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

Phase 4

• Conditions: G35; Multiple sclerosis

• Registration Number: DRKS00023023
• Lead Sponsor: GAIA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-22
• Study Completion: 2022-07-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 421

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)<br><br>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).