G35
Conditions
Interventions
Group 1: Previous research has shown that certain health behaviour changes can improve quality of life , fatigue and other multiple sclerosis outcomes. Digital health applications may be well suited t
Sponsors
Institut für Neuroimmunologie und Multiple Sklerose, Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants have to be diagnosed with a clinically definite MS for more than one year. Participants must have an Expanded Disability Status Scale score between 3.5 and 7.5. The ability to use arm ergometry is mandatory. Moreover, participants are required to have internet access.
Exclusion criteria
Exclusion criteria: Persons with severely impaired vision, severe cognitive deficits or psychiatric disorders as well as a lack of ability to provide informed consent are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the feasibility and acceptability of levidex to determine whether participants find the intervention helpful and are able to apply the suggestions and techniques into their daily lives. This is measured at month 6 by usage data (Login numbers and programme completion) and a self-developed feasibility questionnaire (Likert-scale questions; free text questions which are analysed thematically and displayed in a mind map). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the impact of the intervention on patient empowerment, quality of life, depressive and anxiety symptoms, dietary behaviour, and physical activity. The following survey instruments will be used at baseline, month 3 and month 6: -Quality of Life (mean of the total score of the Hamburg Quality of Life in MS (HAQUAMS) questionnaire). -Depressive symptoms and anxiety symptoms (mean of the total score as well as the subscales of the Hospital Anxiety and Depression Scale (HADS) questionnaire) -Physical activity (mean of the Health Contribution score of the Godin-Leasure Time Exercise (GLTEQ) questionnaire as well as classification in activity categories) -Dietary behaviour (mean of the total score of a validated Diet Screener questionnaire as well as subanalysis of the 11 included food groups; analysis of nutrient intake data using the internet-based survey instrument myfood24 on 3 different days (baseline and month 6 only); question on vitamin D substitution). -Empowerment (mean score of the Patient Activation Measure (PAM) questionnaire) | — |
Countries
Germany
Contacts
Public ContactNicole Krause
Institut für Neuroimmunologie und Multiple Sklerose, Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed