haMSter: a Novel Smartphone Communication Tool for People With MS

NCT04555863 | Completed

• 1 other identifier: 1798/2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

M-health; Multiple Sclerosis

Keywords

m-health; multiple sclerosis; patient reported outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall satisfaction with this application in telemedicine

  after study completion (after 6 months)

• General satisfaction with specific Features of the haMSter app

  after study completion (after 6 months)

Study Arms (1)

haMSter app

EXPERIMENTAL

Patients receiving the app for personal use for 6 months

Device: haMSter smartphone app

Interventions

haMSter smartphone app DEVICE

the app tracks patient reported outcomes

haMSter app

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any MS according to MacDonald criteria
• informed consent

You may not qualify if:

• \- language barriers

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

• 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.

  PMID: 36353697 DERIVED

• 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.

  PMID: 33960949 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 21, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

AU (1)