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

NCT06090305 | Completed

• 1 other identifier: levidex RCT 2023
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)

  The HALEMS measures MS-specific quality of life. It covers the following domains: fatigue, thinking, mobility lower limb, mobility upper limb, communication and mood. The total score is calculated as the average of the scores in the six domains and ranges from 1 to 5. Higher scores represent lower quality of life.

  6 months after randomization

Secondary Outcomes (6)

• Patient Health Questionnaire (PHQ-9)

  3 and 6 months after randomization

• Work and Social Assessment Scale (WSAS)

  3 and 6 months after randomization

• Global index score of the Multiple Sclerosis International Quality of Life (MuSiQoL)

  3 and 6 months after randomization

• Generalized Anxiety Disorder Scale-7 (GAD-7)

  3 and 6 months after randomization

• Frenchay Activities Index (FAI)

  3 and 6 months after randomization

Other Outcomes (5)

• HALEMS Subscales (cognition; fatigue; mobility lower limb; mobility upper limb; communication; and mood)

  3 and 6 months after randomization

• Intake of disease-modifying drugs overall (last 3 months)

  3 and 6 months after randomization

• Intake of DMDs classified according to efficacy (category 1-3, according to current German clinical guideline) (last 3 months)

  3 and 6 months after randomization

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

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

Control group

ACTIVE COMPARATOR

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.

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

Interventions

levidex BEHAVIORAL

Participants will receive access to the digital health application levidex in addition to treatment as usual (TAU).

Intervention group

Control BEHAVIORAL

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).

Control group

treatment as usual (TAU) OTHER

treatment as usual (TAU)

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Impaired health-related quality of life (total score of the Hamburg Quality of Life Questionnaire for Multiple Sclerosis \[HALEMS\] ≥ 2)
• 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

You may not qualify if:

• Presence of severe impairment of independence or abilities (degree of care \["Pflegegrad", § 15 SGB XI\] ≥ 3)

Sponsors & Collaborators

• Gaia AG: lead
• University Hospital Schleswig-Holstein: collaborator
• Universität Duisburg-Essen: collaborator

Study Sites (1)

GAIA AG

Hamburg, 22085, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kamila Jauch-Chara, MD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: November 20, 2023
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)