NCT06720584

Whole Health Empowerment for Endotypes of Lupus: Improving Quality of Life in SLE

WHEEL: Improving Quality of Life in SLE by Stratified Personalized Health Planning

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For people living with people living with systemic lupus erythematosus (SLE) the symptoms with the largest impact on their quality of life - fatigue, pain, and brain fog - are not always addressed in rheumatology clinic visits. To address the quality-of-life limitations, the investigators have created and will test the health coach-led, 8-session Whole Health Empowerment for Endotypes of Lupus (WHEEL) online support program. This program moves beyond traditional clinic visits and standard educational curricula to engage patients in creating their own health goals and therapeutic plans in a setting that emphasizes both the psychosocial and clinical factors contributing to disease. Participants will attend the virtual sessions, work with their health coach on two additional sessions, and complete surveys.

Detailed description

The investigators have created the WHEEL Program\* (explained below) based on a previously developed Personalized Health Planning model, patient surveys, patient and provider focus groups feedback for WHEEL curricula and materials, and a User Testing of the WHEEL Program. The objective is to assess the feasibility of the WHEEL program, including its acceptability, demand, implementation, practicality, integration, and preliminary efficacy as an approach to improve quality of life in people with SLE. Our working hypothesis is that the WHEEL protocol will be feasible and acceptable to patients with SLE and demonstrate initial efficacy for improving quality of life. The investigators expect, however, that patients with Intermittent and Persistent Type 2 SLE\* (see description below) will experience improvement in different domains of quality of life based on their initial deficits and the content of each program. At the completion of this proposal, the investigators will have a tested, feasible, and expandable protocol that the investigators will be prepared to test in larger SLE populations. This work represents a dramatic breakthrough for SLE self-management programs, tailoring the program to the specific SLE endotypes, providing essential group support, and empower patients with SLE to take control of their disease to improve their quality of life. WHEEL Program Key Elements: 1. Eight, virtual, bi-weekly group sessions, \~ 60-90 minutes per session 2. Program facilitated by a certified health coach with clinical licensure and supported by a co-facilitator 3. Themed group sessions focusing on understanding disease, medications and symptoms, motion/exercise, sleep/rest, nutrition, mindfulness/stress management, and personal goals. 4. Curriculum comprised into a patient notebook with interactive and educational content, activities, and figures that mirror the information and activities that comprise the group sessions. 5. Each group session includes interactive activities, health coaching, goal progress tracking, mindfulness-based practices, group discussion, social support, and empathy and empowerment between patients 6. One-on-one consultation with health coach to develop a Personal Health Plan supported by shared patient-provider health assessments (i.e., Patient Health Self-Assessment and Provider Health Risk Assessment) 7. Follow-up one-on-one consultation with the health coach to enhance engagement through motivational coaching based on patient-identified priorities and health goals. Description of Type 1 and 2 SLE symptoms, Intermittent and Persistent Type 2 SLE: A team of clinicians and investigators within the Duke Lupus Clinic developed a new approach to SLE care by creating the Type 1 \& 2 SLE Model. In this model, signs and symptoms of SLE are divided into two broad categories. Type 1 SLE symptoms consist of what is classically considered SLE activity and recorded in provider-reported measures of SLE activity, including synovitis, cutaneous lupus, nephritis, and other objective signs. Type 2 SLE symptoms include fatigue, myalgia, mood disturbance, and cognitive dysfunction. Duke researchers further refined the model and propose two endotypes of SLE: Intermittent Type 2 SLE (correlation between Type 1 \& 2 SLE symptoms, with both sets of symptoms worsening and improving around the same time) and Persistent Type 2 SLE (omnipresent Type 2 SLE symptoms that do not fluctuate when they have flares of Type 1 SLE).

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

Type	Name	Description
BEHAVIORAL	Health coach-led, online support program for people living with lupus	The health coach-led online support and education program for people living with lupus. It includes 8 group sessions and 2 individual sessions with the health coach to set individual goals. Each program group will include up to 10 participants. Program Session Structure (\~60-75 minutes): educational component presented using a slide set, discussion questions interspersed, mindfulness activities, goal check-ins. Associated Materials: Notebook, expert videos available.

Timeline

• Start date: 2025-03-07
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-12-06
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States