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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-22-1-0611 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Immediate Treatment | Experimental | Group 1 participants receive the intervention first which is completing the 4-month program. They will receive an additional survey when Group 2 completes the intervention. |
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| Group 2: Wait-List Control (Delayed Intervention) | Other | Group 2: Wait-List Control (Delayed Intervention) does not get the intervention while Group 1 is getting the intervention. Group 2 receives the intervention AFTER Group 1 has completed the intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health coach-led, online support program for people living with lupus | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction | o Study-specific survey asking participants about their satisfaction on a scale from 0=completely unsatisfied to 10=completely satisfied | Post-intervention (within four weeks of intervention ending) |
| Intervention Adherence | Total number of group sessions and health coach sessions attended. | 10-months post-baseline |
| Survey Completion | 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. | 10-months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Accrual | Number of participants consented to the study. | Baseline |
| Participant Attrition | Number of consented participants who withdrew/were withdrawn from the program. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LupusPro | LupusPro is a 43-question quality of life survey designed specifically for patients with lupus. It measures ways that lupus may affect a patient's mental, emotional and physical health. Scores range from 0 -100 and higher scores indicate higher quality of life. | Baseline, 5-months post baseline, and 10-month post-baseline |
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Rogers, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2025 | Oct 24, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D005221 | Fatigue |
| D005222 | Mental Fatigue |
| D010146 | Pain |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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Pilot randomized wait-list controlled trial
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| 10-months post-baseline |
| Change in Whole Health Assessment |
Whole Health Assessment assesses 10 components of everyday life that can affect their overall health. Scores range from 0 -100 and higher scores indicate areas of strength. |
| Baseline, 5-months post baseline, and 10-month post-baseline |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |