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

Not Applicable

Recruiting

• Conditions: Unruptured Intracranial Aneurysm

• Registration Number: NCT06708078
• Lead Sponsor: Nantes University Hospital

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.
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Detailed Description

The aim of the CANHOPE study is to assess an allied health support program inspired by the experiences of patients with unruptured ICA managed in neuroradiology and guided by the uncertainty of illness theory, in order to sustain patients' hope.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-11-07
• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Primary Completion: 2026-11-06
• Study Completion: 2028-05-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety level based on the hospital anxiety depression scale (HADS)	10 months from baseline	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 appoint...

Secondary Outcome Measures

Name	Time	Method
Depression subscore of the hospital anxiety depression scale (HADS)	18 months from baseline	Responses to the hospital anxiety depression scale (HADS)
Subscores for the dimensions of the SF-36 questionnaire at months 3, 10 and 18	3, 10 and 18 months from baseline	Responses to the SF636 questionnaire assessing the quality of life
Self-assessment score for perceived uncertainty regarding the risk of intracranial Aneurysm rupture	3, 10 and 18 months from baseline	Scoring using a Likert scale
Differential cost-utility ratio comparing the CANHOPE allied health follow-up program to the usual management program	18 months from baseline	Differential cost-utility ratio comparing the CANHOPE allied health follow-up program to the usual management program, estimated from a collective perspective and over an 18-month time horizon, expressed as a cost for a gain of one year of life lived in perfect health (QALY, Quality-Adjusted Life Year) QALYs will be estimated from responses to the EQ-5D-5L q...
Duration of the phone call between Day 7 and Day 14	Between 7 and 14 days from baseline	Duration in minutes of the phone call made between Day 7 and Day 14 and items addressed checked off from a pre-established list in patients included in the CANHOPE allied health follow-up program.
Participation rate in focus groups	Between 9 and 18 months after baseline	Participation rate in focus groups calculated for patients included in the CANHOPE allied health follow-up program
Number of calls and reasons for calling the hotline	During the 18-month study period	Number of calls and reasons for calling the hotline in patients included in the CANHOPE allied health follow-up program
Depression and anxiety subscores of the hospital anxiety depression scale (HADS)	baseline	Responses to the depression and anxiety subscores of the hospital anxiety depression scale (HADS)
Dimensions of SF-36 and EQ-5D-5L questionnaires	baseline	Responses to the SF636 and EQ-5D-5L questionnaires assessing the quality of life
Baseline uncertainty level	baseline	Baseline uncertainty self-assessed using a Likert scale

Trial Locations

Locations (1)

CHU Nantes; 🇫🇷 Nantes, Loire-Atlantique, France