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Completed

NCT Number: NCT05982145

The Use of Compression in Institutions and at People's Homes

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gérontopole AURA

Saint-Etienne, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

individual interviews

Other

Identify the needs and expectations of the users about the compression therapy; Identify the possible facilities and difficulties in link with the management of the venous leg ulcers; Identify care experiences; Identify experiences about the actual compressions systems

Focus groups

Other

Identify facilities and difficulties in link with the prescription and implementation of the compression therapy everyday

Questionary and measures

Other

To take measurement of patients who lives in institution or at their home and take measure of hydration and some other measures like the Group Iso Resource (GIR) and the capacity of the person to getting out of the bed.

Primary outcomes

  1. data about leg's length

    Time frame: Months 5

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

  2. data about measure of hydration

    Time frame: Months 5

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

  3. data about the Group Iso Resource (GIR)

    Time frame: Months 5

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

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

    Time frame: Months 5

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

Secondary outcomes

  1. caregivers's experiences and representations about compression systems of venous leg ulcer

    Time frame: Months 6

    Measure by individuals interviews

  2. patients' experiences and representations about compression systems of venous leg ulcer

    Time frame: Months 6

    Measure by individuals interviews

Other outcomes

  1. caregivers's in institution experiences and representations about the pathway of compression systems in institution

    Time frame: Months 18

    Measure by Focus Groups

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Gerontopole Auvergne Rhone-Alpes (AURA)
  • Sigvaris Corporation

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 8, 2023
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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