Clinical trial NCT04609202: Person Centered Nurse Led Atrial Fibrillation Care
Official title: Measuring the Effect of Person Centered, Nurse Led Care on Health-related Quality of Life in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
person centred care
health related quality of life
nurse led
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health related quality of life measured by EuroQol-5D (EQ-5D) questionnaire
timeFrame: Baseline, 6 month and 1 year
measure: Arrhythmia related quality of life measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)
timeFrame: Baseline, 6 month and 1 year
Secondary outcomes:
measure: Anxiety measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 6 month and 1 year
measure: Depression measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 6 month and 1 year
measure: Symptom burden measured by Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmias (ASTA)
timeFrame: Baseline, 6 month and 1 year
measure: Lifestyle habits-smoking, measured by questionnaire,
timeFrame: Baseline, 6 month and 1 year
measure: Lifestyle habits-diet by questionnaire
timeFrame: Baseline, 6 month and 1 year
measure: Lifestyle habits-physical activity by questionnaire
timeFrame: Baseline, 6 month and 1 year
measure: Lifestyle habits-alcohol use by questionnaire
timeFrame: Baseline, 6 month and 1 year
measure: Illness perception measured by Brief Illness Perception Questionnaire (B-IPQ)
timeFrame: Baseline, 6 month and 1 year
measure: Quality-adjusted life years,(QALYs) gathered with EuroQol-5D (EQ-5D) questionnaire.
timeFrame: Baseline to 1 year
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus
state: Region Västerbotten
Study officials:
affiliation: Umeå University
name: Karin H Ängerud
role: PRINCIPAL_INVESTIGATOR
References: