- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04555863
haMSter: a Novel Smartphone Communication Tool for People With MS
October 12, 2021 updated by: Patrick Altmann MD PhD, Medical University of Vienna
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Vienna, Austria, 1090
- Medical University of Vienna
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Any MS according to MacDonald criteria
- informed consent
Exclusion Criteria:
- language barriers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: haMSter app
Patients receiving the app for personal use for 6 months
|
the app tracks patient reported outcomes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adherence to device
Time Frame: over the course of this study (over 6 months)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall satisfaction with this application in telemedicine
Time Frame: after study completion (after 6 months)
|
TMPQ (Telemedicine Perception Questionnaire).
Min: 0 points.
Max: 80 Points.
Higher scores indicate a better outcome
|
after study completion (after 6 months)
|
General satisfaction with specific Features of the haMSter app
Time Frame: after study completion (after 6 months)
|
Empirical questionnaires.
We will Report frequencies of answers given.
There is no Overall score in a larger sense.
|
after study completion (after 6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Altmann P, Ponleitner M, Monschein T, Krajnc N, Zulehner G, Zrzavy T, Leutmezer F, Rommer PS, Kornek B, Berger T, Bsteh G. Feasibility of a smartphone app to monitor patient reported outcomes in multiple sclerosis: The haMSter interventional trial. Digit Health. 2022 Nov 4;8:20552076221135387. doi: 10.1177/20552076221135387. eCollection 2022 Jan-Dec.
- Altmann P, Hinterberger W, Leutmezer F, Ponleitner M, Monschein T, Zrzavy T, Zulehner G, Kornek B, Lanzenberger R, Berek K, Rommer PS, Berger T, Bsteh G. The Smartphone App haMSter for Tracking Patient-Reported Outcomes in People With Multiple Sclerosis: Protocol for a Pilot Study. JMIR Res Protoc. 2021 May 7;10(5):e25011. doi: 10.2196/25011.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
June 1, 2021
Study Registration Dates
First Submitted
September 14, 2020
First Submitted That Met QC Criteria
September 14, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Actual)
October 13, 2021
Last Update Submitted That Met QC Criteria
October 12, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1798/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
Individual participant data can only be shared after publication and upon reasonable request made to our local ethics review board.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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