Out-of Pocket Payments With Lymphedema in France (Lymphorac)

February 26, 2019 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Montpellier, France, 34000
        • Departement information Medicale CHU Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All consecutive patients meeting the inclusion criteria will be included in each participating centre during the inclusion phase

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean monthly out-of-pocket payment as assessed by an online self-questionnaire
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 9, 2016

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 9401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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