AgingNCT05982145
The Use of Compression in Institutions and at People's Homes
An observational study of Aging, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Individual interviews, Focus groups and Questionary and measures
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Individual interviews, Focus groups, Questionary and measures
- Keywords
- Compression; Vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual interviewsOther
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 groupsOther
Identify facilities and difficulties in link with the prescription and implementation of the compression therapy everyday
Questionary and measuresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Questionary and measures | |
| Patients with / or had venous leg ulcers | Patients with / or had venous leg ulcers actually have individual interviews Receives: 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 Receives: 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 Receives: Other: Focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
data about leg's length
Collect representative data about leg's length. Measure by questionary and taking measures
Measured: Months 5
data about measure of hydration
Collect representative data about measure of hydration. Measure by questionary and taking measures
Measured: Months 5
data about the Group Iso Resource (GIR)
Collect representative data about the Group Iso Resource (GIR). Measure by questionary and taking measures
Measured: 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
Measured: Months 5
Secondary outcomes (2)
caregivers's experiences and representations about compression systems of venous leg ulcer
Measure by individuals interviews
Measured: Months 6
patients' experiences and representations about compression systems of venous leg ulcer
Measure by individuals interviews
Measured: Months 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start14 Feb 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sigvaris Corporation, Gerontopole Auvergne Rhone-Alpes (AURA)
- Responsible party
- Sponsor
- Investigators
- Nathalie Barth, PHD, Study chair, Gerontopole Auvergne Rhone-Alpes (AURA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982145
- Sponsor's protocol ID
- GA-2021-04
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2021
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05982145
- Acronym / sponsor ID
- GA-2021-04
- Conditions
- Aging
- Keywords
- Compression; Vein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Sigvaris Corporation, Gerontopole Auvergne Rhone-Alpes (AURA)
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients who are 60 years old and over | – | Other: Questionary and measuresPatients who are 60 years old and over had a questionary and a measure of their leg's length |
| Patients with / or had venous leg ulcers | – | Other: Individual interviewsPatients with / or had venous leg ulcers actually have individual interviews |
| Caregivers who treat patients with venous leg ulcers (except nursing homes) | – | Other: Individual interviewsCaregivers who treat patients with venous leg ulcers (except nursing homes) actually have individual interviews |
| Caregivers in nursing homes for dependant elderly people and institutions like hospital | – | Other: Focus groupsCaregivers in nursing homes for dependant elderly people and institutions like hospital actually have focus groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual interviewsIdentify 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 | Other | Caregivers who treat patients with venous leg ulcers (except nursing homes), Patients with / or had venous leg ulcers |
| Focus groupsIdentify facilities and difficulties in link with the prescription and implementation of the compression therapy everyday | Other | Caregivers in nursing homes for dependant elderly people and institutions like hospital |
| Questionary and measuresTo 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. | Other | Patients who are 60 years old and over |
Primary outcome
data about leg's length
Time frame: Months 5
Collect representative data about leg's length. Measure by questionary and taking measures
data about measure of hydration
Time frame: Months 5
Collect representative data about measure of hydration. Measure by questionary and taking measures
data about the Group Iso Resource (GIR)
Time frame: Months 5
Collect 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.
Time frame: Months 5
Collect representative data about the capacity of the person to getting out of the bed. Measure by questionary and taking measures
2 secondary outcomes
caregivers's experiences and representations about compression systems of venous leg ulcer
Time frame: Months 6
patients' experiences and representations about compression systems of venous leg ulcer
Time frame: Months 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Barth, PHD study chair
Gerontopole Auvergne Rhone-Alpes (AURA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
data about leg's length (time frame: Months 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.