RecruitingNot ApplicableNCT06708078

Patients with Unruptured IntraCranial ANeurysms: Evaluation of the Benefits of Allied Health FollOw-uP in a RandomizEd Controlled Trial

Sponsor

Nantes University Hospital

Enrollment

340 participants

Start Date

Nov 7, 2023

Study Type

INTERVENTIONAL

Conditions

Unruptured Intracranial Aneurysm

Summary

The CANHOPE study falls within the scope of research on patients' experiences and the improvement of their management through interventions meeting their needs. The study protocol assesses a support program for patients with untreated intracranial aneurysms (ICAs), for whom several sources of data converge in describing inadequacies in patients' care pathway and a deleterious impact on their health. The initial questioning is based on the practice of caregivers, who are witnesses of patients' feelings during ICA follow-up and are sometimes unable to support them due to a lack of knowledge about the impact of the disease and an organization that does not provide any space dedicated to their support. The study topic described below explains the medical context of ICA, and the data available in the literature on the impact of this condition on patients' lives. These data are complemented by the results of a qualitative study recently conducted in Nantes University Hospital in 10 subjects who participated in two focus groups. The discussions have revealed many areas of tension related to the management of uncertainty: "questions arise after the consultation"; "there should be an ALLO INFO ANEURYSM number"; "if it ruptures, it's over, that's what I've understood"; "I fall asleep every night thinking it might be the last time". The need for specific support, particularly during the first year, appears to be obvious. Based on these experiences, it has been hypothesized that an allied health follow-up of patients managed by simple monitoring, focused on the management of uncertainty, during the first year following the announcement, could reduce anxiety and improve patients' quality of life. Inspired by participants' experiences and guided by the uncertainty in illness theory, the study is focused on proposing an allied health management organized around items known to sustain patients' hope. The aim of the CANHOPE study is therefore to assess the CANHOPE program, in order to provide clinicians and decision-makers with the data they need to support the implementation of this program in referral centers for ICA follow-up. This study will be conducted in two parallel parts: 1/ a multicenter, cluster, randomized, controlled trial and 2/ a comprehensive qualitative study.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria13

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

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Interventions

OTHERFollow-up according to the Canhope allied health support program

The Canhope allied health support program consists in: * providing information tailored to patients' needs, with a dedicated time for patients to ask questions, obtain answers tailored to their needs, and be aware of the resources available to them; * organizing peer-patient focus groups. And aims at: * reducing anxiety and improving patients' quality of life; * better taking into account the impact of the announcement of intracranial Aneurysm, and to provide them with specific support. * managing the emotional consequences of the announcement and the uncertainty of living with an intracranial Aneurysm.