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Multi-site Feasibility Trial of WHEEL, Whole Health for Lupus

Award Number: R01AT013961
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/17/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2029

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Multi-site Feasibility Trial of WHEEL, Whole Health for Lupus - ABSTRACT Pain and fatigue are debilitating symptoms that substantially impair qualitative of life for individuals living with systemic lupus erythematosus (SLE), the prototypical autoimmune disease. These pervasive symptoms, collectively termed Type 2 SLE, often persist despite advances in immunosuppressive treatment and may best be managed through integrated, mind-body approaches to care. The Whole Health Empowerment for Lupus (WHEEL) program, a 12- week a SLE-specific holistic intervention delivered by health coaches and augmented by small group peer support was designed to target these unmet needs. WHEEL has demonstrated strong feasibility, acceptability, fidelity and improvement across multiple whole health domains. The overarching goal of this feasibility study is to prepare for a successful multi-site randomized controlled efficacy trial of the WHEEL intervention. We hypothesize that patients living with lupus can improve their QoL by learning the mindfulness and coping skills and applying mindfulness body practices through the training and curriculum provided in the WHEEL program. We propose a randomized controlled trial comparing the WHEEL intervention to standard of care therapy in 64 adult SLE patients with on-going pain and fatigue. Participants will be recruited from Duke University and Rush University. The WHEEL intervention will be delivered virtually through 12 weekly sessions including 9 small- group sessions and 3 individual health coach sessions. Aim 1 of the study will determine multi-site infrastructure feasibility through regulatory approvals, training completion, fidelity to mock sessions, and pilot testing of data collection. Aim 2 will evaluate feasibility, demand, acceptability, and fidelity of the intervention. Feasibility will be defined as by 80% completion of outcome measures. Demand by will be determined by achieving ≥80% of our target enrollment of n=64 participants and ≥80% participants attending at least 50% of intervention sessions. Acceptability will be demonstrated by ≥80% of participant satisfaction and fidelity by independent review of session recordings using standardized checklist. In-depth semi-structured qualitative interviews will complement quantitative metrics to provide a rich assessment of program components, feasibility and acceptability. Findings from this study will inform the design and implementation of a multi-site efficacy trial to enhance scalability and evaluate the impact of a whole health, integrated strategy on pain, fatigue and quality of life for individuals living with SLE.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $1,698,570 )
2026	2026	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	000	1	9/17/2026	NEW	$1,698,570
														Subtotal = $1,698,570

Grand Total All Awards = $1,698,570

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Multi-site Feasibility Trial of WHEEL, Whole Health for Lupus

Award Number: R01AT013961

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/17/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2029

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