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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Nantes
RECRUITING
Nantes
Contact Information
Primary
Solène JOUAN
solene.jouan@chu-nantes.fr
+33244768539
Time Frame
Start Date: 2023-11-07
Estimated Completion Date: 2028-05-06
Participants
Target number of participants: 340
Treatments
Experimental: Canhope follow-up
Day 0: Post-announcement interview with allied health professionals (information and support interview) and then between Day 7 and Day 14, phone call (support relationship, answers to questions), followed by a hotline dedicated to questions. Between month 3 and month 10: patient focus group.
No_intervention: Usual Care
Announcement of a management by the neuroradiologist and frequency of imaging follow-up, information media
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov