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

NCT06090305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2025-01-30

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • University Hospital Schleswig-Holstein

    collaborator OTHER

  • Universität Duisburg-Essen

    collaborator OTHER

  • Gaia AG

    lead INDUSTRY

Principal Investigators

  • Kamila Jauch-Chara, MD · University Hospital Schleswig-Holstein

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2024-12-06
Completion
2024-12-06

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06090305 on ClinicalTrials.gov