The POPPINS-02-b follow-up study consists in following up patients who took part in the
POPPINS-02 clinical trial: a randomized non-inferiority trial with a control group
designed to assess the effect of adding the Poppins Clinical digital medical device to
reduced conventional care (one speech therapy session every two weeks) on the skills of
patients with reading disorders. Patients included in the original POPPINS-02 study were
randomized into one of two groups:
Experimental group (EXPE group): will receive the Poppins Clinical digital medical
device in addition to reduced conventional treatment (one speech therapy session
every two weeks).
Control group (CONT group): will receive conventional treatment only (one speech
therapy session per week).
In the original POPPINS-02 study, the experimental phase lasts 12 weeks in total, with a
preliminary evaluation (T1) and a final evaluation (T2) after this period.
All patients enrolled in the POPPINS-02 study will be included, if they so wish, in the
POPPINS-02-b follow-up study. This study consists of a 12-week follow-up phase after the
final POPPINS-02 protocol visit (T2). During this follow-up phase, all patients will
return to their usual speech therapy management with the frequency planned before their
participation in POPPINS-02. During this follow-up phase, patients in both groups will
not have access to the Poppins Clinical application. At the end of the 12-week follow-up
period, an evaluation (T3) is scheduled. Assessments will cover primary, secondary and
exploratory endpoints.
A questionnaire will also be submitted to parents and speech therapists caring for the
children during T3 in order to collect information on the dates of speech therapy
sessions during this follow-up period, and to benefit from their perspective on the
medium-term effect of the study protocol on speech therapy follow-up.
Access to the Poppins Clinical digital medical device will be offered to children in the
two POPPINS-02 study groups who decide to participate in the POPPINS-02-b follow-up study
at the end of the experiment.
The investigator and his team will remain blind as to which groups will be assigned to
the POPPINS-02 study.