M-healthNCT04555863
haMSter: a Novel Smartphone Communication Tool for People With MS
A study testing haMSter smartphone app in people with M-health and Multiple Sclerosis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- M-health, Multiple Sclerosis
- What is being tested?
- haMSter smartphone app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any MS according to MacDonald criteria
- informed consent
Who cannot join
- language barriers
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- M-health, Multiple Sclerosis
- Being tested
- haMSter smartphone app
- Keywords
- m-health, multiple sclerosis, patient reported outcomes
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
haMSter smartphone appDevice
the app tracks patient reported outcomes
| Study group | Role | What they receive |
|---|---|---|
| haMSter app | Experimental | Patients receiving the app for personal use for 6 months Receives: Device: haMSter smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence to device
Percentage (Number) of participants having completed all necessary questionnaires per study period. Max: 6 completions.
Measured: over the course of this study (over 6 months)
Secondary outcomes (2)
Overall satisfaction with this application in telemedicine
TMPQ (Telemedicine Perception Questionnaire). Min: 0 points. Max: 80 Points. Higher scores indicate a better outcome
Measured: after study completion (after 6 months)
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.
Measured: after study completion (after 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Apr 2020
- Primary completion1 Apr 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for M-healthStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Altmann MD PhD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555863
- Sponsor's protocol ID
- 1798/2019
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2020
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data can only be shared after publication and upon reasonable request made to our local ethics review board.
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.
PubMed 36353697Altmann 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.
PubMed 33960949
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- haMSter: a Novel Smartphone Communication Tool for People With MS
- ClinicalTrials.gov ID
- NCT04555863
- Acronym / sponsor ID
- 1798/2019
- Conditions
- M-health, Multiple Sclerosis
- Keywords
- m-health, multiple sclerosis, patient reported outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| haMSter app | Experimental | Device: haMSter smartphone appPatients receiving the app for personal use for 6 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Any MS according to MacDonald criteria
- informed consent
Key exclusion criteria (1 listed)
- language barriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| haMSter smartphone appthe app tracks patient reported outcomes | Device | haMSter app |
Primary outcome
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.
2 secondary outcomes
Overall satisfaction with this application in telemedicine
Time frame: after study completion (after 6 months)
General satisfaction with specific Features of the haMSter app
Time frame: after study completion (after 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Derived from this study: PubMed 36353697Altmann 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.
- Derived from this study: PubMed 33960949Altmann 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.
- Individual participant dataSharing planned: Undecided. Individual participant data can only be shared after publication and upon reasonable request made to our local ethics review board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing haMSter smartphone app in people with M-health and Multiple Sclerosis, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence to device (time frame: over the course of this study (over 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04555863, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.