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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Recruiting
Amager Hvidovre Copenhagen Univerity Hospital
Copenhagen, Hvidovre, 2650
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 group | Role | What they receive |
|---|---|---|
| Family intervention group | Experimental | The 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 group | No intervention | The 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.
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)
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
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
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
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.
- First posted18 Nov 2019
- Study start1 Jan 2020
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stine Rosenstrøm, Copenhagen University Hospital, Hvidovre
- Investigators
- Stine Rosenstrøm, MHSc, Principal investigator, Copenhagen University Hospital, Hvidovre
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family Focused Nursing Intervention for Patients With Atrial Fibrillation - Effect of Group Education and Family Strength Orientated Therapeutic Conversations
- ClinicalTrials.gov ID
- NCT04165421
- Acronym / sponsor ID
- AFFINE / H19007769
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family intervention group | Experimental | Behavioral: Family intervention groupThe 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 |
| Control group | No intervention | –The 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with chronic heart failure according to international guidelines
- Patients not cable to cooperate about the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family intervention groupEducation and Family conversations | Behavioural | Family intervention group |
Primary outcome
Change in quality of life between baseline and follow-up at 6 months
Time frame: baseline and after 6 months
The Atrial Fibrillation Effect on QualiTY-of-Life (AFEQT) Questionnaire
4 secondary outcomes
Change in anxiety and depression between baseline and follow-up at 6 months
Time frame: baseline and after 6 months
Change in Family functioning between baseline and follow-up at 6 months
Time frame: baseline and after 6 months
Change in Family perceived support between baseline and follow-up at 6 months
Time frame: baseline and after 6 months
number of Hospital admissions between baseline and follow-up
Time frame: At follow-up 6 month after basline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stine Rosenstrøm, MHSc principal investigator
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
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.