Effectiveness of a Digital Health Application for Multiple Sclerosis (
Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex): Randomized Controlled Trial
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 23 months ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- levidex
Compared with
- Control
Given to everyone in the trial
- treatment as usual (TAU)
What it measured
Main measures
Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)
6 months after randomization
FatigueWalking and mobilityArm and hand functionMood and sleepQuality of life (reported by participants)
Other measures (6)
Patient Health Questionnaire (PHQ-9)
3 and 6 months after randomization
Mood and sleepWork 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
Bladder, bowel and sexual functionQuality of life (reported by participants)Generalized Anxiety Disorder Scale-7 (GAD-7)
3 and 6 months after randomization
Mood and sleepFrenchay Activities Index (FAI)
3 and 6 months after randomization
Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)
3 months after randomization
FatigueWalking and mobilityArm and hand functionMood and sleepQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 and over
Show the full 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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Nov 2023
Main results due
Dec 2024
Finished
Dec 2024