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Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

Study acronym: cSLE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment target: 196 to 175
    • Eligibility criteria expanded, about 15 words
    • Site contacts updated at 2 of 7 sites
    v4
  2. Site details revised at 7 of 7 sitesv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2024 to Sep 12, 2024
    • Study sites: 0 to 7
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study aims to investigate the feasibility and effectiveness of a cognitive behavioral coping skills program, Treatment and Education Approach for Childhood-onset Lupus (TEACH), for youth with cSLE when integrated into medical care. This TEACH program aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.
Trial Details
NCT Number NCT06232304
Lead Sponsor Michigan State University
Collaborators: United States Department of Defense, The Hospital for Sick Children, Seattle Children's Hospital, Children's Hospital Medical Center, Cincinnati, Tulane University, University of Alabama at Birmingham, Helen DeVos Children's Hospital, Montefiore Medical Center
Conditions
(from sponsor)		 Systemic Lupus Erythematosus of Childhood (Disorder)
Related terms Depression, Fatigue, Pain, Rheumatic Diseases
Enrollment 175 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov