Primary Lymphedema Secondary LymphedemaLymphoracNCT02988505
Out-of Pocket Payments With Lymphedema in France
An observational study of Primary Lymphedema Secondary Lymphedema, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Lymphedema is a frequent and chronic condition posing a high burden on patients. Clinical guidelines emphasize the role of compression therapy by prescription medical devices. Even in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist due to the price and reimbursement setting… Read more about this study
- Who is it for?
- Ages 6 to 80 years
- Conditions the study is for
- Primary Lymphedema Secondary Lymphedema
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2014to Dec 2017
- 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 6 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients meeting the inclusion criteria will be included in each participating centre during the inclusion phase
Who may be able to join
- Patient aged over six years, with primary or secondary lymphedema, regardless of the severity of the disease;
- Patient treated in one of the centres participating in the study;
- Patient (and her legal representative for minors) who gave her written consent [or did not refuse to participate, according to local Law] ;
- Patient with Internet access and an active email address.
Who cannot join
- Patients with concomitant chronic venous insufficiency;
- Patient not covered by any health care insurance scheme;
- People protected under the law.
Trial locations and contacts
1 site in 1 country.
France1 site
Departement information Medicale CHU Montpellier
Montpellier, 34000
About this study
Official title: Out-of Pocket Payments in Patients With Lymphedema in France and Inequities of Access ti Healthcare
Lymphedema is a frequent and chronic condition posing a high burden on patients. Clinical guidelines emphasize the role of compression therapy by prescription medical devices. Even in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist due to the price and reimbursement setting processes. OOPP may threaten the equity of care and drive patients to forgo care. Our aim was to analyze the distributive effects of OOPP for lymphedema patients in France.
A prospective, multicenter study will be conducted in France in 2014 on patients with lymphedema. Household ability to pay will be specified by net income and OOPP will be assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory and voluntary health insurance reimbursements will be considered. We will combine concentration curves and concentration indices to assess the distributive effects.
- Conditions
- Primary Lymphedema Secondary Lymphedema
- Being tested
- Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Also called Standard care including medical visits , drugs and medical devices
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean monthly out-of-pocket payment as assessed by an online self-questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start3 Sep 2014
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Lymphedema Secondary LymphedemaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988505
- Sponsor's protocol ID
- UF 9401
- Acronym
- Lymphorac
- Status last verified
- Aug 2016
- First submitted
- 2 Sep 2016
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Out-of Pocket Payments in Patients With Lymphedema in France and Inequities of Access ti Healthcare
- ClinicalTrials.gov ID
- NCT02988505
- Acronym / sponsor ID
- Lymphorac / UF 9401
- Conditions
- Primary Lymphedema Secondary Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 3 Sep 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Dec 2016 (estimated)
- 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.
Lymphedema is a frequent and chronic condition posing a high burden on patients. Clinical guidelines emphasize the role of compression therapy by prescription medical devices. Even in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist due to the price and reimbursement setting processes. OOPP may threaten the equity of care and drive patients to forgo care. Our aim was to analyze the distributive effects of OOPP for lymphedema patients in France.
A prospective, multicenter study will be conducted in France in 2014 on patients with lymphedema. Household ability to pay will be specified by net income and OOPP will be assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory and voluntary health insurance reimbursements will be considered. We will combine concentration curves and concentration indices to assess the distributive effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients meeting the inclusion criteria will be included in each participating centre during the inclusion phase
Key inclusion criteria (4 listed)
- Patient aged over six years, with primary or secondary lymphedema, regardless of the severity of the disease;
- Patient treated in one of the centres participating in the study;
- Patient (and her legal representative for minors) who gave her written consent [or did not refuse to participate, according to local Law] ;
- Patient with Internet access and an active email address.
Key exclusion criteria (3 listed)
- Patients with concomitant chronic venous insufficiency;
- Patient not covered by any health care insurance scheme;
- People protected under the law.
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 |
|---|---|---|
| Standard careAlso: Standard care including medical visits , drugs and medical devices | Other | – |
Primary outcome
The mean monthly out-of-pocket payment as assessed by an online self-questionnaire
Time frame: 6 months
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 27 Feb 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Primary Lymphedema Secondary Lymphedema, run by University Hospital, Montpellier 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 3 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 27 Feb 2019. 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?
The mean monthly out-of-pocket payment as assessed by an online self-questionnaire (time frame: 6 months). 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 27 Feb 2019.