Prevention of Medical, Social, and Psychosocial Risks Following a Parkinson's Disease Diagnosis: A Pilot Study (PRIMS-PARK)
2026年5月4日 更新者:University Hospital, Toulouse
Parkinson's disease (PD) is the second most common neurodegenerative disease worldwide, with a prevalence expected to double by 2040.
The diagnosis of PD is often a shock for patients and their families, due to a lack of preparation and adequate support.
Progress has been made with the establishment of Parkinson's disease expert centers (PDECs) and better-structured care pathways, but limitations remain.
The needs of patients, their caregivers, and neurologists at the time of diagnosis were studied, leading to the development of a flexible, adaptable, and multidisciplinary home-based care pathway.
This pathway includes multimodal communication tools (booklet and website) and can also be used by caregivers.
The aim is to evaluate this pathway at the departmental level and its ability to prevent the medical, social, and psychosocial risks that complicate the care of patients newly diagnosed with PD.
Thus, offering the patient, their caregiver and their neurologist a truly flexible and local care pathway built according to their needs, from the moment the disease is announced, could allow for better acceptance of the disease, an improvement in quality of life, the adoption of beneficial practices as well as a patient-caregiver therapeutic alliance with good adherence to drug and non-drug therapies.
研究概览
研究类型
介入性
注册 (估计的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Fabienne ORY MAGNE, MD
- 电话号码:+33 0561775687
- 邮箱:ory.f@chu-toulouse.fr
学习地点
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Toulouse、法国、31300
- Service de Neurologie Cognitive, Comportementale et Mouvement anormaux CHU de Toulouse, Hôpital Pierre Paul Riquet, 31059 Toulouse Cedex 9
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
For patients:
- Patients with newly diagnosed Parkinson's disease (< 1 month)
- Over 18 years of age
For caregivers (if the caregiver does not wish to participate, the patient can be included):
- Primary caregiver of a patient with newly diagnosed Parkinson's disease (< 1 month)
- Over 18 years of age
Exclusion Criteria:
For patients
- Institutionalized patients
- Residents of an area not covered by the intervention zone of specialized neurodegenerative disease teams
For caregivers
- Participants who do not wish to participate
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:patients benefiting from a care pathway
patients benefiting from a flexible and local care pathway
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Patients will need to complete questionnaires to establish and evaluate their care pathway.
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其他:caregivers of Parkinson's disease patients
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Caregivers will need to complete questionnaires in order to establish and evaluate the care plan.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluate, in newly diagnosed Parkinson's patients, adherence to a new, flexible, and local care pathway after the announcement of the Parkinson's disease.
大体时间:6 months after the inclusion
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Percentage of patients who adhere to the program, i.e., who accept the partial or complete program according to their needs
|
6 months after the inclusion
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of the flexible and local care pathway based on the patient's medical and psychological parameters.
大体时间:6 months after the inclusion
|
Responses to the quality of life questionnaire at baseline and 6 months post-inclusion
|
6 months after the inclusion
|
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Evaluation of the flexible and local care pathway on the well-being of caregivers
大体时间:6 months after the inclusion
|
Caregiver responses to the quality of life questionnaire at baseline and 6 months post-inclusion
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6 months after the inclusion
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Evaluation of satisfaction with the flexible and local care pathway
大体时间:6 months after the inclusion
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Responses to the satisfaction questionnaire
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6 months after the inclusion
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年9月30日
研究完成 (估计的)
2028年3月31日
研究注册日期
首次提交
2026年5月4日
首先提交符合 QC 标准的
2026年5月4日
首次发布 (实际的)
2026年5月11日
研究记录更新
最后更新发布 (实际的)
2026年5月11日
上次提交的符合 QC 标准的更新
2026年5月4日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.