Multiple Sclerosis Clinical Trial
Official title:
haMSter: a Novel Smartphone Communication Tool for People With MS
| NCT number | NCT04555863 |
| Other study ID # | 1798/2019 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 1, 2020 |
| Est. completion date | June 1, 2021 |
| Verified date | October 2021 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
haMSter is a smartphone app that tracks validated patient reported outcome measures (PROMs) in people multiple sclerosis (MS). In this study, 50 patients with MS will receive this app for 6 months and be asked to fill out the PRO questionnaires on their Smartphone. Endpoints include the adherence to this app and satisfaction with this Intervention.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | June 1, 2021 |
| Est. primary completion date | April 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Any MS according to MacDonald criteria - informed consent Exclusion Criteria: - language barriers |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | adherence to device | Percentage (Number) of participants having completed all necessary questionnaires per study period. Max: 6 completions. | over the course of this study (over 6 months) | |
| Secondary | Overall satisfaction with this application in telemedicine | TMPQ (Telemedicine Perception Questionnaire). Min: 0 points. Max: 80 Points. Higher scores indicate a better outcome | after study completion (after 6 months) | |
| Secondary | General satisfaction with specific Features of the haMSter app | Empirical questionnaires. We will Report frequencies of answers given. There is no Overall score in a larger sense. | after study completion (after 6 months) |
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