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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075737
• Other study ID #: 200077-501
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: February 14, 2014
• Start date: August 2008
• Est. completion date: March 2012

Study information

• Verified date: February 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: March 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Argentina	25 de Mayo 138, Capital, Pcia. de	Santiago del Estero

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	Predictors of QoL of caregivers		During the observation period of 24 months starting from the initial visit (i.e. Day 0)	No