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

NCT06720584 | Completed

• 2 other identifiers: Pro00111699W81XWH-22-1-0611
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

systemic lupus erythematosus; SLE; Type 2 SLE; health coach; support program; mindfulness; fatigue; brain fog; pain

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Participant Accrual

  Baseline

• Participant Attrition

  10-months post-baseline

Other Outcomes (2)

• Change in LupusPro

  Baseline, 5-months post baseline, and 10-month post-baseline

• Change in Whole Health Assessment

  Baseline, 5-months post baseline, and 10-month post-baseline

Study Arms (2)

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.

Behavioral: Health coach-led, online support program for people living with lupus

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.

Behavioral: Health coach-led, online support program for people living with lupus

Interventions

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.

Group 1: Immediate Treatment; Group 2: Wait-List Control (Delayed Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Duke University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Fatigue; Mental Fatigue; Pain

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Neurologic Manifestations

Study Officials

• Jennifer Rogers, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot randomized wait-list controlled trial

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: December 6, 2024
• Study Start: March 7, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)