Clinical trial NCT06090305: Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex)
Official title: Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex): Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Schleswig-Holstein
name: Universität Duisburg-Essen
First posted: 2023-10-19
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 3 and 6 months after randomization
measure: Work and Social Assessment Scale (WSAS)
timeFrame: 3 and 6 months after randomization
measure: Global index score of the Multiple Sclerosis International Quality of Life (MuSiQoL)
timeFrame: 3 and 6 months after randomization
measure: Generalized Anxiety Disorder Scale-7 (GAD-7)
timeFrame: 3 and 6 months after randomization
measure: Frenchay Activities Index (FAI)
timeFrame: 3 and 6 months after randomization
measure: Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)
timeFrame: 3 months after randomization
Other outcomes:
measure: HALEMS Subscales (cognition; fatigue; mobility lower limb; mobility upper limb; communication; and mood)
timeFrame: 3 and 6 months after randomization
measure: Intake of disease-modifying drugs overall (last 3 months)
timeFrame: 3 and 6 months after randomization
measure: Intake of DMDs classified according to efficacy (category 1-3, according to current German clinical guideline) (last 3 months)
timeFrame: 3 and 6 months after randomization
measure: Number of days on sick leave/sick pay (last 3 months)
timeFrame: 3 and 6 months after randomization
measure: Number of days in inpatient treatment (last 3 months)
timeFrame: 3 and 6 months after randomization
Locations:
city: Hamburg
country: Germany
facility: GAIA AG
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Kamila Jauch-Chara, MD
role: PRINCIPAL_INVESTIGATOR
References: