CompletedNot Applicable

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

United States36 participantsStarted 2025-03-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria. (1) enrolled in the Duke Lupus Registry\* for ≥1 year; (2) had ≥ 3 visits in the Duke Lupus Registry, (3) attended a Duke Lupus clinic visit in the last year, (4) meets Type 1 \& 2 SLE Activity criteria as defined below, (5) meets Persistent Type 2 SLE or Intermittent Type 2 SLE criteria as described below, (meets classification criteria for SLE (SLICC, ACR, or EULAR/ACR)), (7) female. * Active Type 1: SLEDAI ≥6, clinical SLEDAI ≥4, Type 1 PGA ≥1, or active lupus nephritis * Active Type 2: PSD: ≥8 or Type 2 PGA ≥1 * Persistent Type 2 SLE: Active Type 2 SLE at 3 visits, Active Type 1 SLE at 0-2 visits * Intermittent Type 2 SLE: Active Type 2 SLE at 1-2 with Active Type 1 SLE at 1-3 visits Participants will be stratified based on their Type 2 SLE activity in the prior 3 Duke Lupus Clinic visits as defined above. \* Duke Lupus Registry participants must be age ≥18 years; disease duration of ≥1 year; ability to speak and read English; able to consent themselves 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Participant Satisfaction

Timeframe: Post-intervention (within four weeks of intervention ending)

Intervention Adherence

Timeframe: 10-months post-baseline

Survey Completion

Timeframe: 10-months post-baseline

Trial details

NCT IDNCT06720584

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Systemic Lupus Erythematosus (SLE) trials