ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 7 for:    "Milroy disease"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02988505
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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 Type : Observational
Estimated Enrollment : 500 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
Study Start Date : September 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017



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


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988505


Contacts
Contact: Annie FRAYSSE +33467339223 a-fraysse@chu-montpellier.fr

Locations
France
Departement information Medicale CHU Montpellier Recruiting
Montpellier, France, 34000
Contact: GREGOIRE MERCIER, MD, Ph D         
Sponsors and Collaborators
University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02988505     History of Changes
Other Study ID Numbers: UF 9401
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases