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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effectiveness of the iCHART (integrated Care to Help At-Risk Teens) intervention for adolescents aged 12 to 18 who are experiencing depression or suicidal behavior. This study aims to reduce suicide-related events by comparing iCHART to usual treatment in a randomized controlled trial including 900 participants. The study also examines factors that affect treatment response and uses implementation science to assess barriers, facilitators, and outcomes like acceptability and feasibility to support health equity. iCHART combines three main parts: a Safety Planning App that helps providers deliver care through an app instead of paper, a Mental Health Screener questionnaire to personalize treatment plans, and a series of text messages over 2 to 3 weeks to encourage engagement with safety plans and treatment. Participants are randomly assigned to either receive iCHART or treatment as usual, which may include a paper safety plan and standard care from their providers. Participants will be actively involved through mental health assessments at baseline and follow-up points up to 12 months, including evaluations of depression severity and suicidal thoughts and behaviors. The study also tracks service use, app usage, and participants' views on the intervention's acceptability, usability, feasibility, and appropriateness. This comprehensive monitoring helps understand how well iCHART works and informs future use in pediatric care settings.
Actively Recruiting
Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.