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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01075737
First received: February 24, 2010
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational Study to Assess the Quality of Life of the Caregivers of Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Impact of MS on QoL of subjects diagnosed with multiple sclerosis (MS) and their caregivers [ Time Frame: Each visit starting from the initial visit (Day 0) to end of the observation period (i.e. 24 months) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Correlation between QoL of subjects with MS and their caregivers [ Time Frame: During the observation period of 24 months starting from the initial visit (i.e. Day 0) ] [ Designated as safety issue: No ]
  • Predictors of QoL of caregivers [ Time Frame: During the observation period of 24 months starting from the initial visit (i.e. Day 0) ] [ Designated as safety issue: No ]

Enrollment: 141
Study Start Date: August 2008
Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

Caregivers of subjects diagnosed with MS have to take care of many activities of MS subjects that they cannot perform themselves, because of their lack of autonomy. The fact of aiding a person with some degree of disability due to a chronic disease in an intense way and for a long time could generate a high level of satisfaction in the caregiver; but at the same time the emotional and physical exhaustion of the caregiver increases as the disease progresses. The QoL of the person who is emotionally bonded to the MS subject as a caregiver has a great chance to be affected; and this is for sure more likely than in the case when the caregiver is a hired professional.

OBJECTIVES

Primary objective:

  • To identify the impact of MS on the QoL of the MS subjects and their caregivers

Secondary objectives:

  • To establish the correlation between the QoL of the subjects with MS and their caregivers
  • To identify the predictors of the QoL in the caregiver group

This is an observational, prospective and non-interventional study planned to be conducted in 20 centers in Argentina. The subjects with diagnosed MS will be managed with the clinical and therapeutic elements that their treating doctors considered appropriate, without modifying their decisions due to the subjects' inclusion into the study. The caregivers will be asked to complete the QoL questionnaire as a part of the normal interview on each and every visit. The total duration of the study is 24 months. A descriptive analysis will be performed for the demographic and clinical characteristics of the investigation subjects, as well as for the characteristics of the treatments they receive when they start their participation in this study. For the qualitative variables, treatment modifications, frequency tables and the percentages will be performed.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with diagnosed MS and their caregivers in Argentinean population.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subjects with other(s) associated neurological, psychiatric or systemic disease(s)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075737

Locations
Argentina
25 de Mayo 138, Capital, Pcia. de
Santiago del Estero, Argentina, G4200AWD
Sponsors and Collaborators
Merck KGaA
Investigators
Principal Investigator: Miguel Jacobo, Neurologist 25 de Mayo 138 (Capital, Pcia. de Santiago del Estero) G4200AWD
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01075737     History of Changes
Other Study ID Numbers: 200077-501
Study First Received: February 24, 2010
Last Updated: February 14, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Merck KGaA:
Multiple sclerosis
Sclerosis
Quality of life

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014