NCT06090305

Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex)

Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex): Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Gaia AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BEHAVIORAL	levidex	Participants will receive access to the digital health application levidex in addition to treatment as usual (TAU).
BEHAVIORAL	Control	Participants will receive access to 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 treatment as usual (TAU).
OTHER	treatment as usual (TAU)	treatment as usual (TAU)

Timeline

• Start date: 2023-11-20
• Primary completion: 2024-12-06
• Completion: 2024-12-06
• First posted: 2023-10-19
• Last updated: 2025-01-30

Locations

1 site across 1 country: Germany