Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex): Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Gaia AG
- Enrollment
- 470
- Locations
- 1
- Primary Endpoint
- Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Outcomes
Primary Outcomes
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
- Patient Health Questionnaire (PHQ-9)(3 and 6 months after randomization)
- Work 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)
- Generalized Anxiety Disorder Scale-7 (GAD-7)(3 and 6 months after randomization)
- Frenchay Activities Index (FAI)(3 and 6 months after randomization)
- Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS)(3 months after randomization)