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临床试验/NCT04165421
NCT04165421Unknown不适用

A Family Focused Nursing Intervention for Patients With Atrial Fibrillation - Effect of Group Education and Family Strength Orientated Therapeutic Conversations

Copenhagen University Hospital, Hvidovre2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
Change in quality of life between baseline and follow-up at 6 months

研究概览

简要总结

Atrial fibrillation (AF) is a major and rapidly growing cardiac disease characterized by irregular heart rhythm. Living with AF can lead to stress, anxiety and depression for both patients and their families with increased risk of lost working days, hospitalization, and worsening of the disease. However, family-focused nursing has shown to capture the family's feelings and this could change the negative circle into a positive circle.

The study aim is to examine how families experience living with a family member with AF and if family involvement through a family focused nursing intervention and group education can improve quality of life for AF patients.

Family unit interviews, a study with focus group interviews with family members, and a randomized fidelity study evaluating the effect of the family focused nursing intervention will provide evidence-based knowledge on how to implement family focused nursing into care of patients with AF.

详细描述

Atrial fibrillation (AF) is the most common cardiac arrhythmia and it is a rising problem for patients in Western countries. AF is a costly public health problem with hospitalizations as the primary expenditure. The disease and treatment is complex and requires a high degree of patient adherence to prevent complications (stroke and major bleedings) and the burden of symptoms due to irregular heartbeat often leads to poor health related quality of life. Consequences of AF also often lead to impairment of physical functioning and mental health.

When illness is considered a family affair it is important for patients and their families to have a chance to talk about issues of hope, suffering and coping. A family will need support and solutions when successfully adjusting to having a family member with a chronic illness. Little is known about how families experience habituate life with AF, their concerns and feelings and their needs for support. FFN based on The Calgary Family Assessment model (CFAM) and the Calgary Family Intervention Model (CIFM) used as a theoretical model have been shown to be effective in family focused nursing interventions supporting patients and families in adjusting to life whit a disease. The effect of these models have never been tested in nursing interventions towards patients with AF and their families.

The aim of the study is to examine how AF- patients and families are influenced by AF and to test if involving family members in a FFN intervention with group education improves outcomes for patients with AF.

The study will consist of three sub-studies:

A phenomenological qualitative explorative study with family unit interviews, a study of focus group interviews with members of the family analyzed with content analysis, and a quantitative fidelity study (n=100/50 in standard care/50 in the intervention group) evaluating the effect of a family focused nursing intervention with improvement of quality of life living with AF as the primary outcome. Relevant statistical analyzes will be used.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Men and women > 18 years old with newly diagnosed AF (< 6 months since diagnose) documented in the patient file and verified by a EKG.
  • Family members must be > 18 years old and defined by the patient: e.g. spouse, son, daughter, near friend or neighbor.

排除标准

  • Patients with chronic heart failure according to international guidelines
  • Patients not cable to cooperate about the project

结局指标

主要结局

Change in quality of life between baseline and follow-up at 6 months

时间窗: baseline and after 6 months

The Atrial Fibrillation Effect on QualiTY-of-Life (AFEQT) Questionnaire

次要结局

  • Change in anxiety and depression between baseline and follow-up at 6 months(baseline and after 6 months)
  • Change in Family functioning between baseline and follow-up at 6 months(baseline and after 6 months)
  • Change in Family perceived support between baseline and follow-up at 6 months(baseline and after 6 months)
  • number of Hospital admissions between baseline and follow-up(At follow-up 6 month after basline)

研究者

发起方
Copenhagen University Hospital, Hvidovre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stine Rosenstrøm

RN,MHSc,PhD-student

Copenhagen University Hospital, Hvidovre

研究点 (2)

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