Out-of Pocket Payments in Patients With Lymphedema (Lymphorac2)
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|ClinicalTrials.gov Identifier: NCT02988479|
Recruitment Status : Completed
First Posted : December 9, 2016
Last Update Posted : February 27, 2019
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.
|Condition or disease||Intervention/treatment|
|Primary Lymphedema||Other: Out of pocket payments in patients|
|Study Type :||Observational|
|Actual Enrollment :||108 participants|
|Official Title:||Out-of Pocket Payments in Patients With Primary Lymphedema in France and Inequities of Access to Healthcare|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||December 2017|
- The mean monthly out-of-pocket payment as assessed by an online self-questionnaire [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988479
|Montpellier, France, 34295|
|Principal Investigator:||Gregoire MERCIER, MD, PHD||University Hospital, Montpellier|