Flow of eligible participants for inclusion in intention-to-treat analysis in the randomized trial.
VIRUS DISEASE, RECRUITMENT
Our pre-study sample size calculation was done using the power-command in Stata. The analysis was based on the 13-item Patient Activation Measure (PAM-13) to detect a treatment effect of 7 points (0.5 SD) (with 80% power and a two-sided 0.05 significance level) yielded a sample size of 64 participants in each trial arm. To account for possible dropouts, we assumed an increase to 77 (20%) in each group to be appropriate. Our initial sample was not sufficient to fulfil this number and accordingly we recruited additional people scheduled for consultations in the four clinics to take part in the intervention. Because of restrictions imposed on access to primary care clinics after the start of the Corona Virus Disease 2019 (COVID-19) pandemic, the recruitment of additional patients had to be conducted in clinics that at this timepoint, were in a severe lock-down situation.After the intervention, a medical secretary, invited participants from the intervention group to participate in qualitative interviews. Inclusion criteria were participation in the 12-month follow-up and contributors from all sites. To balance the representation, both sexes and a variation in age were additional requirements.