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Out-of Pocket Payments in Patients With Lymphedema (Lymphorac2)

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ClinicalTrials.gov Identifier: NCT02988479
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : December 9, 2016
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Primary Lymphedema Other: Out of pocket payments in patients

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Out-of Pocket Payments in Patients With Primary Lymphedema in France and Inequities of Access to Healthcare
Study Start Date : July 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : June 2017





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

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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 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): NCT02988479


Contacts
Contact: Gregoire MERCIER, MD, PhD +33467339109 g-mercier@chu-montpellier.fr
Contact: Annie FRAYSSE +33467339223 a-fraysse@chu-montpellier.fr

Locations
France
University Hospital Recruiting
Montpellier, France, 34295
Contact: Gregoire MERCIER, MD, PhD    +33467339109    g-mercier@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Gregoire MERCIER, MD, PHD University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02988479     History of Changes
Other Study ID Numbers: 9638
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases