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

Aging Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05982145
• Other study ID #: GA-2021-04
• Status: Completed
• Start date: February 14, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Other:
• Individual interviews
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
Identify facilities and difficulties in link with the prescription and implementation of the compression therapy everyday
• Questionary 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.

Locations

Country	Name	City	State
France	Gérontopole AURA	Saint-Étienne

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Gerontopole Auvergne Rhone-Alpes (AURA), Sigvaris Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	caregivers's in institution experiences and representations about the pathway of compression systems in institution	Measure by Focus Groups	Months 18
Primary	data about leg's length	Collect representative data about leg's length. Measure by questionary and taking measures	Months 5
Primary	data about measure of hydration	Collect representative data about measure of hydration. Measure by questionary and taking measures	Months 5
Primary	data about the Group Iso Resource (GIR)	Collect representative data about the Group Iso Resource (GIR). Measure by questionary and taking measures	Months 5
Primary	data about the capacity of the person to getting out of the bed.	Collect representative data about the capacity of the person to getting out of the bed. Measure by questionary and taking measures	Months 5
Secondary	caregivers's experiences and representations about compression systems of venous leg ulcer	Measure by individuals interviews	Months 6
Secondary	patients' experiences and representations about compression systems of venous leg ulcer	Measure by individuals interviews	Months 6