Future Patient - Telerehabilitering af Patienter Med Atrieflimren (FP-AF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Changes in AF specific health-related quality of life
研究概览
简要总结
This project has focus on patients with atrial fibrillation testing a telerehabilitation program for patients with atrial fibrillation.
详细描述
The overall aim of the FP-AF program is to increase quality of life by giving the patients and relatives more knowledge about atrial fibrillation, its symptoms, and the issues of living with atrial fibrillation in everyday life. The specific aims are to individualize the rehabilitation process and help the patients and relatives develop their own self-management strategies using their own clinical data and their enhanced knowledge about AF.
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
- 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
- •Patients diagnosed with atrial fibrillation
- •Adults over 18 years
- •Living in Skive, Viborg or Silkeborg Municipalities
- •Living at home and capable of caring for themselves
- •Have basic computer skills or having a relative/friend with basic computer skills
排除标准
- •Pregnancy
- •Refusal or inability to cooperate; or patient not does not speak, read or understand Danish
- •Life expectancy less than a year
结局指标
主要结局
Changes in AF specific health-related quality of life
时间窗: For both intervention and control group: QoL will be measured at baseline, end of telerehabilitation (16 weeks) and after 28 weeks
The Atrial Fibrillation Effect on quality of life questionnaire (AFEQT) is a 20-item self-administered questionnaire designed to assess the impact of AF on the patients' health-related quality of life (HRQoL) across symptoms, daily activities, treatment concerns, and treatment satisfaction. Scores range from 0-100, with higher scores indicating better HRQoL
次要结局
- Measurement of bloodpressure(Intervention group: Bloodpressure will be measured at baseline, twice a week, and as needed up to 16 weeks)
- Measurement of heart rhythm(Intervention group: ECG wil be measured at baseline, twice a week, and as needed up to 16 weeks)
- Measurement of sleep(Intervention group: Sleep will be measured every day up to 16 weeks)
- Patients' and relatives' expectations for and experiences with participation in the tele-rehabilitation program (including the Heartportal)(Intervention group: Interviews at end of telerehabilitation (16 weeks) and logfiles and observation at end follow up (28 weeks))
- Changes in AF knowledge(For both intervention and control group: To be measured at baseline, end of telerehabilitation (16 weeks) and after 28 weeks)
- Changes in anxiety and depression(Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.)
- Measurement of steps(Intervention group: Steps will be measured from the date of randomization, everyday to end follow up (28 weeks))
- Burden of AF(Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.)
- Measurement of weight(Intervention group: Weight will be measured at baseline, twice a week, and as needed up to 16 weeks)
- Measurement of pulse(Intervention group: Pulse will be measured at baseline, everyday, and as needed up to 16 weeks)
- Cost-effectiveness analysis of the FP-AF telerehabilitation program compared to conventional care(Both intervention and control group: At the end of telerehabilitation (16 weeks) and at end follow up (28 weeks))
- Future governance and infrastructure for telerehabilitation of AF patients(Intervention group: At the end of telerehabilitation (16 weeks))
- Changes in motivation(Both intervention and control group: At baseline, end of telerehabilitation (16 weeks) and after 28 weeks.)
- Healthcare professionals' experiences with workflows and collaboration with each other in the telerehabilitation program.(Intervention group: End of telerehabilitation (16 weeks))
- Patterns in multiparametric clinical monitoring(Intervention group: At the end of telerehabilitation (16 weeks).)
研究者
Birthe Dinesen
Professor
Aalborg University