The Smartphone App haMSter for Tracking Patient-Reported Outcomes in People With Multiple Sclerosis: Protocol for a Pilot Study

Patrick Altmann, Werner Hinterberger, Fritz Leutmezer, Markus Ponleitner, Tobias Monschein, Tobias Zrzavy, Gudrun Zulehner, Barbara Kornek, Rupert Lanzenberger, Klaus Berek, Paulus Stefan Rommer, Thomas Berger, Gabriel Bsteh, Patrick Altmann, Werner Hinterberger, Fritz Leutmezer, Markus Ponleitner, Tobias Monschein, Tobias Zrzavy, Gudrun Zulehner, Barbara Kornek, Rupert Lanzenberger, Klaus Berek, Paulus Stefan Rommer, Thomas Berger, Gabriel Bsteh

Abstract

Background: Treatment and monitoring decisions in people with multiple sclerosis (MS) are based commonly on clinician-reported outcomes. These reflect physical and radiological disease activity and are the most relevant endpoints in clinical trials. Over the past few years, the number of studies evaluating so-called patient-reported outcomes (PROs) has been increasing. PROs are reports from patients concerning their own health perception. They are typically obtained by means of questionnaires and aim to quantify symptoms such as fatigue, depression, and sexual dysfunction. The emergence of PROs has made a tremendous contribution to understanding the individual impact of disease in people with MS and their health-related quality of life. However, the assessment of PROs consumes resources, including time and personnel. Thus, useful ways to conveniently introduce PROs into clinical practice are needed.

Objective: We aim to provide a rationale and pilot study protocol for a mobile health (mHealth) solution named "haMSter" that allows for remote monitoring of PROs in people with MS.

Methods: The core function of haMSter is to provide three scientifically validated PRO questionnaires relevant to MS for patients to fill out at home once a month. Thereby, longitudinal and remote documentation of PROs is enabled. A scoring algorithm graphically plots PRO scores over time and makes them available at the next visit.

Results: The pilot study is currently ongoing and will evaluate adherence to this mHealth solution in 50 patients over a period of 6 months. Results from the haMSter pilot study are expected in 2021.

Conclusions: haMSter is a novel mHealth-based solution for modern PRO research, which may constitute the first step in achieving the ability to integrate PROs in clinical practice. This allows for a more problem-oriented approach in monitoring visits, which addresses patient needs and ultimately saves time.

Trial registration: ClinicalTrials.gov NCT04555863; https://ichgcp.net/clinical-trials-registry/NCT04555863.

International registered report identifier (irrid): DERR1-10.2196/25011.

Keywords: mHealth; mobile health; multiple sclerosis; patient-reported outcomes; remote monitoring; telemedicine.

Conflict of interest statement

Conflicts of Interest: There are no direct conflicts of interest with respect to the establishment of this protocol. PA has participated in meetings sponsored by and received speaker honoraria or travel funding from Biogen, Merck, Roche, Sanofi-Genzyme, and Teva, and has received honoraria for consulting from Biogen. He received a research grant from Quanterix International and received funding for the development of the haMSter app from Biogen, Merck, Roche, Sanofi-Genzyme, and Teva. WH has nothing to declare. FL has participated in meetings sponsored by or received honoraria for acting as an advisor/speaker for Bayer, Biogen, Celgene, MedDay, Merck, Novartis, Roche, Sanofi-Genzyme, and Teva. MP has nothing to declare. TM has participated in meetings sponsored by or received travel funding from Biogen, Celgene, Merck, Novartis, Roche, Sanofi-Genzyme, and Teva. TZ has participated in meetings sponsored by or received travel funding from Biogen, Merck, Novartis, Roche, Sanofi-Genzyme, and Teva. GZ has nothing to declare. BK has received speaking honoraria or travel support from Biogen, Celgene, Merck, Novartis, Roche, Sanofi-Genzyme, and Teva, and gives advice to Biogen, Celgene, Merck, Novartis, Roche, and Sanofi-Genzyme. RL received conference speaker honoraria within the last 3 years from Bruker BioSpin MR and support from Siemens Healthcare regarding clinical research using PET/MR. He is a shareholder of the start-up company BM Health GmbH since 2019. KB has participated in meetings sponsored by and received travel funding from Roche. PSR has received honoraria for consultancy/speaking from AbbVie, Alexion, Almirall, Biogen, Merck, Novartis, Roche, Sandoz, and Sanofi-Genzyme, and has received research grants from Amicus, Biogen, Merck, and Roche. TB has participated in meetings sponsored by and received honoraria (lectures, advisory boards, and consultations) from pharmaceutical companies marketing treatments for multiple sclerosis, including Allergan, Almirall, Bayer, Biogen, Biologix, Bionorica, Celgene, MedDay, Merck, Novartis, Octapharma, Roche, Sanofi-Genzyme, Teva, and TG Pharmaceuticals. His institution has received financial support in the past 12 months by unrestricted research grants (Biogen, Merck, Novartis, Sanofi-Genzyme, and Teva) and for participation in clinical trials in multiple sclerosis sponsored by Alexion, Biogen, Merck, Novartis, Octapharma, Roche, Sanofi-Genzyme, and Teva. GB has participated in meetings sponsored by and received speaker honoraria or travel funding from Biogen, Celgene, Lilly, Merck, Novartis, Roche, Sanofi-Genzyme, and Teva, and has received honoraria for consulting from Biogen, Celgene, Novartis, Roche, and Teva.

©Patrick Altmann, Werner Hinterberger, Fritz Leutmezer, Markus Ponleitner, Tobias Monschein, Tobias Zrzavy, Gudrun Zulehner, Barbara Kornek, Rupert Lanzenberger, Klaus Berek, Paulus Stefan Rommer, Thomas Berger, Gabriel Bsteh. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 07.05.2021.

Figures

Figure 1
Figure 1
Overview of study enrollment, interventions, and assessments over the course of the haMSter pilot trial (Standard Protocol Items: Recommendations for Interventional Trials [SPIRIT] checklist). MS: multiple sclerosis; PRO: patient-reported outcome.
Figure 2
Figure 2
Screenshots of the the login screen (A), main menu screen (B), and a sample patient-reported outcome (PRO) question (C). The screenshots provided here have been translated from German to English for the purpose of this article. The lower end of the log-in screen reads “Programming of this app was funded by” and lists the corporate logos of pharmaceutical companies that provided funding for programming the haMSter app.
Figure 3
Figure 3
Sample entry for haMSterdiary. The screenshot provided here has been translated from German to English for the purpose of this article.
Figure 4
Figure 4
Screenshots of the patient-reported outcome (PRO) scoring information on the smartphone (A) and a printed score sheet (B). The screenshots provided here have been translated from German to English for the purpose of this article.

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