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

NCT05982145 | Completed

• 1 other identifier: GA-2021-04
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

Compression; Vein

Outcome Measures

Primary Outcomes (4)

• data about leg's length

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

  Months 5

• data about measure of hydration

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

  Months 5

• data about the Group Iso Resource (GIR)

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

  Months 5

• 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 Outcomes (2)

• 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

Other Outcomes (1)

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

  Months 18

Study Arms (4)

Patients who are 60 years old and over

Patients who are 60 years old and over had a questionary and a measure of their leg's length

Other: Questionary and measures

Patients with / or had venous leg ulcers

Patients with / or had venous leg ulcers actually have individual interviews

Other: Individual interviews

Caregivers who treat patients with venous leg ulcers (except nursing homes)

Caregivers who treat patients with venous leg ulcers (except nursing homes) actually have individual interviews

Other: Individual interviews

Caregivers in nursing homes for dependant elderly people and institutions like hospital

Caregivers in nursing homes for dependant elderly people and institutions like hospital actually have focus groups

Other: Focus groups

Interventions

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

Caregivers who treat patients with venous leg ulcers (except nursing homes); Patients with / or had venous leg ulcers

Focus groups OTHER

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

Caregivers in nursing homes for dependant elderly people and institutions like hospital

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.

Patients who are 60 years old and over

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Sigvaris Corporation: collaborator
• Gerontopole Auvergne Rhone-Alpes (AURA): collaborator

Study Sites (1)

Gérontopole AURA

Saint-Etienne, France

Location

MeSH Terms

Interventions

Focus Groups; Weights and Measures

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nathalie Barth, PHD

  Gerontopole Auvergne Rhone-Alpes (AURA)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 8, 2023
• Study Start: February 14, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 8, 2023

Record last verified: 2021-08

Locations

FR (1)