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

Not Applicable

Active, not recruiting

• Conditions: Systemic Lupus Erythematosus (SLE)

• Registration Number: NCT06720584
• Lead Sponsor: Duke University

Brief 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).

Study Timeline

• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-06
• Status Verified: 2025-03
• Study Start: 2025-03-07
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

(1) significant cognitive impairment as determined by the treating rheumatologist; (2) untreated serious mental illness; (3) inability to provide informed consent; (4) participation in Aim 2 WHEEL curriculum development; (5) does not commit to attending sessions and using a tablet/computer. All participants will provide e-consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Participant Satisfaction	Post-intervention (within four weeks of intervention ending)	o Study-specific survey asking participants about their satisfaction on a scale from 0=completely unsatisfied to 10=completely satisfied
Intervention Adherence	10-months post-baseline	Total number of group sessions and health coach sessions attended.
Survey Completion	10-months post-baseline	Count the total number of surveys completed at 10 months post-baseline. Participants are to complete 2 surveys, LupusPRO and Whole Health Assessments pre-intervention, and 2 surveys, LupusPRO and Whole Health Assessments post-intervention.; The range of completed surveys is 0-4 surveys, 0-100% complete. Completion of the entire survey is counted as completed.

Secondary Outcome Measures

Name	Time	Method
Participant Accrual	Baseline	Number of participants consented to the study.
Participant Attrition	10-months post-baseline	Number of consented participants who withdrew/were withdrawn from the program.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States