Digital-technology Based Interventions on Treatment of Migraine.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- headache frequency
研究概览
简要总结
The main aim of the research: To develop an interdisciplinary treatment platform based on digital technology and test the operation and effectiveness of digital interventions in comparison with conventional multidisciplinary treatment or treatment standards (incl. Paper diary, nurse counseling, physiotherapy, cognitive-behavioral therapy).
详细描述
Aims and purpose:
The main aim of the research: To develop an interdisciplinary treatment platform based on digital technology and test the operation and effectiveness of digital interventions in comparison with conventional multidisciplinary treatment or treatment standards (incl. Paper diary, nurse counseling, physiotherapy, cognitive-behavioral therapy).
Sub-aims:
To evaluate the effectiveness of interventions based on digital technology and their impact on the quality of life, comparing them with the interventions or treatment standards performed by ordinary specialists.
Assess the applicability and accessibility of digital technology-based interventions in the healthcare system against a treatment standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed migraine, frequent episodic, headache days a month 8-14 days;
- •patient age 18-64 years;
- •very good command of the Estonian language both orally and in writing.
排除标准
- •headaches lasting less than 8 days and more than 14 days per month;
- •all other primary and/or secondary diagnoses of headache;
- •under the age of 18 or over 64;
- •currently severe depression;
- •psychotic disorders;
- •pregnancy and lactation;
- •severe somatic disease;
- •severe organic mental disorders;
- •other chronic pain;
- •addictive disorders.
结局指标
主要结局
headache frequency
时间窗: 9 months
headache diary: number of headache days per month
次要结局
- Patient's willingness to pay for headache treatment(9 months)
- medication use(9 months)
- Patient satisfaction with treatment 1(3 months)
- Pain-related anxiety(9 months)
- Patient satisfaction with treatment 2(3 months)
- Patient satisfaction with treatment 3(6 months)
- Patient satisfaction with treatment 4(6 months)
- Patient satisfaction with treatment 5(9 months)
- Cost-effectiveness 2(9 months)
- The effect of headaches on everyday life(9 months)
- Health related quality of life(9 months)
- Cost-effectiveness 1(9 months)
- Pain acceptance Pain acceptance Pain acceptance(9 months)
- Patient satisfaction with treatment 6(9 months)