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Completed

NCT Number: NCT02592265

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Capability Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Economic Burden Financial Stress Immune System Diseases Nervous System Diseases Physical Disability Quality of Life Social Interaction Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The goal of this study is to evaluate prospectively the economic burden of Multiple Sclerosis (MS) in France by calculating direct costs (medical and non-medical) and indirect costs and by estimating consequences of MS on utility (QALY) of patients and caregivers in a societal perspective.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 1 year

    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

Secondary outcomes

  1. Score of social participation

    Time frame: 1 year

    Correlation between the score of social participation and health care costs of the disease will be determined

  2. Validity of life quality measurement EQ-5D

    Time frame: 1 year

    The EQ-5D index is a generic measure of health status that provides a simple descriptive profile and a single index value that can be used in the clinical and economic evaluation of health care

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

    Time frame: 1 year

    The SF-6D is a utility index based on a descriptive system composed of 11 items from six dimensions of the SF-36: physical functioning, role limitations, social functioning, pain, mental functioning and vitality.

  4. QALY

    Time frame: 1 year

    Health related quality in life will be measured as Quality adjusted life years (QALY)

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ECOPASEP

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Oct 30, 2015
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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