Person Centered Nurse Led Atrial Fibrillation Care

Measuring the Effect of Person Centered, Nurse Led Care on Health-related Quality of Life in Patients With Atrial Fibrillation

The aim of the study is to evaluate the effect of a person-centred nurse-led outpatient clinic on health related quality of life, for persons with AF. Secondary outcomes are effects on anxiety, depression, illness perception, symtom burden, life style and health economics.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Behavioral: Nurse led person centred care; Other: Usual care

Detailed Description

The aim of the study is to evaluate the effect of a person-centred nurse-led outpatient clinic on health related quality of life, for persons with AF. Secondary outcomes are effects on anxiety, depression, illness perception, symtom burden, life style and health economics.

We plan a randomized controlled trial comparing person centred nurse led care vs. standard care. A sample size of 100 persons per group will be recruited.

Data will be collected through questionnaires, medical records, interviews.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Region Västerbotten
    • Umeå, Region Västerbotten, Sweden, 90185
      • Norrlands Universitetssjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients aged > 18 years with diagnosis of atrial fibrillation, referred for follow up after atrial fibrillation, able to provide informed consent and able and willing to fill in questionnaires.

Exclusion Criteria:

• Atrial flutter diagnosis, Severe heart failure (corresponding to NYHA IIIB and NYHA IV), Cardiac surgery < 3 month prior to hospitalization for atrial fibrillation, planned surgical procedures (catheter ablation, cardiac surgery), Atrial fibrillation in connection with acute coronary syndrome or infection, not able to fill in questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse led person centred care; Participants in the nurse led, person centred care arm will receive person centred follow up after hospitalization for atrial fibrillation. The person centred care and usual care routines are provided by nurses.	Behavioral: Nurse led person centred care; Person centred care include patiens narratives, partnership and documentation of a health plan.
Active Comparator: Usual care; Participants in the usual care arm will receive care as usual, ie follow up by doctors after hospitalization for atrial fibrillation.	Other: Usual care; Usual care provided by doctors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life measured by EuroQol-5D (EQ-5D) questionnaire	Change from baseline in health related quality of life, measured by EuroQol-5D (EQ-5D) questionnaire at six month and one year. EQ-5D measure Health related quality of life with scores (5 items) and a scale (0-100).	Baseline, 6 month and 1 year
Arrhythmia related quality of life measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)	Change from baseline in arrhythmia related quality of life, measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA), at six month and one year. ASTA is a validated questionnaire with a 13-item arrhythmia related quality of life scale. The scores for the total scale range between 0 and 39, with higher scores reflecting more negative effects on HRQoL.	Baseline, 6 month and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety measured by Hospital Anxiety and Depression Scale (HADS)	Change from baseline in anxiety, measured by Hospital Anxiety and Depression Scale (HADS) at six month and one year. HADS-anxiety ranges from 0 to 21; higher scores indicate higher anxiety complains.	Baseline, 6 month and 1 year
Depression measured by Hospital Anxiety and Depression Scale (HADS)	Change from baseline in depression, measured by Hospital Anxiety and Depression Scale (HADS), at six month and one year. HADS-depression ranges from 0 to 21; higher scores indicate higher depression complains.	Baseline, 6 month and 1 year
Symptom burden measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)	Change from baseline in symptom burden, measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA), at six month and one year. ASTA is a validated questionnaire with a 9-item symptom scale, each with a score of 0-4, The scores for the total scale range between 0 and 27, with higher scores reflecting higher symptom burden.	Baseline, 6 month and 1 year
Lifestyle habits-smoking, measured by questionnaire,	Change from baseline in lifestyle habits-smoking, measured by questionnaire (developed by The Swedish National Board of Health and Welfare), whether the patient is non smoker, prior smoker or current smoker (self-report), at six month and one year.	Baseline, 6 month and 1 year
Lifestyle habits-diet by questionnaire	Change from baseline in lifestyle habits-diet, measured by a questionnaire (developed by The Swedish National Board of Health and Welfare) with 5 items about eating habits, at six month and one year.	Baseline, 6 month and 1 year
Lifestyle habits-physical activity by questionnaire	Change from baseline in lifestyle habits-physical activity, measured by a questionnaire (developed by The Swedish National Board of Health and Welfare) with 2 items about physical activity habits, at six month and one year.	Baseline, 6 month and 1 year
Lifestyle habits-alcohol use by questionnaire	Change from baseline in lifestyle habits-alcohol use, measured by a questionnaire (developed by The Swedish National Board of Health and Welfare) with 3 items about alcohol use, at six month and one year.	Baseline, 6 month and 1 year
Illness perception measured by Brief Illness Perception Questionnaire (B-IPQ)	Change from baseline in illness perception, measured by Brief Illness Perception Questionnaire (B-IPQ) at six month and one year. B-IPQ measures illness perception and is a 9-item validated questionnaire. 8 items are scored 0-10, the 9th item is a question of cause and answering in text.	Baseline, 6 month and 1 year
Quality-adjusted life years,(QALYs) gathered with EuroQol-5D (EQ-5D) questionnaire.	Change from baseline in quality-adjusted life years (QALYs) at one year. The EuroQoL-5D-3L (EQ-5D) will be used for the quality of life dimension, while the time elapsed between each EQ-5D measurement will be considered for the time dimension.	Baseline to 1 year

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Karin H Ängerud, Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Estimated): July 10, 2025
• Study Completion (Estimated): July 10, 2025

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: atrial fibrillation; health related quality of life; person centred care; nurse led
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Flimmerstudie2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No