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
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 with untreated Intracranial Aneurysm monitored by imaging
- Patient over 18
- Patient agreeing to participate in the study and having 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 Marfan syndrome
- Patient diagnosed with Aneurysm Osteoarthritis Syndrome (AOS) with SMAD 3 mutations
- Patient diagnosed with Type II or IV Ehlers Danlos syndrome
- Patient diagnosed with autosomal dominant polycystic fibrosis
- Patient diagnosed with 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
Trial Site Locations
Total: 1 location
1
CHU Nantes
Nantes, Loire-Atlantique, France, 44
Actively Recruiting
Research Team
S
Solène JOUAN
CONTACT
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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