Out-of Pocket Payments With Lymphedema in France

NCT02988505 | Completed

• 1 other identifier: UF 9401
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Lymphedema Secondary Lymphedema

Outcome Measures

Primary Outcomes (1)

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

  6 months

Interventions

Standard care OTHER

Also known as: Standard care including medical visits , drugs and medical devices

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Departement information Medicale CHU Montpellier

Montpellier, 34000, France

Location

MeSH Terms

Interventions

Standard of Care; Pharmaceutical Preparations; Equipment and Supplies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: December 9, 2016
• Study Start: September 3, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 27, 2019

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)