Telephone follow‑up by headache nurses versus standard care regarding adherence to preventive treatment: an open-label randomized trial

Objectives: We hypothesized that the proportion of patients who used preventive medication for at least two months would be higher in the nurse intervention group than in the standard-of-care (SOC) group.   Background: There is a lack of randomized studies evaluating the usefulness of headache nurse in the follow-up of patients who start preventive headache medication.  Methods: In this prospective, open-label, multicentre, two-armed parallel-group, superiority randomized controlled trial, participants were included in the period between April 2023 and November 2025. Patients with headache who were assessed at neurological outpatient clinics at three university hospitals were eligible for inclusion if they had a primary headache diagnosis and were prescribed preventive treatment. Patients who agreed to participate were randomized to either two telephone calls with a headache nurse (nurse intervention group) or follow-up by the SOC group. Both groups were offered a follow-up consultation with a headache doctor after approximately three months.  Results: After including the first 147 patients, the interim analyses showed a higher proportion of patient adherent to their preventive medication in the SOC group (65/71=92%, 95% CI 82-97%) than in the nurse intervention group (50/68=74%, 95% CI 61-83%)(p=0.005) after 2 months. For all secondary endpoints, similar results between the two groups were found  including for ≥ 50% headache response rate with 20% (95% CI 12-31%) in the SOC group and 13% (95% CI 7-24%) in the nurse intervention group, p=0.304), and for the treatment satisfaction with 62% (95% CI 50-73%) vs. 53% (95% CI 41-65%) (p=0.282).  Conclusions: The interim analyses in this randomized trial on patients with primary headaches who start preventive medication, showed that 92% in the standard-of-care group was adherent to their preventive medication. It is unlikely than inclusion of more participants would have demonstrated benefit of additional telephone calls from a headache nurse. Based on ethical considerations, the study was terminated before reaching the planned sample size of 400 participants.  Trial registration: Registered in clinicalTrials.gov (NCT06200480) (Study Details | NCT06200480 | Nurse Intervention Trial | ClinicalTrials.gov) December 14, 2023.