Out-of Pocket Payments in Patients With Lymphedema

Completed

• Conditions: Primary Lymphedema

• Registration Number: NCT02988479
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-09
• Primary Completion: 2017-10
• Study Completion: 2017-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean monthly out-of-pocket payment as assessed by an online self-questionnaire	6 months

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Montpellier, France