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Lupus Intervention for Fatigue Trial (LIFT)

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ClinicalTrials.gov Identifier: NCT02653287
Recruitment Status : Not yet recruiting
First Posted : January 12, 2016
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Rosalind Ramsey-Goldman, Northwestern University

Brief Summary:
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 and group educational sessions focusing on physical activity and nutrition while the control group will receive individual calls in relation to SLE self-management group 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.

Condition or disease Intervention/treatment Phase
Fatigue Physical Activity Lupus Erythematosus, Systemic Behavioral: Experimental Other: Control Not Applicable

Detailed Description:
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 and group educational sessions focusing on physical activity and nutrition while the control group will receive individual calls and group sessions 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lupus Intervention for Fatigue Trial
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
The experimental intervention is a unique combination of four individual counseling sessions based in motivational interviewing and six group educational sessions 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 and group sessions for a caseload of participants. There are no drugs involved in the intervention.
Behavioral: Experimental
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. Participants receive 6 consecutive monthly group sessions, beginning shortly after randomization focusing on the following topics: introduction to physical activity; fruits/vegetables; motivation; lifestyle physical activity; healthy diet; and enhancing your environment. The 1 hour sessions are interactive so participants can share information and support each other.

Active Comparator: Control
The control group intervention will receive six group educational sessions focusing on SLE disease management. A nurse practitioner will be responsible for conducting the group sessions.Control arm participants will also receive four individual phone calls checking in with participants regarding questions about the study or from the group sessions, each lasting approximately 10-15 minutes.
Other: Control
The control group will receive 6 group educational sessions focusing on SLE disease management. Topics include: what is lupus, laboratory tests, medications, taking charge of your health care and managing stress (2 sessions). Sessions will be didactic followed by a brief question and answer period and last about 1 hour. A nurse practitioner will be responsible for conducting the group sessions. Control arm participants receive 4 individual phone calls checking in with participants regarding questions about the study or from the group sessions, each lasting about 10-15 minutes. They occur shortly before first group session, then at 1.5, 3, and 6 months.




Primary Outcome Measures :
  1. Change in Fatigue Severity Scale over time [ Time Frame: Baseline, 3, 6, 12 months ]
    Online questionnaire


Secondary Outcome Measures :
  1. Change in Physical Activity Scale over time [ Time Frame: Baseline, 3, 6, 12 months ]
    Accelerometry

  2. Change in International Physical Activity Questionnaire (IPAQ) over time [ Time Frame: Baseline, 3, 6, 12 months ]
    Phone Interview Questionnaire


Other Outcome Measures:
  1. Change in Nutrition Data Systems for Research (NDSR) over time [ Time Frame: Baseline, 6, 12 months ]
    Dietary Recall Interview



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion criteria:

  • include pregnancy at baseline
  • not meeting inclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653287


Contacts
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Contact: Karen Mancera Cuevas, MS, MPH 312-503-0251 k-mancera-cuevas@northwestern.edu
Contact: Linda Ehrlich-Jones, PhD, RN 312-238-0743 ljones1@ric.org

Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Rosalind Ramsey-Goldman, MD, DrPH Northwestern University

Publications:

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Responsible Party: Rosalind Ramsey-Goldman, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02653287     History of Changes
Other Study ID Numbers: LIFT Study
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It is the intent of all investigators in this project to share any and all resources generated as a result of an award for this project. The final data from this project will be de-identified in accordance with HIPAA guidelines.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rosalind Ramsey-Goldman, Northwestern University:
Fatigue, Physical Activity, Lupus

Additional relevant MeSH terms:
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Fatigue
Lupus Erythematosus, Systemic
Signs and Symptoms
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases