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
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.
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Norrlands Universitetssjukhus | Umeå | Region Västerbotten |
Lead Sponsor | Collaborator |
---|---|
Umeå University |
Sweden,
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 |
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