Facilitators and Barriers to Eptinezumab Administration in Thailand: Real-World Experiences and Perspectives From Mixed-method Design and In-Depth Interviews (FACEpi)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Migraine patients' experiences after receiving eptinezumab
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
People with episodic or chronic migraine who have NEVER received CGRP mAb therapy
Patients who were diagnosed migraine with or without aura or chronic migraine and have NEVER received eptinezumab.
Inclusion
- Age ≥ 18 years
- Diagnosed with migraine with or without aura or chronic migraine according to the ICHD-3
- Have received eptinezumab infusion at KCMH
- Have NEVER received any CGRP mAbs prior to starting eptinezumab
- Able to communicate in Thai fluently
- Provide informed consent
Exclusion
- Participants who cannot completely participate in an in-depth interview and questionnaires, either in-person or online
- Participants with headache disorders other than migraine with or without aura or chronic migraine
- Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
- A known history of allergy to eptinezumab
干预措施: Eptinezumab (Drug)
People with episodic or chronic migraine who have received CGRP mAb therapy
Patients who were diagnosed migraine with or without aura or chronic migraine and have received eptinezumab.
Inclusion
- 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 received other CGRP mAbs prior to starting eptinezumab
- Able to communicate in Thai fluently
- Provide informed consent
Exclusion
- Participants who cannot completely participate in an in-depth interview (IDI) and questionnaires, either in-person or online
- Participants with headache disorders other than migraine with or without aura or chronic migraine
- Alcohol or drug use that, in the opinion of the investigator, would interfere with completion of study procedures
- A known history of allergy to eptinezumab
干预措施: Eptinezumab (Drug)
Healthcare Provider
Healthcare providers (e.g. doctor, outpatient nurse and daycare nurse) who are responsible for providing eptinezumab to the patients.
Inclusion criteria
- Age ≥ 18 years
- Currently working at KCMH
- Have been working at KCMH for more than 3 months
- Involved in providing care to patients attending the Headache Clinic
- Able to communicate in Thai fluently
- Provide informed consent
Exclusion criteria
1. Participants who cannot completely participate in an IDI, either in-person or online
干预措施: Sham (No Treatment) (Other)
结局指标
主要结局
Migraine patients' experiences after receiving eptinezumab
时间窗: At enrollment (witihin 24 hours of receiving eptinezumab) and 3 months follow-up
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
Facilitators and barriers of integrating the use of eptinezumab in the headache specialty clinic in Thailand from the perspective of migraine patients
时间窗: At enrollment (witihin 24 hours of receiving eptinezumab) and 3 months follow-up
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?
Facilitators and barriers of integrating the use of eptinezumab in the headache specialty clinic in Thailand from the perspective of healthcare providers
时间窗: At enrollment (witihin 24 hours of giving eptinezumab administration)
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
次要结局
- Changes in monthly migraine days (MMD)(At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up)
- Changes in Migraine Disability Assessment (MIDAS) Score(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))(At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up)
- Changes in abortive medication use(At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up)
- Change in preventive medication use(At enrollment (witihin 24 hours of receiving eptinezumab), 3 months follow-up, and 6 months follow-up)
研究者
Thanakit Pongpitakmetha, MD, MSc
Lecturer
Chulalongkorn University