Primary LymphedemaLymphorac2NCT02988479
Out-of Pocket Payments in Patients With Lymphedema
An observational study of Primary Lymphedema, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Primary lymphedema is a 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
- What is being tested?
- Out of pocket payments in patients
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to 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 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.
About this study
Official title: Out-of Pocket Payments in Patients With Primary Lymphedema in France and Inequities of Access to Healthcare
Primary lymphedema is a 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. The investigators aim was to analyze the distributive effects of OOPP for primary lymphedema patients in France.
A prospective, multicenter study will be conducted in France in 2015 on patients with primary 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. The investigators will combine concentration curves and concentration indices to assess the distributive effects.
- Conditions
- Primary Lymphedema
- Being tested
- Out of pocket payments in patients
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Out of pocket payments in patientsOther
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 startJul 2016
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregoire MERCIER, MD, PHD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988479
- Sponsor's protocol ID
- 9638
- Acronym
- Lymphorac2
- Status last verified
- Feb 2019
- First submitted
- 2 Sep 2016
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mercier G, Pastor J, Clement V, Rodts U, Moffat C, Quere I. Out-of-pocket payments, vertical equity and unmet medical needs in France: A national multicenter prospective study on lymphedema. PLoS One. 2019 May 8;14(5):e0216386. doi: 10.1371/journal.pone.0216386. eCollection 2019.
PubMed 31067244
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 Primary Lymphedema in France and Inequities of Access to Healthcare
- ClinicalTrials.gov ID
- NCT02988479
- Acronym / sponsor ID
- Lymphorac2 / 9638
- Conditions
- Primary Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2017 (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.
Primary lymphedema is a 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. The investigators aim was to analyze the distributive effects of OOPP for primary lymphedema patients in France.
A prospective, multicenter study will be conducted in France in 2015 on patients with primary 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. The investigators 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 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 |
|---|---|---|
| Out of pocket payments in patients | 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.
- Derived from this study: PubMed 31067244Mercier G, Pastor J, Clement V, Rodts U, Moffat C, Quere I. Out-of-pocket payments, vertical equity and unmet medical needs in France: A national multicenter prospective study on lymphedema. PLoS One. 2019 May 8;14(5):e0216386. doi: 10.1371/journal.pone.0216386. eCollection 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.
Gregoire MERCIER, MD, PHD principal investigator
University Hospital, Montpellier
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, 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?
On the ClinicalTrials.gov record for NCT02988479, which also lists 1 linked publication.
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.