Lupus Intervention for Fatigue Trial

Study Overview
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Brief Summary
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Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (SLE). The intervention group will receive individual coaching sessions focusing on physical activity and nutrition while the control group will receive individual calls in relation to SLE self-management educational sessions.This study is designed to evaluate the LIFT intervention to decrease fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with SLE.

Detailed Description
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Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (SLE). The intervention group will receive individual coaching based in motivational interviewing sessions focusing on physical activity and nutrition while the control group will receive individual calls focusing on SLE self-management. This study is designed to evaluate the LIFT intervention to decreased fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with SLE.

Official Title
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Lupus Intervention for Fatigue Trial

Conditions
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Fatigue, Physical Activity, Lupus Erythematosus, Systemic

Intervention / Treatment
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* Behavioral: Experimental
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: include meeting at least 4 of 11 American College of Rheumatology (ACR) classification criteria for definite SLE, or 3 out of 11 ACR classification criteria with also meeting at least one SLICC criteria be at least 18 years of age have a BMI between 18-40 kg/m2 be able to ambulate at least household distances (50ft) be able to provide informed consent. be able to speak and read English Exclusion criteria: include pregnancy at baseline not meeting inclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The experimental intervention is a unique combination of four individual counseling sessions based in motivational interviewing focusing on physical activity, dietary behavior and behavioral strategies. The individual sessions will provide a tailored personalized intervention including problem-solving and goal setting for increasing physical activity, and following a healthy diet. Healthy Lifestyle Coaches (RN or MPH) will be responsible for conducting the individual for a caseload of participants. There are no drugs involved in the intervention. | Behavioral: Experimental<br>* The experimental intervention includes 4 individual coaching sessions (initial 1 hour in-person and remaining 10-15 minutes per telephone) designed to identify barriers and supports for physical activity and nutrition using motivational interviewing. They occur shortly after randomization, 1.5, 3, and 6 months. Daily participants monitor their physical activity via the Fitbit Flex and their dietary behavior on a paper diary.<br>|
| Active Comparator: Control<br>The control group intervention will receive four individual phone calls checking in with participants regarding questions about the study or from the educational sessions focusing on SLE disease management, each lasting approximately 10-15 minutes. | Other: Control<br>* The control group will receive four individual phone calls focusing on education for SLE disease management, as well as answering any questions the participants have about the study. Topics include: what is lupus, laboratory tests, medications, taking charge of your health care and managing stress (2 sessions). Each call will last about 10-15 minutes, and occur shortly after randomization, then at 1.5, 3, and 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fatigue Severity Scale over time | Online questionnaire | Baseline, 3, 6, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Activity Scale over time | Accelerometry | Baseline, 3, 6, 12 months | 
| Change in International Physical Activity Questionnaire (IPAQ) over time | Phone Interview Questionnaire | Baseline, 3, 6, 12 months | 
| Godin Leisure Time Exercise Questionnaire | Phone Interview Questionnaire | Baseline, 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Physical Activity, Lupus