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OpenTrials
Completed

NCT Number: NCT02988505

Out-of Pocket Payments With Lymphedema in France

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.

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Key information

Conditions

Primary Lymphedema Secondary Lymphedema

Age range

6 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Departement information Medicale CHU Montpellier

Montpellier, 34000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard care

Other

Other names: Standard care including medical visits , drugs and medical devices

Primary outcomes

  1. The mean monthly out-of-pocket payment as assessed by an online self-questionnaire

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Out-of Pocket Payments in Patients With Lymphedema in France and Inequities of Access ti Healthcare

Acronym: Lymphorac

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 9, 2016
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.