased morbidity, mortality, healthcare costs and decreased quality of life. African Americans in the USA have three to four times greater prevalence of SLE, risk of developing SLE at an earlier age, and SLE-related disease activity, damage, and mortality compared with Caucasians, with the highest rates experienced by African American women. There is strong evidence that patient-level factors are associated with outcomes, which justifies targeting them with intervention. While evidence-based self-management interventions that incorporate both social support and health education have reduced pain, improved function, and delayed disability among patients with SLE, African Americans and women are still disproportionately impacted by SLE. Peer mentoring interventions are effective in other chronic conditions that disproportionately affect minorities, such as diabetes mellitus, HIV, and kidney disease, but there is currently no empirically tested peer mentoring intervention developed for patients with SLE. Preliminary data from our group suggest that peer mentoring improves self-management, reduces disease activity, and improves health-related quality of life (HRQOL) in African American women with SLE.
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]To assess outcomes related to Lupus Therapeutics' Patient Advocates for Lupus Studies (LT-PALS), a peer-to-peer lupus clinical trial (LCT) education program designed to improve representation of diverse groups in LCTs. Patients with lupus and clinical trial participation experience were trained as peer educators (PALs) providing trial-agnostic education to trial-naive patients with lupus.
Peer-to-Peer Mentoring for African American Women With Lupus: A Feasibility Pilot. [2022]To examine the feasibility and potential benefits of peer mentoring to improve the disease self-management and quality of life of individuals with systemic lupus erythematosus (SLE).