Medication Overuse Headaches: the Impact of Educative Telephone Coaching Administered by Nurses Prior to the Medical Appointment in a Tertiary Consultation Center: a Comparative Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy of educative telephone coaching administered by the center's nurses prior to the medical on-site visit.
研究概览
简要总结
In patients with MOH, we will evaluate the impact of educative telephone coaching on the number of days with headache over the month preceding the appointment. The educative coaching will be administered by a nurse, during a single phone call and prior to the medical visit
详细描述
In tertiary centers, it is not unusual for patients to wait for 6 months for a medical appointment. This clinical trial is monocentric, open, randomised. In the first arm, the patients will receive educative telephone coaching at Month 2 by the nurses, over the phone. In the second arm, the patients will not receive any educative telephone coaching before the appointment with the neurologist.
All patients will complete "Quality of life" questionnaires at Month 1 and Months 6, complete a migraine agenda during the length of the study and have a medical appointment around Month 6.
The primary outcome will be the efficacy of such educative telephone coaching, administered before the medical appointment in the Chronic Pain Center, in Bordeaux. It will be measured by the number of days with headache over the month preceding the appointment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, male or female, > 18 years old
- •Patients with a presumptive medication overuse headache diagnostic (>15 days/month with migraines, > 10 days/month intake of crisis treatment)
- •Persons calling the Chronic Pain Center in Bordeaux and asking for a medical appointment
- •Informed and written consent, dated and signed by the patient and the investigator prior to any study related procedure
排除标准
- •Patients with a differential diagnostic (other primitive headaches and secondary headaches)
- •Persons non affiliated to a social security system
- •Persons who refuse to participate in the study.
研究组 & 干预措施
2
no educative telephone coaching (ETC)
1
with educative telephone coaching (ETC)
干预措施: educative telephone coaching (ETC) (Behavioral)
结局指标
主要结局
To evaluate the efficacy of educative telephone coaching administered by the center's nurses prior to the medical on-site visit.
时间窗: within 6 months
次要结局
- To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC(within 6 months)
- To evaluate the efficacy of educative telephone coaching (ETC) on the frequency of headaches and on the number of days with crisis treatment intake.(within 6 months)
- To evaluate the efficacy of ETC on the patients quality of life and their handicap (emotional, professional and familial data)(within 6 months)
- To evaluate the patient's satisfaction toward ETC(within 6 months)
- To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment.(within 6 months)