NCT06090305Completed
Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex)
Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex): Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 30 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 470 (actual)
- First submitted
- 13 Oct 2023
- Start date
- 20 Nov 2023
- Primary completion date
- 6 Dec 2024
- Lead sponsor
- Gaia AG
- Diseases
- Multiple sclerosis
- NCT number
- NCT06090305
What you commit to
- Study type: Interventional
- Participants enrolled: 470
- From 20 Nov 2023 to the primary completion date, 6 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of severe impairment of independence or abilities (degree of care \["Pflegegrad", § 15 SGB XI\] ≥ 3)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GAIA AG Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.