Acceptability of a digital health application to empower persons with multiple sclerosis with moderate to severe disability: Single-arm prospective pilot study
- Conditions
- G35Multiple sclerosis
- Registration Number
- DRKS00032667
- Lead Sponsor
- Institut für Neuroimmunologie und Multiple Sklerose, Universitätsklinikum Hamburg-Eppendorf
- Brief Summary
Out of 38 participants who completed the six-month intervention period, 18 (47.4%) completed the intervention. Participants rated the intervention positively in terms of practicability and acceptability and had only few points of criticism such as to include more physical exercise routine suggestions suitable for participants with severe impairment. Data on secondary endpoints showed no significant changes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 43
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.
Persons with severely impaired vision, severe cognitive deficits or psychiatric disorders as well as a lack of ability to provide informed consent are excluded.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method