Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex): Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gaia AG
- 入组人数
- 470
- 试验地点
- 2
- 主要终点
- Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)
研究概览
简要总结
The trial aims to evaluate the effectiveness of a novel digital health application (levidex), which was designed to increase quality of life in persons with multiple sclerosis (MS). Therefore, 470 people with MS will be recruited and randomized to two groups: (1) an intervention group that will receive access to levidex in addition to treatment as usual (TAU) (n = 235) and (2) a control group receiving an overview of relevant brochures from the Deutsche Multiple Sklerose Gesellschaft (German Multiple Sclerosis Society) on the topic of lifestyle in MS in addition to TAU (n = 235).The primary outcome measure is the total score on the Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS), collected 6 months post-randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Impaired health-related quality of life (total score of the Hamburg Quality of Life Questionnaire for Multiple Sclerosis [HALEMS] ≥ 2)
- •Specialist treatment in the last three months before study inclusion
- •Diagnosis of MS (relevant ICD-10-GM diagnoses G35.x), confirmed by a medical document or equivalent certificate
- •Sufficient cognitive and motor skills to use an online program
- •Consent to participate
- •Sufficient knowledge of the German language
- •Access to the Internet
排除标准
- •Presence of severe impairment of independence or abilities (degree of care ["Pflegegrad", § 15 SGB XI] ≥ 3)
结局指标
主要结局
Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)
时间窗: 6 months after randomization
The HALEMS measures MS-specific quality of life. It covers the following domains: fatigue, thinking, mobility lower limb, mobility upper limb, communication and mood. The total score is calculated as the average of the scores in the six domains and ranges from 1 to 5. Higher scores represent lower quality of life.
次要结局
- Patient Health Questionnaire (PHQ-9)(3 and 6 months after randomization)
- Work and Social Assessment Scale (WSAS)(3 and 6 months after randomization)
- Global index score of the Multiple Sclerosis International Quality of Life (MuSiQoL)(3 and 6 months after randomization)
- Generalized Anxiety Disorder Scale-7 (GAD-7)(3 and 6 months after randomization)
- Frenchay Activities Index (FAI)(3 and 6 months after randomization)
- Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)(3 months after randomization)