Person Centered Nurse Led Atrial Fibrillation Care

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04609202
• Other study ID #: Flimmerstudie2020
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: May 20, 2024

Study information

• Verified date: November 2023
• Source: Umeå University
• Contact: Karin H Ängerud, PhD
• Phone: +46907869263
• Email: karin.hellstrom.angerud[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• Nurse led person centred care
Person centred care include patiens narratives, partnership and documentation of a health plan.

Other:
• Usual care
Usual care provided by doctors

Locations

Country	Name	City	State
Sweden	Norrlands Universitetssjukhus	Umeå	Region Västerbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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