跳至主要内容
临床试验/NCT05982145
NCT05982145已完成不适用

The Use of Compression in Institutions and at People's Homes: A Satisfaction Study, Representations, Opinions and Expectations of Users and Caregivers and Creation of a Morphological Database. A Qualitative and Quantitative Multicentric Study

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2020年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
data about measure of hydration

研究概览

简要总结

The compression therapy is a main treatment for chronic venous disease and its different phases. It has proven its effectiveness and usefulness in preventive phase and curative phase. Gérontopôle AURA leads with his partner Sigvaris a large study about the compression in institutions and at patient's homes. Indeed, through 3 studies, the mains goals are to identify the facilities and difficulties about the use of the actual tools. The final aim is to propose a future compression device wich could be adapted and that responds to the needs of users and the realities of the field. First study: Construction of a representative morphological database of people who are 60 years old and older. Indeed, the actually sizing tables are not specifics so not adapted to the morphology of the wearer. This can have an impact on the effectiveness of the treatment and the comfort of the patient. Second study: Have a deep comprehension about the pathway of the compression stockings and bandage in public and private establishment specifically retirements homes for dependant elderly people and hospital. The objectives are to understand and identify the role of health professionals from prescription to implementation to the compressive tools and have their feeds backs. Moreover, the goal is to collect the uses and constraints related to compression systems and to identify the possible improvements, needs and hindrances in link with compressions products. Third study: Study of acceptability of a new adjustable compression solution for venous ulcers. The main goal is to understand the needs and expectations by the users and to know if a new adjustable compression system could be accepted by them. For that, it's important to have a feed back about the use of the compression by the caregivers, medical staff and patients and evaluate the comfort about the use of the compression at patient's home and in institutions. Getting their advices, opinions are necessary too.

详细描述

The mains goals are to identify the facilities and difficulties about the use of the actual tools. The final aim is to propose a future compression device wich could be adapted and that responds to the needs of users and the realities of the field.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Group 1 :
  • •Patients who are 60 years old and over Patients who have or not a compression therapy Patients who have a social security system Patients who have received information of the study and who approbate their participation
  • •Group 2 et 3 : People who have or had venous leg ulcers People who use or have used compression therapy People who can understand and exchange with the researcher People who have received information of the study and who approbate their participation
  • •Group 4 : Professionals who work in the investigated institution Professionals who have a link with patients who have a compression therapy Professionals who have received information of the study and who approbate their participation

排除标准

  • •Group 1 :
  • •Patients who refused to participate at the study Patients who are under 60 years old.
  • •Group 2 et 3 : People with cognitive disorders People who have no link with venous leg ulcers People who have or had wounds except venous leg ulcers People who refused to participate
  • •Group 4 : Professionals who have no link with patients who have compression therapy Profession who refused to participate

结局指标

主要结局

data about measure of hydration

时间窗: Months 5

Collect representative data about measure of hydration. Measure by questionary and taking measures

data about the Group Iso Resource (GIR)

时间窗: Months 5

Collect representative data about the Group Iso Resource (GIR). Measure by questionary and taking measures

data about leg's length

时间窗: Months 5

Collect representative data about leg's length. Measure by questionary and taking measures

data about the capacity of the person to getting out of the bed.

时间窗: Months 5

Collect representative data about the capacity of the person to getting out of the bed. Measure by questionary and taking measures

次要结局

  • caregivers's experiences and representations about compression systems of venous leg ulcer(Months 6)
  • patients' experiences and representations about compression systems of venous leg ulcer(Months 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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