The Smartphone App haMSter for Tracking Patient-Reported Outcomes in People With Multiple Sclerosis: Protocol for a Pilot Study.
mHealth
mobile health
multiple sclerosis
patient-reported outcomes
remote monitoring
telemedicine
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
07 May 2021
07 May 2021
Historique:
received:
15
10
2020
accepted:
09
03
2021
revised:
09
02
2021
entrez:
7
5
2021
pubmed:
8
5
2021
medline:
8
5
2021
Statut:
epublish
Résumé
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. 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. 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. 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. 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. ClinicalTrials.gov NCT04555863; https://clinicaltrials.gov/ct2/show/NCT04555863. DERR1-10.2196/25011.
Sections du résumé
BACKGROUND
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
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
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
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
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
BACKGROUND
ClinicalTrials.gov NCT04555863; https://clinicaltrials.gov/ct2/show/NCT04555863.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/25011.
Identifiants
pubmed: 33960949
pii: v10i5e25011
doi: 10.2196/25011
pmc: PMC8140378
doi:
Banques de données
ClinicalTrials.gov
['NCT04555863']
Types de publication
Journal Article
Langues
eng
Pagination
e25011Informations de copyright
©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.
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