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

NCT06708078 | Recruiting

• 1 other identifier: RC22_0453
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unruptured Intracranial Aneurysm

Keywords

Unruptured intracranial Aneurysm; Neuroradiology; Patient's care pathway; Quality of life

Outcome Measures

Primary Outcomes (1)

• Anxiety level based on the hospital anxiety depression scale (HADS)

  Anxiety level measured by the anxiety subscore of the hospital anxiety depression scale (HADS) at month 10 (i.e., a few weeks before the first monitoring imaging). The choice of the 10-month timepoint corresponds to a waiting period shortly before the first imaging control of the aneurysm (usually at month 12). It is assumed that the proximity of the appointment may increase anxiety, which will then decrease or increase depending on the imaging findings: stable or unstable aneurysm.

  10 months from baseline

Secondary Outcomes (12)

• Depression subscore of the hospital anxiety depression scale (HADS)

  10 months from baseline

• Depression subscore of the hospital anxiety depression scale (HADS)

  3 months from baseline

• Depression subscore of the hospital anxiety depression scale (HADS)

  18 months from baseline

• Subscores for the dimensions of the SF-36 questionnaire at months 3, 10 and 18

  3, 10 and 18 months from baseline

• Self-assessment score for perceived uncertainty regarding the risk of intracranial Aneurysm rupture

  3, 10 and 18 months from baseline

Study Arms (2)

Canhope follow-up

EXPERIMENTAL

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.

Other: Follow-up according to the Canhope allied health support program

Usual Care

NO INTERVENTION

Announcement of a management by the neuroradiologist and frequency of imaging follow-up, information media

Interventions

Follow-up according to the Canhope allied health support program OTHER

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.

Canhope follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU Nantes

Nantes, Loire-Atlantique, 44, France

RECRUITING

Central Study Contacts

Solène JOUAN

CONTACT

+33244768539; solene.jouan@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic randomized controlled trial

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: November 7, 2023
• Primary Completion (Estimated): November 6, 2026
• Study Completion (Estimated): May 6, 2028
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From November the 6th of 2026

Locations

FR (1)