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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Completed
CT.gov ID
NCT05982145
Collaborator
Sigvaris Corporation (Industry), Gerontopole Auvergne Rhone-Alpes (AURA) (Other)
39
1
16.5
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Individual interviews
  • Other: Focus groups
  • Other: Questionary and measures

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.

Study Design

Study Type:
Observational
Actual Enrollment :
39 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
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
Actual Study Start Date :
Feb 14, 2020
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
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
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 with / or had venous leg ulcers

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

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

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

Outcome Measures

Primary Outcome Measures

  1. data about leg's length [Months 5]

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

  2. data about measure of hydration [Months 5]

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

  3. data about the Group Iso Resource (GIR) [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. [Months 5]

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

Secondary Outcome Measures

  1. caregivers's experiences and representations about compression systems of venous leg ulcer [Months 6]

    Measure by individuals interviews

  2. patients' experiences and representations about compression systems of venous leg ulcer [Months 6]

    Measure by individuals interviews

Other Outcome Measures

  1. caregivers's in institution experiences and representations about the pathway of compression systems in institution [Months 18]

    Measure by Focus Groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gérontopole AURA Saint-Étienne France

Sponsors and Collaborators

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

Investigators

  • Study Chair: Nathalie Barth, PHD, Gerontopole Auvergne Rhone-Alpes (AURA)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT05982145
Other Study ID Numbers:
  • GA-2021-04
First Posted:
Aug 8, 2023
Last Update Posted:
Aug 8, 2023
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

Study Results

No Results Posted as of Aug 8, 2023