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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating whether adding a standardized cognitive self-management program called Thinking Skills for Work-Cognitive Self-Management Strategies CSM to usual Supported Employment and Education SEE services improves work and school outcomes for young adults experiencing first episode psychosis FEP. This pilot cluster randomized trial involves six Coordinated Specialty Care CSC programs in diverse geographic areas serving various populations. The study aims to determine if the CSM program enhances participants ability to find or keep jobs or stay in school, as well as improve cognition and confidence in managing cognitive challenges. Participants are assigned by site to either the experimental group receiving the 12-session CSM program alongside regular SEE services or the control group receiving SEE services alone. The CSM program includes weekly sessions lasting 45-60 minutes, covering cognitive topics such as self-assessment, strengths, attention, memory, planning, and problem-solving. Staff receive training and ongoing support to deliver CSM with fidelity. The study period lasts about 18 months, with the CSM sessions occurring during this time for the experimental group. Participants complete assessments at baseline, 6, 12, and 18 months in person, including cognitive tests, questionnaires, and employmenteducation history. Additional data such as medication, program use, hospitalizations, and weekly education and employment logs are collected regularly. Total participant time involves about 18 hours of study activities for the experimental group and about 6 hours for controls. After the study, control group participants still in CSC may be offered CSM if it fits their goals. The primary outcomes track school and work activity weekly and cognitive measures over time.

Age: 15Years - 32YearsAll GendersPhase Not Applicable
4 locations
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Actively Recruiting

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Age: 18Years +All Genders
2368 locations