JMIR Publications

ABSTRACT

Background:

The BETACONNECT autoinjector and myBETAapp app were designed to support patients with multiple sclerosis (MS) receiving interferon beta-1b treatment, and are also an ideal platform for digital observational studies. A recent pilot study in Germany demonstrated the feasibility of using the app to recruit patients, obtain informed consent, and evaluate medication-taking behavior over 6 months.

Objective:

Our aim was to use the app to investigate medication-taking behavior over 1 year in patients with MS receiving interferon beta-1b and to provide additional information on patient-reported outcomes (PROs). Optional use of the cognitive training tool PEAK (Peak, formerly Brainbow Ltd) was included to test the feasibility of gamification in this setting.

Methods:

A prospective and retrospective, digital, observational cohort study was conducted among users of the app in Germany. Invitations to participate were sent to patients’ apps during February-May 2019. Participants provided electronic informed consent. Injection-related data from consenting patients' devices were collected prospectively for 1 year following the consent date and retrospectively for ≤1 year from the first day of usage (if historical data were available). Participants also completed three PRO instruments every 3 months: the 5-dimension, 5-level EuroQol questionnaire (EQ-5D-5L); the Treatment Satisfaction Questionnaire for Medication version II (TSQM v. II); and a questionnaire on satisfaction with treatment support (on an electronic data capture server accessed via a hyperlink sent by email). All patients were offered optional access to the professional version of PEAK. Statistical analyses were exploratory and descriptive.

Results:

Of 1778 registered app accounts (May 2019), 79 patients (4.4%) provided informed consent and 62 were eligible for inclusion in the prospective analysis (60 of whom also had retrospective data). The mean age of the 62 participants was 43.2 years, and 41 (66%) were female. Compliance over the 1-year prospective observational period (primary endpoint) was high (median 98.9%) and similar among men and women. Persistence and adherence (coprimary endpoints) decreased from 85% (53/62) and 74% (46/62), respectively, at 6 months to 76% (47/62) and 65% (40/62), respectively, at 12 months; both were higher in men than in women. The retrospective analysis showed similar patterns. The PRO questionnaires were each answered by 79% (49/62) of the participants at baseline and 50% (31/62) at month 12. Women had more severe problems in some EQ-5D-5L dimensions (mobility, usual activities, and pain/discomfort) and lower median TSQM v. II convenience scores than men. At month 12, 84% (26/31) of the patients were satisfied or very satisfied with the app. PEAK was used at least once by 67% (14/21) of men and 49% (20/41) of women.

Conclusions:

This study demonstrated the feasibility of including remotely completed electronic PRO instruments in digital observational studies, in addition to reliably recording medication-taking behavior for ≤1 year. Clinical Trial: ClinicalTrials.gov NCT03808142; https://clinicaltrials.gov/ct2/show/NCT03808142