Study of Management and Coaching in Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52
研究概览
简要总结
The purpose of this study is to evaluate the effect of a cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives.
详细描述
A randomized controlled design with pre- and 12 month posttest including persons living with atrial fibrillation and their relatives.
The distress management program (cognitive behavioral therapy) delivered in groups by a specialistnurse, a pedagogue and a cardiologist all trained in the distress management program. The program delivered to participants into three group- sessions extensive two hours each during a five weeks period 2011-2013.
Eligible participants were all consecutive identified when discharge after hospital care due to atrial fibrillation. The random process were managed by an open-label computer as block - randomization. Participants were enrolled and randomized during 2011-2013 into two arms; either to an experiment group to the distress management program or the control group. The trial, run alongside the standard care all of the participants received at a cardiology unit in a county hospital. The standard care was required to following actual guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Patients diagnosed with atrial fibrillation.
- •Relative to patient with atrial fibrillation.
- •To be over 18 years old .
排除标准
- •Unwillingness to participate in the study.
- •Other complicating illness'.
- •Language difficulties that prevent answering surveys.
- •Participation in another study.
- •Accommodation outside the hospital's catchment area.
研究组 & 干预措施
Distress management
The distress management program (cognitive behavioral therapy) alongside standard care
干预措施: A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives (Behavioral)
Control
Controls only dilivery standard care
结局指标
主要结局
Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52
时间窗: baseline and after 12 months
Change from baseline in self-rated sense of coherence (13-item); The sense of coherens scale, SOC 13-item at week 52.
时间窗: baseline and after 12 months
Changes from baseline in self-rated Health related quality of Life (36 item); The SF 36 - item short-form health status survey at week 52
时间窗: baseline and after 12 mounth
次要结局
- Changes from baseline in self-rated Health related quality of life (5 item); EuroQol Five Dimensions, EQ-5D at week 52(baseline and after 12 months)
研究者
Helena Ekblad
RN, BSC, PhD-student
Region Jönköping County