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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05982145
Enrollment
39
Registered
2023-08-08
Start date
2020-02-14
Completion date
2021-06-30
Last updated
2023-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

Compression; Vein

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.

Interventions

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

OTHERFocus groups

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

OTHERQuestionary and measures

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.

Sponsors

Sigvaris Corporation
CollaboratorINDUSTRY
Gerontopole Auvergne Rhone-Alpes (AURA)
CollaboratorOTHER
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
data about leg's lengthMonths 5Collect representative data about leg's length. Measure by questionary and taking measures
data about measure of hydrationMonths 5Collect representative data about measure of hydration. Measure by questionary and taking measures
data about the Group Iso Resource (GIR)Months 5Collect representative data about the Group Iso Resource (GIR). Measure by questionary and taking measures
data about the capacity of the person to getting out of the bed.Months 5Collect representative data about the capacity of the person to getting out of the bed. Measure by questionary and taking measures

Secondary

MeasureTime frameDescription
caregivers's experiences and representations about compression systems of venous leg ulcerMonths 6Measure by individuals interviews
patients' experiences and representations about compression systems of venous leg ulcerMonths 6Measure by individuals interviews

Other

MeasureTime frameDescription
caregivers's in institution experiences and representations about the pathway of compression systems in institutionMonths 18Measure by Focus Groups

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026