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Out-of Pocket Payments in Patients With Lymphedema (Lymphorac2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02988479
Recruitment Status : Completed
First Posted : December 9, 2016
Last Update Posted : February 27, 2019
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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 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

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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. The mean monthly out-of-pocket payment as assessed by an online self-questionnaire [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consecutive patients meeting the inclusion criteria will be included in each participating centre during the inclusion phase

Inclusion criteria:

  • 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.

Exclusion criteria:

  • Patients with concomitant chronic venous insufficiency;
  • Patient not covered by any health care insurance scheme;
  • People protected under the law.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02988479

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University Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
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Principal Investigator: Gregoire MERCIER, MD, PHD University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier Identifier: NCT02988479     History of Changes
Other Study ID Numbers: 9638
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Lymphatic Diseases