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: * What are the barriers and facilitators to using eptinezumab from the perspectives of patients and healthcare providers? * Does eptinezumab reduce monthly migraine days and improve quality of life over time? Participants will: * (For migraine patients) Take part in an in-depth interview (IDI) within 24 hours after receiving an eptinezumab infusion * (For migraine patients) Complete questionnaires about migraine symptoms, disability, and quality of life at baseline, 3 months, and 6 months * (For healthcare providers) Take part in a one-time interview about their experiences administering eptinezumab 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: * To understand what helps or makes it hard to use eptinezumab in real-world practice * To see if eptinezumab helps reduce migraine days and improve quality of life 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.
Study Type
OBSERVATIONAL
Enrollment
30
Eptinezumab 100 mg IV q 3 months * Baseline visit: Within 24 hours of receiving eptinezumab (duration of IDI \~30 - 45 minutes) * Semi-structured In-depth interview * MMD (days) * Thai version MIDAS (total score, grading) * Thai version EQ-5D-5L (5 domains \& 5 levels of severity; index score) * 3-month follow-up visits (duration of interview: \~10 minutes): * Semi-structured brief interview * MMD (days) * Thai version MIDAS (total score, grading) * Thai version EQ-5D-5L (5 domains \& 5 levels of severity; index score) * 6-month follow-up visit: * no interview * MMD (days) * Thai version MIDAS (total score, grading) * Thai version EQ-5D-5L (5 domains \& 5 levels of severity; index score)
\*\* No intervention, neither eptinezumab nor placebo, was given * Baseline visits: Within 24 hours of giving eptinezumab administration (duration of IDI \~30 - 45 minutes) - Semi-structured in-depth interview
King Chualongkorn Memorial Hospital, the Thai Red Cross Society
Bangkok, Thailand
Migraine patients' experiences after receiving eptinezumab
Group 1 (People with migraine with or without aura or chronic migraine): 1. Baseline visit at the time of enrollment. \- A semi-structured IDI will be conducted within 24 hours of receiving eptinezumab. 2. 3-month follow-up visit: * Participants will complete a set of questionnaires to assess their experiences after receiving eptinezumab infusion * A brief semi-structure interview 3. 6-month follow-up visit: * No interview
Time frame: At enrollment (witihin 24 hours of receiving eptinezumab) and 3 months follow-up
Facilitators and barriers of integrating the use of eptinezumab in the headache specialty clinic in Thailand from the perspective of migraine patients
Group 1 (People with migraine with or without aura or chronic migraine) * Baseline visit: Within 24 hours of receiving eptinezumab \- Semi-structured IDI (duration of IDI \~30 - 45 minutes) * Satisfactory, acceptance, adaptability, feasibility, cost of eptinezumab administration * Patients' migraine symptoms and their impact on daily life, emotional well-being, and social well-being. * The perspective of oral and non-oral form of prevention medicine * Patients' experiences of migraine symptom improvement and the wearing-off effect during prior anti-CGRP injections in the group with previously failed anti-CGRP treatments. * Patients' migraine symptoms between administration of eptinezumab * 3-month follow-up visits (duration of interview: \~10 minutes) * Brief interview (duration of interview: \~10 minutes) * What are your thoughts on eptinezumab infusion? * What is the difference between prior anti-CGRP treatments and eptinezumab in prior anti CGRP group?
Time frame: At enrollment (witihin 24 hours of receiving eptinezumab) and 3 months follow-up
Facilitators and barriers of integrating the use of eptinezumab in the headache specialty clinic in Thailand from the perspective of healthcare providers
Group 2 (Healthcare providers) o Baseline visits: Within 24 hours of giving eptinezumab administration (duration of IDI \~30 - 45 minutes) \- Semi-structured IDI exploring facilitators and barriers of integrating the use of eptinezumab in the headache specialty clinic in Thailand
Time frame: At enrollment (witihin 24 hours of giving eptinezumab administration)
Changes in monthly migraine days (MMD)
Group 1 (People with migraine with or without aura or chronic migraine) Monthly migraine days are measured by patient self-report or headache diary review by investigators.
Time frame: At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up
Changes in Migraine Disability Assessment (MIDAS) Score
The MIDAS score is a validated questionnaire used to quantify migraine-related disability over the past 3 months. It consists of five main items assessing the number of days of activity limitation due to migraine in three domains: work/school, household chores, and social/leisure activities. Scoring The total MIDAS score (Minimum value: 0 Maximum value: 270 Higher scores mean a worse disability) is calculated by summing responses to the five main items (each answered as the number of days affected). Disability Severity Grading: * Grade I (0-5): Little or no disability * Grade II (6-10): Mild disability * Grade III (11-20): Moderate disability * Grade IV (21+): Severe disability Two additional questions assess number of headache days per 3 months and average headache pain intensity (on a scale of 0-10), but these do not contribute to the total score. Thai MIDAS version was applied and administered by trained investigators https://doi.org/10.31524/bkkmedj.2018.02.003
Time frame: At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up
Changes in Quality of Life (EuroQoL (EQ-5D-3L))
Quality of life as measured by the Thai version of the EQ-5D-5L questionnaire. The raw scores were transformed to utility scores for Thai population as previously suggested (Pattanaphesaj J., 2018). Structure The EQ-5D-3L includes: * Five dimensions: 1. Mobility 2. Self-care 3. Usual activities 4. Pain/discomfort 5. Anxiety/depression Each dimension has three levels: * No problems (Level 1) * Some problems (Level 2) * Extreme problems (Level 3) The combination of levels across dimensions defines a unique health state (e.g., 11223). A total of 243 health states are possible. Scoring * Each health state is converted into a single index value (utility score) using a Thai-specific value set. * Utility scores typically range from -0.452 to 1.000, where: * 1.000 = full health * 0 = death * \<0 = states perceived worse than death
Time frame: At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up
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Changes in abortive medication use
Abortive medication use is reviewed by patient self-report and rechecked with the electronic medical record information by investigators Data collection * Generic name * Dosage (mg) * Number of pills used per month
Time frame: At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up
Change in preventive medication use
Preventive medication use is reviewed by patient self-report and rechecked with the electronic medical record information by investigators Data collection * Generic name * Dosage (mg) * Number of pills used per month
Time frame: At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up