Measuring Consequences of Disability for Patients With Multiple Sclerosis and Caregivers on Economic Burden

NCT02592265 | Completed

• 1 other identifier: RC-P0018
• Study Type: observational
• Target: 233
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to measure economic burden of Multiple Sclerosis (MS) from a new point of view that includes consequences of disability on Quality Of Life (QOL), social participation and capabilities of patients and caregivers. To the investigators' knowledge, there is currently no data including intangible costs related to caregivers and calculating the overall economic cost of Multiple Sclerosis, particularly, in France.

Conditions

Multiple Sclerosis; Physical Disability; Economic Burden; Social Interaction; Capability; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Annual average total health care cost of the Multiple Sclerosis by patient

  Global cost of Multiple Sclerosis considering direct medical and non-medical costs as well as the indirect and intangible costs associated to the patient-caregiver

  1 year

Secondary Outcomes (4)

• Score of social participation

  1 year

• Validity of life quality measurement EQ-5D

  1 year

• Utilities measured by the Short Form-6D (SF-6D)

  1 year

• QALY

  1 year

Eligibility Criteria

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

Study Population

At least 230 patients in secondary and tertiary centers (8) affiliated to the regional supportive care network (GSEP) in north of France.

You may qualify if:

• Participant aged 18 or more
• Confirmed MS diagnosis (McDonald 2005)
• Defined type of MS according classification of Lublin and Reingold

You may not qualify if:

• Subject living in an institution
• Severe cognitive dysfunction preventing to answer questionnaire
• Subject already included in other clinical study (phase 1 to 3)

Sponsors & Collaborators

• Lille Catholic University: lead
• Université de Lille: collaborator
• Région Nord-Pas de Calais, France: collaborator
• La Ligue Française Contre la Sclérose en Plaques: collaborator
• Novartis: collaborator

MeSH Terms

Conditions

Multiple Sclerosis; Financial Stress

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Arnaud KWIATKOWSKI

  Groupement des Hôpitaux de l'Institut Catholique de Lille

  PRINCIPAL INVESTIGATOR

• Amélie LANSIAUX

  Groupement des Hôpitaux de l'Institut Catholique de LilleGroupement des Hôpitaux de l'Institut Catholique de Lille

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 11, 2015
• First Posted: October 30, 2015
• Study Start: October 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: June 1, 2016
• Last Updated: September 19, 2024

Record last verified: 2024-09