Quality of Life Clinical Trial
Official title:
A Family Focused Nursing Intervention for Patients With Atrial Fibrillation - Effect of Group Education and Family Strength Orientated Therapeutic Conversations
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.
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.
The two qualitative studies will gather new knowledge about families need of support which
will be used to shape the family focused intervention.
The study inclusion criteria are: Men and women > 18 years with newly diagnosed AF. Family
members who participate in interviews and in the intervention program are defined by the
patient: e.g. spouse, son, daughter, near friend or neighbor. Patients with heart failure
will be excluded.
The intervention begins with a two hour group session for AF-patients and family members
designed by the PhD student and the project nurses based on clinical guidelines of
AF-management and theory from multifamily group intervention. Project nurses who are also
Nurse specialists will facilitate knowledge to patients and family members about AF and how
to support self-management in their daily living. Furthermore the FFN intervention will
consist of 3 -5 Family Strength Orientated Therapeutic Conversations (FAM-SOTC) accordingly
to the needs of patient and the family. The FAM-SOTC conversations will be used as health
promoting conversations and a way to enhance family health and psychological resilense.
Before the FFN intervention the two project nurses and the PhD student will be trained
theoretically and practically in performing health promoting family conversations at Linné
University in Sweden.
It is expected that the study will provide a new understanding and evidence based knowledge
on how to incorporate a family focused intervention and education of patients with AF and
their families into the AF management and care.
In the future, results from the studies can be used to design a randomized controlled trial
which could determine the possibilities and limitations of a tailored health promotion
intervention for patients with AF.
The study is expected to be initiated in February 2019 and it will be completed in three
years.
The Danish Data Protection Agency and The Scientific Ethical Committee will be asked to what
degree the study has a duty to notify the agency.
Participants in the sub-studies will receive written and oral information about the project
and must give written informed consent regarding participation which they can retract at any
time. All data will be treated confidentially and anonymized. All data are stored securely
and locked in safe electronic files.
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