Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04609202

Person Centered Nurse Led Atrial Fibrillation Care

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norrlands Universitetssjukhus

Umeå, Region Västerbotten, 90185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nurse led person centred care

Behavioral

Person centred care include patiens narratives, partnership and documentation of a health plan.

Usual Care

Other

Usual care provided by doctors

Primary outcomes

  1. Health related quality of life measured by EuroQol-5D (EQ-5D) questionnaire

    Time frame: Baseline, 6 month and 1 year

    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).

  2. Arrhythmia related quality of life measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)

    Time frame: Baseline, 6 month and 1 year

    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.

Secondary outcomes

  1. Anxiety measured by Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline, 6 month and 1 year

    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.

  2. Depression measured by Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline, 6 month and 1 year

    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.

  3. Symptom burden measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)

    Time frame: Baseline, 6 month and 1 year

    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.

  4. Lifestyle habits-smoking, measured by questionnaire,

    Time frame: Baseline, 6 month and 1 year

    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.

  5. Lifestyle habits-diet by questionnaire

    Time frame: Baseline, 6 month and 1 year

    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.

  6. Lifestyle habits-physical activity by questionnaire

    Time frame: Baseline, 6 month and 1 year

    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.

  7. Lifestyle habits-alcohol use by questionnaire

    Time frame: Baseline, 6 month and 1 year

    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.

  8. Illness perception measured by Brief Illness Perception Questionnaire (B-IPQ)

    Time frame: Baseline, 6 month and 1 year

    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.

  9. Quality-adjusted life years,(QALYs) gathered with EuroQol-5D (EQ-5D) questionnaire.

    Time frame: Baseline to 1 year

    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.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2020
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.