Out-of Pocket Payments in Patients With Lymphedema

Primary Lymphedema Clinical Trial

— Lymphorac2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988479
• Other study ID #: 9638
• Status: Completed
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

Inclusion criteria:

• Patient aged over six years, with primary 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.

Related Conditions & MeSH terms

• Lymphedema
• Primary Lymphedema

Intervention

Other:
• Out of pocket payments in patients

Locations

Country	Name	City	State
France	University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean monthly out-of-pocket payment as assessed by an online self-questionnaire		6 months