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Quality of LifeAFFINENCT04165421

Family Focused Intervention for Patients With Atrial Fibrillation

A study testing Family intervention group in people with Quality of Life, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Quality of Life
What is being tested?
Family intervention group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteDenmark
Study dates
1 Jan 2020to 31 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site, 1 recruiting
  • Amager Hvidovre Copenhagen Univerity Hospital

    Copenhagen, Hvidovre, 2650

    Recruiting

Other trials in Denmark

About this study

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.

Read the detailed description

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.

Conditions
Quality of Life
Being tested
Family intervention group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family intervention groupBehavioural

    Education and Family conversations

Study groups in NCT04165421
Study groupRoleWhat they receive
Family intervention groupExperimentalThe intervention starts 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 (Family focused nursing) 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
Receives: Behavioral: Family intervention group
Control groupNo interventionThe control group will receive conventional care and treatment according to guidelines. Conventional care is characterized by ad hoc management as per usual standards of clinical care (with access to routine medical care, hospital care, and pharmacotherapy).

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: baseline and after 6 months

Secondary outcomes (4)
  1. Change in anxiety and depression between baseline and follow-up at 6 months

    Hospital Anxiety Depression Scale (HADS) Questionnaire

    Measured: baseline and after 6 months

  2. Change in Family functioning between baseline and follow-up at 6 months

    Ice Expressive Family Functioning Questionnaire (ICE-EFFQ)

    Measured: baseline and after 6 months

  3. Change in Family perceived support between baseline and follow-up at 6 months

    Ice Family Perceived Support Questionnaire(ICE-FPSQ)

    Measured: baseline and after 6 months

  4. number of Hospital admissions between baseline and follow-up

    Self-reported

    Measured: At follow-up 6 month after basline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2019
  2. Study start1 Jan 2020
  3. Primary completion31 Jan 2021 (estimated)
  4. Study completion31 Jul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04165421
Sponsor's protocol ID
H19007769
Acronym
AFFINE
Status last verified
Jan 2020
First submitted
1 Nov 2019
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Family intervention group in people with Quality of Life, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Stine M Rosenstrøm, MHSc (+45 38623711, stine.maria.rosenstroem@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in quality of life between baseline and follow-up at 6 months (time frame: baseline and after 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.

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