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Completed

NCT Number: NCT06090305

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GAIA AG

Hamburg, 22085, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

levidex

Behavioral

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

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).

Treatment as usual (TAU)

Other

treatment as usual (TAU)

Primary outcomes

  1. Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)

    Time frame: 6 months after randomization

    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.

Secondary outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: 3 and 6 months after randomization

    The PHQ-9 measures depressive symptoms. Each of the 9 items is answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (almost every day). The total score ranges from 0 to 27. Higher scores represent higher depressive symptoms.

  2. Work and Social Assessment Scale (WSAS)

    Time frame: 3 and 6 months after randomization

    The WSAS measures an individual's perception of work and social functioning. It consists of 5 items that are answered on a 9-point Likert scale ranging from 0 (not at all impaired) to 8 (very severely impaired). The total score has a range of 0-40, with higher scores representing higher disability.

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

    Time frame: 3 and 6 months after randomization

    The MuSiQoL measures MS-specific quality of life. It comprises 31 items covering 9 domains (activities of daily living, psychological well-being, symptoms, relationships with friends, relationships with family, relationships with the healthcare system, sentimental and sexual life, coping, and rejection). Each item is scored on a 6-point Likert scale. The score on each dimension is obtained by computing the mean of the item scores for that dimension. All dimension scores are linearly transformed to a 0-100 scale. The global index score is computed as the mean of the dimension scores. Higher scores represent higher quality of life.

  4. Generalized Anxiety Disorder Scale-7 (GAD-7)

    Time frame: 3 and 6 months after randomization

    The GAD-7 is a 7-item self-report anxiety questionnaire. Items are rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score can range from 0 to 21, higher scores representing higher anxiety.

  5. Frenchay Activities Index (FAI)

    Time frame: 3 and 6 months after randomization

    The FAI assesses participation in social and lifestyle activities with 15 items that are scored on a 4-point Likert scale ranging from 1 to 4. It covers three subdomains (domestic chores, outdoor, work/leisure activities). The total score ranges from 15 to 60. Higher scores represent more activity.

  6. Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)

    Time frame: 3 months after randomization

    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.

Other outcomes

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

    Time frame: 3 and 6 months after randomization

    The HALEMS measures MS-specific quality of life. It covers the following domains: fatigue, thinking, mobility lower limb, mobility upper limb, communication and mood. each domain score ranges from 1 to 5. Higher scores represent lower quality of life.

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

    Time frame: 3 and 6 months after randomization

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

    Time frame: 3 and 6 months after randomization

  4. Number of days on sick leave/sick pay (last 3 months)

    Time frame: 3 and 6 months after randomization

  5. Number of days in inpatient treatment (last 3 months)

    Time frame: 3 and 6 months after randomization

Sponsors and collaborators

Lead sponsor

Gaia AG

Industry

Collaborators

  • University Hospital Schleswig-Holstein
  • Universität Duisburg-Essen

Registry information

Official study title

Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex): Randomized Controlled Trial

Acronym: LAMONT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2023
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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