Randomized-controlled trial investigating the effectiveness of a digital life-style intervention to improve quality of life in people with multiple sclerosis.

Randomized-controlled trial investigating the effectiveness of a digital life-style intervention to improve quality of life in people with multiple sclerosis. - DiQoLiMS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023023

Enrollment

422

Registered

2020-09-22

Start date

2020-11-12

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G35

Interventions

Group 1: Intervention group: access to online program levidex (+ access to information material) Group 2: Control group: access to information material (brochures about therapy supporting lifestyle wi

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Initial diagnosis of multiple sclerosis at least one year before study enrollment, specialist treatment in the last three months before study enrollment, sufficient cognitive and motor skills to use an online program, consent to participate in the study, sufficient understanding of the German language, access to the internet through own smartphone or computer

Exclusion criteria

Exclusion criteria: See inclusion criteria, psychotic diseases (e.g. schizophrenia), bipolar disorders, suicidal thoughts

Design outcomes

Primary

Measure	Time frame
MS-related quality of life six months post-baseline (total score of the Hamburg Quality of Life in MS questionnaire (HAQUAMS) version 10.1) (additionally 3 and 12 months after start of the study)	—

Secondary

Measure	Time frame
Well-being 3, 6 and 12 months post-baseline (WHO-5); disease-related functionality 3, 6 and 12 months after baseline (mean values of functional subscales of HAQUAMS); MS-related socioeconomic costs during months prior to assessment or the respective survey (days of hospitalization, days of incapacity to work, pharmacological treatment) Expected timeframe for participation is 12 months. Data will be assessed at the beginning of the study (T0), after three (T1), six (T2) and 12 months after beginning of the study (Follow-Up).	—

Measure

Time frame

Well-being 3, 6 and 12 months post-baseline (WHO-5); disease-related functionality 3, 6 and 12 months after baseline (mean values of functional subscales of HAQUAMS); MS-related socioeconomic costs during months prior to assessment or the respective survey (days of hospitalization, days of incapacity to work, pharmacological treatment) Expected timeframe for participation is 12 months. Data will be assessed at the beginning of the study (T0), after three (T1), six (T2) and 12 months after beginning of the study (Follow-Up).

—

Countries

Germany

Contacts

Public ContactAnja Specht

GAIA AG

team@levidex.de+49403510520

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026