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haMSter: a Novel Smartphone Communication Tool for People With MS

Primary Purpose

M-health, Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
haMSter smartphone app
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for M-health focused on measuring m-health, multiple sclerosis, patient reported outcomes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any MS according to MacDonald criteria
  • informed consent

Exclusion Criteria:

- language barriers

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

haMSter app

Arm Description

Patients receiving the app for personal use for 6 months

Outcomes

Primary Outcome Measures

adherence to device
Percentage (Number) of participants having completed all necessary questionnaires per study period. Max: 6 completions.

Secondary Outcome Measures

Overall satisfaction with this application in telemedicine
TMPQ (Telemedicine Perception Questionnaire). Min: 0 points. Max: 80 Points. Higher scores indicate a better outcome
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.

Full Information

First Posted
September 14, 2020
Last Updated
October 12, 2021
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04555863
Brief Title
haMSter: a Novel Smartphone Communication Tool for People With MS
Official Title
haMSter: a Novel Smartphone Communication Tool for People With MS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. Endpoints include the adherence to this app and satisfaction with this Intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
M-health, Multiple Sclerosis
Keywords
m-health, multiple sclerosis, patient reported outcomes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
haMSter app
Arm Type
Experimental
Arm Description
Patients receiving the app for personal use for 6 months
Intervention Type
Device
Intervention Name(s)
haMSter smartphone app
Intervention Description
the app tracks patient reported outcomes
Primary Outcome Measure Information:
Title
adherence to device
Description
Percentage (Number) of participants having completed all necessary questionnaires per study period. Max: 6 completions.
Time Frame
over the course of this study (over 6 months)
Secondary Outcome Measure Information:
Title
Overall satisfaction with this application in telemedicine
Description
TMPQ (Telemedicine Perception Questionnaire). Min: 0 points. Max: 80 Points. Higher scores indicate a better outcome
Time Frame
after study completion (after 6 months)
Title
General satisfaction with specific Features of the haMSter app
Description
Empirical questionnaires. We will Report frequencies of answers given. There is no Overall score in a larger sense.
Time Frame
after study completion (after 6 months)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any MS according to MacDonald criteria informed consent Exclusion Criteria: - language barriers
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Individual participant data can only be shared after publication and upon reasonable request made to our local ethics review board.
Citations:
PubMed Identifier
36353697
Citation
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.
Results Reference
derived
PubMed Identifier
33960949
Citation
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.
Results Reference
derived

Learn more about this trial

haMSter: a Novel Smartphone Communication Tool for People With MS

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