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

• ClinicalTrials.gov Identifier: NCT02988505
• Recruitment Status: Completed
• First Posted: December 9, 2016
• Last Update Posted: February 27, 2019
• Sponsor: University Hospital, Montpellier
• Information provided by (Responsible Party): University Hospital, Montpellier

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Primary Lymphedema Secondary Lymphedema	Other: Standard care

Study Design

• Study Type: Observational
• Actual Enrollment: 260 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Out-of Pocket Payments in Patients With Lymphedema in France and Inequities of Access ti Healthcare
• Actual Study Start Date: September 3, 2014
• Actual Primary Completion Date: December 2016
• Actual Study Completion Date: December 2017

Groups and Cohorts

Intervention Details:

• Other: Standard care
  Other Name: Standard care including medical visits , drugs and medical devices

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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

Criteria

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.

Contacts and Locations

Locations

France

Departement information Medicale CHU Montpellier

Montpellier, France, 34000

Sponsors and Collaborators

University Hospital, Montpellier

More Information

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT02988505
• Other Study ID Numbers: UF 9401
• First Posted: December 9, 2016
• Last Update Posted: February 27, 2019
• Last Verified: August 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Lymphedema; Lymphatic Diseases