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Sponsor: Gaia AG
Conditions: Multiple Sclerosis
Interventions: levidex, Control, treatment as usual (TAU)
Countries: Germany
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Age ≥ 18 * 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 Exclusion Criteria: * Presence of severe impairment of independence or abilities (degree of care \["Pflegegrad", § 15 SGB XI\] ≥ 3)
- Hamburg, Germany