Multiple SclerosisLAMONTNCT06090305
Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex)
A study testing levidex and treatment as usual (TAU) in people with Multiple Sclerosis, run by Gaia AG at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- levidex and treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteGermany
- Study dates
- 20 Nov 2023to 6 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of severe impairment of independence or abilities (degree of care ["Pflegegrad", § 15 SGB XI] ≥ 3)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex): Randomized Controlled Trial
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
- Being tested
- levidex, Control, treatment as usual (TAU)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levidexBehavioural
Participants will receive access to the digital health application levidex in addition to treatment as usual (TAU).
ControlBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control; Other: treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after randomization
Secondary outcomes (6)
Patient Health Questionnaire (PHQ-9)
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.
Measured: 3 and 6 months after randomization
Work and Social Assessment Scale (WSAS)
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.
Measured: 3 and 6 months after randomization
Global index score of the Multiple Sclerosis International Quality of Life (MuSiQoL)
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.
Measured: 3 and 6 months after randomization
Generalized Anxiety Disorder Scale-7 (GAD-7)
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.
Measured: 3 and 6 months after randomization
Frenchay Activities Index (FAI)
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.
Measured: 3 and 6 months after randomization
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.
Measured: 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start20 Nov 2023
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Schleswig-Holstein, Universität Duisburg-Essen
- Responsible party
- Sponsor
- Investigators
- Kamila Jauch-Chara, MD, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090305
- Sponsor's protocol ID
- levidex RCT 2023
- Acronym
- LAMONT
- Status last verified
- Jan 2025
- First submitted
- 13 Oct 2023
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex): Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06090305
- Acronym / sponsor ID
- LAMONT / levidex RCT 2023
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Schleswig-Holstein, Universität Duisburg-Essen
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: levidex, Other: treatment as usual (TAU)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. |
| Control group | Active comparator | Behavioral: Control, Other: treatment as usual (TAU)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Presence of severe impairment of independence or abilities (degree of care ["Pflegegrad", § 15 SGB XI] ≥ 3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levidexParticipants will receive access to the digital health application levidex in addition to treatment as usual (TAU). | Behavioural | Intervention group |
| ControlParticipants 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). | Behavioural | Control group |
| treatment as usual (TAU)treatment as usual (TAU) | Other | Control group, Intervention group |
Primary outcome
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.
6 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: 3 and 6 months after randomization
Work and Social Assessment Scale (WSAS)
Time frame: 3 and 6 months after randomization
Global index score of the Multiple Sclerosis International Quality of Life (MuSiQoL)
Time frame: 3 and 6 months after randomization
Generalized Anxiety Disorder Scale-7 (GAD-7)
Time frame: 3 and 6 months after randomization
Frenchay Activities Index (FAI)
Time frame: 3 and 6 months after randomization
Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)
Time frame: 3 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamila Jauch-Chara, MD principal investigator
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing levidex and treatment as usual (TAU) in people with Multiple Sclerosis, run by Gaia AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS) (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.