Evaluation of the Impact of Advanced Practice Nurses on Quality of Life in Primary Care in France (EQUIPAGE)
EQUIPAGE Trial: Protocol for a Pragmatic, Multicenter, Randomized Controlled Trial Evaluating the Impact of Advanced Practice Nurses (APNs) on Quality of Life in Primary Care in France
研究概览
详细说明
EQUIPAGE is a pragmatic, multicenter, open-label, randomized controlled superiority trial. A total of 880 adult patients with stable chronic conditions will be randomized (1:1) between standard care by GP alone and coordinated GP+APN care. The follow-up period is 24 months. The primary outcome measure is the change in physical quality of life at 12 months as measured by the SF-36. Secondary outcomes include hospitalizations, emergency department visits, mortality, adherence, and patient satisfaction. Analyses will be based on mixed-effects models accounting for repeated measures and the multicenter design.
This trial will provide the first randomized data on the impact of APNs in primary care in France and will help inform decisions regarding the organization of care.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Aurelie TROTIN
- 电话号码：+33687524814
- 邮箱：Aurelie.Trotin@univ-lemans.fr
研究联系人备份
- 姓名：Violaine DUMUR
- 邮箱：affaires-juridiques@univ-lemans.fr
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 18 years old or older patients,
- patients with a stable chronic condition falling under the indications defined by the french decree of July 18, 2018,
- patients under the care of a general practitioner (GP),
- patients who have signed an informed consent form.
Exclusion Criteria:
- patients with cognitive impairments that compromise their ability to participate in the study,
- patients who require exclusively medical care without the possibility of coordination,
- patients already receiving care in a setting that includes a primary care nurse;
- pregnant women;
- patients with no legal capacity.
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：CG + APN
|
A process evaluation will be conducted to document the implementation of the " intervention . It will focus on care pathways, the distribution of consultations, APN activities, deviations from the protocol, and the organizational characteristics of the facilities. |
|
无干预：GP alone
|
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 |
|---|---|---|
|
Change in physical quality of life
大体时间：12 months
|
The primary outcome is the change in physical quality of life at 12 months, measured by the physical composite score of the SF-36 questionnaire. This score aggregates four dimensions: physical activity, physical limitations, physical pain, and perceived health. The SF-36 is a validated tool for measuring health-related quality of life (Ware & Sherbourne, 1992). |
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Effectiveness of an MG+AP care pathway 1
大体时间：24 months
|
Measured by the number of unplanned hospitalizations and the number of visits to hospitals and/or emergency departments, in relation to the condition(s) justifying inclusion.
|
24 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Effectiveness of an MG+APN care pathway 2
大体时间：24 months
|
All-cause mortality reported in number of participant deaths, or similar
|
24 months
|
|
Therapeutic adherence
大体时间：12 and 24 months
|
Assessed using the GIRERD questionnaire (Girerd and al., 2001)
|
12 and 24 months
|
|
Evolution of the quality of life
大体时间：24 months
|
Assessed using the SF-36 questionnaire
|
24 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.