10-year Follow-up After 24/7-phone Support After Aortic Valve Replacement Surgery in Early Rehabilitation Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 282
- 主要终点
- Symptoms of anxiety and depression
研究概览
简要总结
There is a lack of data on patients self-reported outcomes (PROMs) on health-related quality of life (HRQoL)and symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient reported experiences with the health services (PREMS). In this 10-years follow-up study on patients alive from the study named "The Impact of 24/ 7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial (AVRre)" NCT02522663 we will repeat the survey on symtoms on anxiety and depresion using Hospital Anxiety and depression Scale (HADS), health-related quality of life (EQ-5D) and questions about experiences with the health services.
详细描述
"The Impact of 24/ 7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial (AVRre) was a prospective, randomized controlled study (RSC) Including 286 patients after AVR from 2015 til 2017, NCT02522663. The results reported in international publications showed reduced symptoms on anxiety the first month after AVR.
Reduction of anxiety revealed to be an important aim for the intervention. We found that symptoms of anxiety in the early rehabilitation phase after discharge following surgical aortic valve replacement phase was significantly reduced.
There is a lack of data on patients self-reported outcome on symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient reported experiences with health services. In this 10-years follow-up study on patients alive from the study named "The Impact of 24/ 7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial (AVRre)" NCT02522663 we will conduct a survey on symtoms of anxiety and depresion using Hospital Anxiety and depression Scale (HADS), quality of life (EQ-5D) and questions about experiences with health services.
The results of the planned 10-years follow-up may give guidance in how to allocate health resources and planning for and follow-up of patients after heart surgery.
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
- 否
入选标准
- •Treatment with AVR (biological or mechanical) single, AVR (b or m)+aortocoronary bypass, AVR (b or m)+supra coronary tube graft Can understand, speak and write native Language (norwegian), and be able to fill in the questionnaires
排除标准
- •Patients not alive after the AVRre study
结局指标
主要结局
Symptoms of anxiety and depression
时间窗: 10 year follow-up
Symptoms of anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)
Health related quality of life
时间窗: 10 year follow-up
EQ-5D-3L questionnaire from The EuroQol Group to measure health related quality of life.
次要结局
- Experiences with health services(10 year follow-up)
研究者
Stein Ove Danielsen
Associate professor
Oslo University Hospital