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Evaluation of Allied Health Support Program for Adults with Untreated Unruptured Intracranial Aneurysms in a Randomized Controlled Trial
Led by Nantes University Hospital · Updated on 2024-11-27
340
Participants Needed
1
Research Sites
78 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate a support program for patients with untreated unruptured intracranial aneurysms ICAs. The study focuses on improving patient care by addressing the emotional impact and uncertainty associated with ICA diagnosis and monitoring. It combines a multicenter, cluster randomized controlled trial with a qualitative study to understand patients experiences and needs better. The intervention being studied is the CANHOPE allied health support program, which includes a post-diagnosis interview with allied health professionals, a follow-up phone call, a dedicated hotline for patient questions, and peer-patient focus groups occurring between months 3 and 10. The control group receives usual care, which involves standard neuroradiologist management and imaging follow-up with informational materials. Participants will complete questionnaires at baseline, 3, 10, and 18 months to measure anxiety levels, quality of life, depression, and perceived uncertainty about rupture risk. Additional assessments include individual interviews and monitoring of hotline use and focus group participation. The study evaluates the programs impact on anxiety using the Hospital Anxiety and Depression Scale at 10 months and tracks other psychosocial and economic outcomes over 18 months.
CONDITIONS
Brief Title
Patients with Unruptured IntraCranial ANeurysms: Evaluation of the Benefits of Allied Health FollOw-uP in a RandomizEd Controlled Trial
Research Team
S
Solène JOUAN
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