To provide a rationale and pilot study protocol for a mobile health solution named “haMSter” that allows for remote monitoring of patient reported outcomes in people with multiple sclerosis (pwMS).

Treatment and monitoring decisions in people with multiple sclerosis (MS) are based commonly on clinician reported outcomes (CROs). These reflect physical and radiological disease activity and are the most relevant endpoints in clinical trials. Complementing CROs, the number of studies evaluating patient reported outcomes (PROs) has been increasing. The emergence of PROs has made a tremendous contribution to understanding the individual impact of disease in pwMS and their health-related quality of life. However, the assessment of PROs consumes significant resources of time and personnel. Thus, useful ways to conveniently introduce them into clinical practice are needed.

The core function of haMSter is the provision of three scientifically validated PROs relevant to MS for patients to fill out at home once a month. These include the Hospital Anxiety and Depression Scale (HADS), the Multiple Sclerosis Impact Scale (MSIS-29), and the Fatigue Scale for Motor and Cognitive Function (FSMC). Through the use of the haMSter app, longitudinal and remote measurement of validated PROs is enabled. A scoring algorithm graphically plots PRO scores over time and makes them available at the next visit to be discussed with the treating neurologist.

A pilot study is currently ongoing and will evaluate adherence to this m-health solution as a primary endpoint in 50 patients using haMSter over a period of six months. Recruitment began in April 2020 and was closed in October 2020.

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