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Health and Quality of Life Assessment Project for Caregivers of Idiopathic Pulmonary Fibrosis Patients (HELP-IPF)

2022年4月14日 更新者:Centre Hospitalier Universitaire Dijon

Idiopathic pulmonary fibrosis (IPF) is a chronic, disabling disease characterized by a progressive and irreversible deterioration in respiratory function, resulting in impaired quality of life (QoL) and patient dependence.

The factors involved in the alteration of QoL in these patients are the physical symptoms related to fibrosis (dyspnea, cough, fatigue) and psychological symptoms (anxiety and depression) as well as social, relational and financial factors, the experience of the disease and disability, the time required for diagnosis, the information received, and the initiation of a treatment such as oxygen therapy.

Caregivers primarily in chronic diseases (so-called natural or informal caregivers) provide partial or total assistance to a dependent person for activities of daily living for care, social support and maintenance of autonomy, administrative procedures, psychological support, communication, domestic activities or even financial assistance, often despite their own exhaustion and health issues.

Recent studies on the QoL of patient-caregiver dyads in IPF through semi-structured interviews highlight the role of previously identified factors in caregivers as well.

Investigators want to confirm the data obtained in a large population of patients and their caregivers in order to evaluate the QoL of caregivers and confirm the impact of its various factors on it in order to suggest ways to improve the lives of both the caregiver and the patient.

The hypothesis of investigators' work is that the QoL of caregivers of patients with IPF is altered, particularly by the patient's functional symptoms (cough, dyspnea, fatigue, anxiety and depression), the arrival of oxygen therapy in the home and the caregiver's social isolation.

Investigators believe that there are links and interactions between the caregiver's and patient's quality of life and therefore have an impact on the patient's care.

研究概览

研究类型

观察性的

注册 (实际的)

151

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。

学习地点

      • Dijon、法国
        • CHU Dijon Bourgogne

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Consultation at the Reference or Competence Centre for Rare Adult Lung Diseases

描述

Inclusion Criteria:

Patient inclusion criteria:

  • Patient rescruited from prevalent cases and incidents of patients with IPF according to the diagnostic criteria of the 2011 ATS/ERS/JRS/ALAT recommendations, for which a follow-up is planned or is in progress
  • Patient with a validated IPF diagnosis in multidisciplinary discussion in a Competence or Reference Centre. Regardless of the stage of the disease.
  • Patient who has not opposed their enrollment in the study
  • Adult patient
  • Patient able to be assessed every 6 months by principal investigator
  • A patient who can designate a non-professional primary caregiver regardless of kinship, age or involvement with the patient (the primary caregiver is defined as the person who works most frequently with the patient). Only one caregiver is retained per patient.
  • Patient with no memory or comprehension problems and able to read and write French

Caregiver Inclusion Criteria:

  • Caregiver designated by the patient as his or her primary caregiver
  • Caregiver who has not opposed their participation in the study
  • Adult caregiver
  • Caregiver with no comprehension problems and able to read and write in French
  • Caregiver with no memory problems

Exclusion Criteria:

  • Person subject to a measure of legal protection (curatorship, guardianship)
  • Person with a legal guardian
  • Adult unable to consent

Patient non-inclusion criteria:

  • Psychiatric, cognitive or neurological disorders making assessment impossible
  • Patient suffering from another medical condition considered severe by the investigator and which may interfere with the consequences of IVF (for example, active cancers, motor disability of neurological origin, osteo-articular diseases inducing dependence...)
  • Not likely to complete a self-administered questionnaire

Caregiver non-inclusion criteria:

  • Psychiatric, cognitive or neurological disorders making assessment impossible
  • Not likely to complete a self-administered questionnaire

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

队列和干预

团体/队列
干预/治疗
patient-caregiver dyads
Measurement of quality of life at D0, M6 and M12 via SF-36, CarGOQoL and the one-dimensional Zarit score
Quality of life measurement at D0, M6 and M12 via the SF-36

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
The generic quality of life score SF-36 to measure caregivers' quality of life
大体时间:Through study completion, an average of 12 months
Measurement of caregivers' quality of life via the generic quality of life score SF-36 in each of the 8 dimensions of the component
Through study completion, an average of 12 months
The specific quality score CarGOQoL to measure caregivers' quality of life
大体时间:Through study completion, an average of 12 months
Measurement of caregivers' quality of life via the specific quality score CarGOQoL in each of the 10 dimensions of the component
Through study completion, an average of 12 months

次要结果测量

结果测量
措施说明
大体时间
"subjective burden" of caregivers
大体时间:Through study completion, an average of 12 months
Measurement of the "subjective burden" of caregivers via the one-dimensional Zarit score
Through study completion, an average of 12 months
Patients' Quality of life
大体时间:Through study completion, an average of 12 months
Measurement of patients' quality of life via the generic quality of life score SF-36 in each of the 8 dimensions
Through study completion, an average of 12 months

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 (实际的)

2019年10月14日

初级完成 (实际的)

2020年9月28日

研究完成 (实际的)

2021年12月15日

研究注册日期

首次提交

2019年7月22日

首先提交符合 QC 标准的

2019年7月23日

首次发布 (实际的)

2019年7月24日

研究记录更新

最后更新发布 (实际的)

2022年4月15日

上次提交的符合 QC 标准的更新

2022年4月14日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • BELTRAMO FRSR 2018

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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