Facilitators and Barriers to Eptinezumab Administration in Thailand: Real-World Experiences and Perspectives From Mixed-method Design and In-Depth Interviews (FACEpi)
Facilitators and Barriers to Eptinezumab Administration in Thailand: Real-World Experiences and Perspectives From Mixed-method Design and In-Depth Interviews (FACEpi)
This research study is designed as a longitudinal prospective descriptive study using mixed-method data collection. Eptinezumab, an anti-calcitonin gene-related peptide monoclonal antibody (anti-CGRP mAb), is administered by intravenous (IV) infusion every 3 months as preventive medication for individuals with migraine who have been diagnosed based on theInternational Classification of Headache Disorders, 3rd edition (ICHD-3) by headache specialist neurologists. The goal of this study is to understand the real-life experiences of people with migraine who receive eptinezumab in a hospital setting in Thailand, a middle-income country. The researchers want to learn about what makes it easier or harder for patients and healthcare workers to use this treatment.
The main questions it aims to answer are:
Participants will:
The study will also look at how well eptinezumab works by measuring changes in monthly migraine days and other health scores over a 6-month period. The information from this study may help improve migraine care in Thailand and support better access to new treatments like eptinezumab.
This study explores how people with migraine in Thailand experience treatment with eptinezumab, a anti-CGRP mAb given through an IV infusion every 12 weeks to help prevent migraine attacks. While this medicine may work quickly and avoid skin irritation from injections, it must be given at a hospital, which may cause challenges for patients and healthcare providers. These challenges can include travel, time, cost, or extra work for hospital staff.
The study, called FACEpi, will look at what makes eptinezumab easy or hard to use in real life. It will gather views from both people with migraine and the healthcare professionals who provide the treatment. Researchers want to better understand how patients feel about this treatment and how it affects their daily life.
About 30 participants will join the study from the Headache Clinic and Daycare Ward at King Chulalongkorn Memorial Hospital (KCMH). These include adults with migraine (10 participants who have never recieved anti-CGRP mAb and 10 participants who have recieved anti-CGRP mAb) and 10 healthcare providers including doctors, nurses, nurse aids, etc. who give eptinezumab in our hospital.
Each patient will take part in a semi-structured interview shortly after receiving eptinezumab and complete short surveys about migraine symptoms, migraine headache day (MHD), migraine disability (MIDAS), and quality of life (Euro-Quality of Life version EQ-5D-5L) at three time points: within 24 hours after treatment, after 3 months, and after 6 months. Healthcare providers will complete a one-time interview to talk about their experiences giving the treatment.
The main goals of this study are:
Data from interviews will be reviewed for common themes using special software. Outcome measures will be analyzed using standard statistical tools. The results of this study will help doctors and public health leaders understand how to make migraine treatment more accessible and effective for patients in Thailand.
Target Population
Group 1: Patients who were diagnosed migraine with or without aura or chronic migraine and have received eptinezumab.
Group 2: Healthcare providers (e.g. doctor, outpatient nurse and daycare nurse) who are responsible for providing eptinezumab to the patients.
Inclusion Criteria Group 1: People with migraine with or without aura or chronic migraine Inclusion criteria Group 1A
Age ≥ 18 years
Diagnosed with migraine with or without aura or chronic migraine according to the ICHD-3*
Have received eptinezumab infusion at the KCMH
Have NEVER received any CGRP mAbs prior to starting eptinezumab
Able to communicate in Thai fluently
Provide informed consent
* The diagnosis will be established by consensus between two headache specialists. In case of a discrepancy, conflicts will be resolved through a final consensus agreement between the two specialists prior to enrollment.
Group 2: Healthcare providers Inclusion criteria
Exclusion Criteria Group 1: People with migraine with or without aura or chronic migraine