Measuring the Effect of Person Centered, Nurse Led Care on Health-related Quality of Life in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Arrhythmia related quality of life measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)
研究概览
简要总结
The aim of the study is to evaluate the effect of a person-centred nurse-led outpatient clinic on health related quality of life, for persons with AF. Secondary outcomes are effects on anxiety, depression, illness perception, symtom burden, life style and health economics.
详细描述
The aim of the study is to evaluate the effect of a person-centred nurse-led outpatient clinic on health related quality of life, for persons with AF. Secondary outcomes are effects on anxiety, depression, illness perception, symtom burden, life style and health economics.
We plan a randomized controlled trial comparing person centred nurse led care vs. standard care. A sample size of 100 persons per group will be recruited.
Data will be collected through questionnaires, medical records, interviews.
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
- 否
入选标准
- •patients aged > 18 years with diagnosis of atrial fibrillation, referred for follow up after atrial fibrillation, able to provide informed consent and able and willing to fill in questionnaires.
排除标准
- •Atrial flutter diagnosis, Severe heart failure (corresponding to NYHA IIIB and NYHA IV), Cardiac surgery < 3 month prior to hospitalization for atrial fibrillation, planned surgical procedures (catheter ablation, cardiac surgery), Atrial fibrillation in connection with acute coronary syndrome or infection, not able to fill in questionnaires.
研究组 & 干预措施
Usual care
Participants in the usual care arm will receive care as usual, ie follow up by doctors after hospitalization for atrial fibrillation.
干预措施: Usual care (Other)
Nurse led person centred care
Participants in the nurse led, person centred care arm will receive person centred follow up after hospitalization for atrial fibrillation. The person centred care and usual care routines are provided by nurses.
干预措施: Nurse led person centred care (Behavioral)
结局指标
主要结局
Arrhythmia related quality of life measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)
时间窗: Baseline, 6 month and 1 year
Change from baseline in arrhythmia related quality of life, measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA), at six month and one year. ASTA is a validated questionnaire with a 13-item arrhythmia related quality of life scale. The scores for the total scale range between 0 and 39, with higher scores reflecting more negative effects on HRQoL.
Health related quality of life measured by EuroQol-5D (EQ-5D) questionnaire
时间窗: Baseline, 6 month and 1 year
Change from baseline in health related quality of life, measured by EuroQol-5D (EQ-5D) questionnaire at six month and one year. EQ-5D measure Health related quality of life with scores (5 items) and a scale (0-100).
次要结局
- Anxiety measured by Hospital Anxiety and Depression Scale (HADS)(Baseline, 6 month and 1 year)
- Lifestyle habits-smoking, measured by questionnaire,(Baseline, 6 month and 1 year)
- Quality-adjusted life years,(QALYs) gathered with EuroQol-5D (EQ-5D) questionnaire.(Baseline to 1 year)
- Depression measured by Hospital Anxiety and Depression Scale (HADS)(Baseline, 6 month and 1 year)
- Lifestyle habits-physical activity by questionnaire(Baseline, 6 month and 1 year)
- Symptom burden measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)(Baseline, 6 month and 1 year)
- Illness perception measured by Brief Illness Perception Questionnaire (B-IPQ)(Baseline, 6 month and 1 year)
- Lifestyle habits-diet by questionnaire(Baseline, 6 month and 1 year)
- Lifestyle habits-alcohol use by questionnaire(Baseline, 6 month and 1 year)