Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex)
NCT ID: NCT06090305
Last Updated: 2025-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
470 participants
INTERVENTIONAL
2023-11-20
2024-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
Participants allocated to the intervention group will receive access to levidex in addition to treatment as usual (TAU). levidex is a digital health application designed for individuals with Multiple Sclerosis (MS), accessible through a web browser. The application comprises 16 modules, with the majority focusing on treatment methods derived from cognitive behavioral therapy (CBT) and health behavior change. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 365 days.
levidex
Participants will receive access to the digital health application levidex in addition to treatment as usual (TAU).
treatment as usual (TAU)
treatment as usual (TAU)
Control group
Participants allocated to the control group will receive an overview of relevant brochures from the Deutsche Multiple Sklerose Gesellschaft (German Multiple Sclerosis Society) on the topic of lifestyle in Multiple Sclerosis (MS) in addition to treatment as usual (TAU). After 6 months, they will be offered access to levidex.
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).
treatment as usual (TAU)
treatment as usual (TAU)
Interventions
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levidex
Participants will receive access to the digital health application levidex in addition to treatment as usual (TAU).
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).
treatment as usual (TAU)
treatment as usual (TAU)
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital Schleswig-Holstein
OTHER
Universität Duisburg-Essen
OTHER
Gaia AG
INDUSTRY
Responsible Party
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Principal Investigators
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Kamila Jauch-Chara, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Schleswig-Holstein
Locations
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GAIA AG
Hamburg, , Germany
Countries
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Other Identifiers
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levidex RCT 2023
Identifier Type: -
Identifier Source: org_study_id
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