Actively Recruiting
Patients with Unruptured Intracranial Aneurysms: Evaluation of the Benefits of Allied Health Follow-Up 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
On this page
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 program's 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with newly diagnosed (<9 months) untreated intracranial aneurysm
- Patient monitored by imaging for untreated intracranial aneurysm
- Patient aged 18 years or older
- Patient agrees to participate and has signed the consent form
You will not qualify if you...
- Patient with a history of ruptured intracranial aneurysm
- Patient under guardianship or curatorship
- Patient diagnosed with syndromes causing intracranial aneurysm, including Marfan syndrome, Aneurysm Osteoarthritis Syndrome with SMAD 3 mutations, type II and IV Ehlers Danlos syndrome, autosomal dominant polycystic kidney disease, or Moya-Moya syndrome
- Patient with dissecting or fusiform intracranial aneurysm
- Patient with intracranial aneurysm associated with an arteriovenous malformation
- Patient with blister-like intracranial aneurysm
- Patient with mycotic intracranial aneurysm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 9 months from diagnosis
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for baseline assessments and informed consent
Duration - 18 months
Participants receive tailored information and support through an interview with allied health professionals, a follow-up phone call, access to a support hotline, and peer-patient focus groups to help manage uncertainty and improve quality of life.
1 post-announcement interview, 1 phone call between Day 7 and Day 14, peer-patient focus group between month 3 and month 10, plus questionnaires at baseline, Month 3, Month 10, and Month 18
Duration - 18 months
Participants receive standard neuroradiologist management and imaging follow-up with informational materials as per usual care.
Questionnaires completed at baseline, Month 3, Month 10, and Month 18
Trial Site Locations
Total: 1 location
1
CHU Nantes
Nantes, Loire-Atlantique, France, 44
Actively Recruiting
Research Team
S
Solène JOUAN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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