Real-Life Outcomes of Multiple Sclerosis Treatment With Rebif on Employment Status, Quality of Life and Cognition: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Employment status
研究概览
简要总结
The purpose of this study is to determine whether Rebif has an impact on employment status, quality of life and cognition.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CIS or definite MS (RRMS or SPMS);
- •Patients seen at our Clinic within the last 2 years;
- •Patients untreated, or treated with either low dose or high dose Rebif for at least two years;
- •Patients between 18 to 60 years old at time of treatment initiation;
- •EDSS ≤ 5.5 at treatment initiation;
- •Patients able to read and write in French.
排除标准
- •Patients diagnosed with primary progressive MS;
- •Patients treated with other DMD, other than Rebif;
- •Co-existence of other diseases that could influence outcomes.
研究组 & 干预措施
Never treated
Patients never treated with a disease-modifying drug (DMD)
干预措施: MSQoL-54 (Other)
Treatment with Rebif
Patients treated with Rebif only, for at least two years, and for up to 18 years
干预措施: MACFIMS (Other)
Treatment with Rebif
Patients treated with Rebif only, for at least two years, and for up to 18 years
干预措施: MSQoL-54 (Other)
Never treated
Patients never treated with a disease-modifying drug (DMD)
干预措施: MACFIMS (Other)
结局指标
主要结局
Employment status
时间窗: baseline
The primary endpoint is the proportion of patients in each group belonging in the employment categories listed below: 1. Never worked 2. Work status unchanged 3. Work status changed: Not due to MS / Due to MS Sub-groups: 1. Full employment with accommodations 2. Part-time employment 3. Complete invalidity 4. Patient retired
次要结局
- Quality of life(Baseline)
- Cognitive function(Baseline)
研究者
Pierre Duquette
MD
Centre hospitalier de l'Université de Montréal (CHUM)