Whole Health Empowerment for Endotypes of Lupus: Improving Quality of Life in SLE (WHEEL)
WHEEL: Improving Quality of Life in SLE by Stratified Personalized Health Planning
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Eight, virtual, bi-weekly group sessions, ~ 60-90 minutes per session
- Program facilitated by a certified health coach with clinical licensure and supported by a co-facilitator
- Themed group sessions focusing on understanding disease, medications and symptoms, motion/exercise, sleep/rest, nutrition, mindfulness/stress management, and personal goals.
- 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.
- Each group session includes interactive activities, health coaching, goal progress tracking, mindfulness-based practices, group discussion, social support, and empathy and empowerment between patients
- 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)
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1: Immediate Treatment
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.
|
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. |
|
Other: Group 2: Wait-List Control (Delayed Intervention)
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Adherence
Time Frame: 10-months post-baseline
|
Total number of group sessions and health coach sessions attended.
|
10-months post-baseline
|
|
Survey Completion
Time Frame: 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. |
10-months post-baseline
|
|
Participant Satisfaction
Time Frame: 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
|
Post-intervention (within four weeks of intervention ending)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Accrual
Time Frame: Baseline
|
Number of participants consented to the study.
|
Baseline
|
|
Participant Attrition
Time Frame: 10-months post-baseline
|
Number of consented participants who withdrew/were withdrawn from the program.
|
10-months post-baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in LupusPro
Time Frame: Baseline, 5-months post baseline, and 10-month post-baseline
|
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
|
|
Change in Whole Health Assessment
Time Frame: Baseline, 5-months post baseline, and 10-month post-baseline
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Rogers, MD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00111699
- W81XWH-22-1-0611 (Other Grant/Funding Number: Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.