Support program for patients with unruptured intracranial aneurysms
Patients with Unruptured IntraCranial ANeurysms: Evaluation of the Benefits of Allied Health FollOw-uP in a RandomizEd Controlled Trial
NA · Nantes University Hospital · NCT06708078
This study is testing a new support program to see if it helps people with unruptured intracranial aneurysms feel better and manage their condition more effectively.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Locations | 1 site (Nantes, Loire-Atlantique) |
| Trial ID | NCT06708078 on ClinicalTrials.gov |
What this trial studies
The CANHOPE program aims to evaluate the benefits of an allied health support initiative for patients with untreated unruptured intracranial aneurysms. This interventional study employs a cluster randomized controlled trial design alongside a qualitative study to gather insights from patients and caregivers. The program is inspired by the uncertainty of illness theory and seeks to enhance patient management and quality of life through tailored support. By addressing the inadequacies in the current care pathway, the study aims to provide valuable data for clinicians and decision-makers.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with newly diagnosed untreated intracranial aneurysms monitored by imaging.
Not a fit: Patients with a history of ruptured intracranial aneurysms or specific syndromes known to cause aneurysms may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and management of patients with unruptured intracranial aneurysms.
How similar studies have performed: While similar approaches have been explored, this specific program is novel in its focus on allied health support for unruptured intracranial aneurysms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with newly diagnosed (\<9 months) untreated Intracranial Aneurysm * Patient with untreated Intracranial Aneurysm monitored by imaging * Patient over 18 * Patient agreeing to participate in the study and having signed the consent form Exclusion Criteria: * Patient with a history of ruptured Intracranial Aneurysm * Patient under guardianship or curatorship * Patient diagnosed with a syndrome known to cause Intracranial Aneurysm : * Marfan syndrome * AOS (Aneurysm Osteoarthritis Syndrome) with SMAD 3 mutations * Type II and IV Elhers Danlos syndrome * Autosomal dominant polycystic fibrosis * Moya-Moya syndrome * Patient with: * Dissecting or fusiform Intracranial Aneurysm * Intracranial Aneurysm associated with an arteriovenous malformation * Blister-like Intracranial Aneurysm * Mycotic Intracranial Aneurysm
Where this trial is running
Nantes, Loire-Atlantique
- CHU Nantes — Nantes, Loire-Atlantique, France (RECRUITING)
Study contacts
- Study coordinator: Solène JOUAN
- Email: solene.jouan@chu-nantes.fr
- Phone: +33244768539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Unruptured Intracranial Aneurysm, Unruptured intracranial Aneurysm, Neuroradiology, Patient's care pathway, Quality of life