NCT02377323

Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif

Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif on Employment Status, Quality of Life and Cognition: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Rebif has an impact on employment status, quality of life and cognition.

Detailed description

With this study the investigator plans to evaluate the impact of Rebif on the Real-Life Outcomes (RLO) of Multiple Sclerosis (MS) patients followed at the Clinic within the last two years, and with a follow-up of up to 18 years. The investigator will evaluate the employment outcomes with a questionnaire designed to document eventual changes in the employment status and other variables in the work conditions of the study participants. Furthermore, to evaluate the quality of life (QoL),eligible patients will be asked to complete the Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument, contains 52 items distributed into 12 scales, and two single items. This MS-specific QoL assessment tool uses the Short Form Health Survey (SF-36) as its generic core measure and includes 18 additional items under the following categories: health distress, sexual function, satisfaction with sexual function (one item), overall quality of life, cognitive function, energy, pain, and social function. A sub-group of patients will be selected to come to the clinic to undergo the cognitive portion of the study, using the well-known and validated battery of tests named Minimal Assessment of Cognitive Function in MS (MACFIMS battery). Socio-demographic data on education level, marital and family life will also be collected. All questionnaires (including the MSQoL-54) will be available by means of an online survey.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	MACFIMS	Cognitive evaluation of 50 participants
OTHER	MSQoL-54	Quality of life questionnaires

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-05-01
• Completion: 2016-12-01
• First posted: 2015-03-03
• Last updated: 2017-05-24

Locations

1 site across 1 country: Canada