Patients with Unruptured IntraCranial ANeurysms: Evaluation of the Benefits of Allied Health FollOw-uP in a RandomizEd Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Anxiety level based on the hospital anxiety depression scale (HADS)
研究概览
简要总结
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.
详细描述
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.
The CANHOPE program is designed 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 is conducted in two parallel parts: 1/ a cluster, randomized, controlled trial and 2/ a comprehensive qualitative study.
An intracranial aneurysm (ICA) is a localized dilation of the wall of a cerebral artery. So-called classical aneurysms are saccular and located in the main arteries of the circle of Willis. The mechanism(s) leading to the development and growth of aneurysms remain unclear (1). They develop next to a weakened area of the artery wall, most often at arterial bifurcations. A number of risk factors are known: female gender, smoking, high blood pressure, connective tissue disorders (within this category, the family forms of ruptured ICAs are mainly found in autosomal dominant polycystic kidney disease). ICAs are common anomalies, affecting 2-5% of the adult population, i.e. 1.2-3 million French people.
An ICA is complicated by its rupture, resulting in subarachnoid hemorrhage, characterized by a sudden "thunderclap" headache with loss of consciousness, leading to sudden death. Although aneurysm rupture is rare (<1% per year, with 6,000 cases per year in France), it is a serious event that can lead to major sequelae or even death. The mortality rate for this type of stroke ranges between 30 and 40%, and 3 out of 5 persons who survive are permanently disabled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Follow-up according to the Canhope allied health support program (Other)
Usual Care
Announcement of a management by the neuroradiologist and frequency of imaging follow-up, information media
结局指标
主要结局
Anxiety level based on the hospital anxiety depression scale (HADS)
时间窗: 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 appointment may increase anxiety, which will then decrease or increase depending on the imaging findings: stable or unstable aneurysm.
次要结局
- 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)
- Differential cost-utility ratio comparing the CANHOPE allied health follow-up program to the usual management program(18 months from baseline)
- Duration of the phone call between Day 7 and Day 14(Between 7 and 14 days from baseline)
- Participation rate in focus groups(Between 9 and 18 months after baseline)
- Number of calls and reasons for calling the hotline(During the 18-month study period)
- Depression and anxiety subscores of the hospital anxiety depression scale (HADS)(baseline)
- Dimensions of SF-36 and EQ-5D-5L questionnaires(baseline)
- Baseline uncertainty level(baseline)
- 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)