Status:
COMPLETED
Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex)
Lead Sponsor:
Gaia AG
Collaborating Sponsors:
University Hospital Schleswig-Holstein
Universität Duisburg-Essen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 peo...
Eligibility Criteria
Inclusion
- 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
- Presence of severe impairment of independence or abilities (degree of care \["Pflegegrad", § 15 SGB XI\] ≥ 3)
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2024
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT06090305
Start Date
November 20 2023
End Date
December 6 2024
Last Update
January 30 2025
Active Locations (1)
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1
GAIA AG
Hamburg, Germany, 22085