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

Gaia AG

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Behavioral: Control; Behavioral: levidex; Other: treatment as usual (TAU)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06090305

levidex RCT 2023

Details and patient eligibility

About

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.

Enrollment: 470 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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470 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: levidex

Other: treatment as usual (TAU)

Control group

Active Comparator group

Description:

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.

Treatment:

Other: treatment as usual (TAU)

Behavioral: Control