NCT04165421

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

November 1, 2019

Last Update Submit

January 21, 2020

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

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

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

    baseline and after 6 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

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

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).

Interventions

Family intervention groupBEHAVIORAL

Education and Family conversations

Family intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amager Hvidovre Copenhagen Univerity Hospital

Copenhagen, Hvidovre, 2650, Denmark

RECRUITING

Study Officials

  • Stine Rosenstrøm, MHSc

    Copenhagen University Hospital, Hvidovre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stine M Rosenstrøm, MHSc

CONTACT

+45 38623711stine.maria.rosenstroem@regionh.dk

Anne B Madsen, PhD

CONTACT

+45 38623129anne.brødsgaard.madsen@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN,MHSc,PhD-student

Study Record Dates

First Submitted

November 1, 2019

First Posted

November 18, 2019

Study Start

January 1, 2020

Primary Completion

January 31, 2021

Study Completion

July 31, 2021

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)