Clinical trial NCT05982145: The Use of Compression in Institutions and at People's Homes
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: Compression; Vein
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Sigvaris Corporation
name: Gerontopole Auvergne Rhone-Alpes (AURA)
First posted: 2023-08-08
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Group 1 : People who are 60 years old and older
* Group 2 : Patients who had or have venous leg ulcers
* Group 3 : Caregivers who work near and treat patients with venous leg ulcers
* Group 4 : Caregivers in nursing homes and institutions like hospital

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: data about leg's length
timeFrame: Months 5
measure: data about measure of hydration
timeFrame: Months 5
measure: data about the Group Iso Resource (GIR)
timeFrame: Months 5
measure: data about the capacity of the person to getting out of the bed.
timeFrame: Months 5
Secondary outcomes:
measure: caregivers's experiences and representations about compression systems of venous leg ulcer
timeFrame: Months 6
measure: patients' experiences and representations about compression systems of venous leg ulcer
timeFrame: Months 6
Other outcomes:
measure: caregivers's in institution experiences and representations about the pathway of compression systems in institution
timeFrame: Months 18
Locations:
city: Saint-Étienne
country: France
facility: Gérontopole AURA
Study officials:
affiliation: Gerontopole Auvergne Rhone-Alpes (AURA)
name: Nathalie Barth, PHD
role: STUDY_CHAIR
References: