An Observational Study to Assess the Quality of Life of the Patients With Multiple Sclerosis and Their Caregivers

NCT01075737 | Completed

• 1 other identifier: 200077-501
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational, non controlled, non-interventional, multicentric, prospective study planned to be conducted in 450 subjects diagnosed with MS and their caregivers in 20 centres of Argentina. The observations from this study will contribute to the awareness of the impact on the Quality of Life (QoL) of the caregivers and, eventually will also provide measures for helping the subjects with multiple sclerosis (MS) without leaving aside the care of the physical and psychic health of those who work as caregivers.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Sclerosis; Quality of life

Outcome Measures

Primary Outcomes (1)

• Impact of MS on QoL of subjects diagnosed with multiple sclerosis (MS) and their caregivers

  SF-36 will be administered to subjects diagnosed with MS and their caregivers; Beck depression inventory and MS-Functional system scores to subjects diagnosed with MS.

  Each visit starting from the initial visit (Day 0) to end of the observation period (i.e. 24 months)

Secondary Outcomes (2)

• Correlation between QoL of subjects with MS and their caregivers

  During the observation period of 24 months starting from the initial visit (i.e. Day 0)

• Predictors of QoL of caregivers

  During the observation period of 24 months starting from the initial visit (i.e. Day 0)

Study Arms (2)

Subjects with Multiple Sclerosis

Subjects with diagnosed MS according to the revised Mc Donald criteria 2005; aged \>21 years.

Caregivers

Caregivers (aged \>21 years) for MS subjects.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with diagnosed MS and their caregivers in Argentinean population.

You may qualify if:

• MS subjects and their caregivers, \>21 years of age of both sexes
• Subjects who have signed informed consent
• Subjects with established MS diagnosis according to the revised Mc Donald criteria - 2005 with at least 1 year of evolution
• Subjects with MS that have an identified caregiver

You may not qualify if:

• Subjects with other(s) associated neurological, psychiatric or systemic disease(s)

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

25 de Mayo 138, Capital, Pcia. de

Santiago del Estero, G4200AWD, Argentina

Location

MeSH Terms

Conditions

Multiple Sclerosis; Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Miguel Jacobo, Neurologist

  25 de Mayo 138 (Capital, Pcia. de Santiago del Estero) G4200AWD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: August 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2012
• Last Updated: February 17, 2014

Record last verified: 2014-02

Locations

AR (1)