A Nurse-led Structured Risk Factor Management Programme to Improve Quality of Life for Patients With Atrial Fibrillation

Atrial fibrillation (AF) is the most common sustained heart rhythm disorder. It increase the risk of stroke, heart failure, and death. Its symptoms, including palpitation, fatigue, and breathlessness, often limit daily activities and reduce quality of life, even in patients receiving treatment to control heart rhythm or rate. Comorbidity and risk factor contribute to the onset and progression of AF. International guidelines now recommend managing comorbidity and risk factors as a core pillar of AF care. However, translation into routine practice remains sub-optimal, characterized by brief, unstructured lifestyle counselling. This study is an assessor-blinded, parallel-group randomised controlled trial aiming to evaluate the effects of a nurse-led, structured risk factor management program on health-related quality of life, symptom burden, and cardiovascular health in AF patients, thereby informing secondary prevention of AF.

This study will be conducted in the specialist outpatient clinics of the cardiac units of three regional hospitals in Hong Kong. Eligible participants are adults aged ≥18 years who are (1) referred for management of symptomatic AF at the specialist outpatient clinic, (2) community-dwelling, (3) in possession of a smartphone, and (4) with at least one risk factor (hypertension, diabetes mellitus; BMI ≥23kg/m2; waist circumference ≥100cm for males or ≥90cm for females; dyslipidaemia; obstructive sleep apnoea; active smoking; alcohol use \>3 standard drinks per week; and physical inactivity ). The sample size was estimated for the primary outcome of HRQoL at T1. Informed by two comparable nurse-led behavioural interventions and anticipating a medium effect, 64 participants per arm are required to detect an effect size of 0.5 with 80% power at a two-sided 5% significance level (G\*Power 3.1.9.7). Applying a pooled baseline standard deviation of 18.6 points reported in a comparable Hong Kong AF population, this detects a between-group difference of 9.3 points on the primary HRQoL instrument, exceeding the 5-point minimal clinically important difference. Allowing for 20% attrition, 160 participants (80 per group) will be recruited. Participants will be randomly allocated in a 1:1 ratio to the intervention group (12-week nurse-led risk factor management programme in addition to usual care) or control group (usual care only).

Evaluation outcomes will be measured at baseline (T0), 12 weeks (T1), and 20 weeks (T2) thereafter. The primary outcome is health-related quality of life. Secondary outcomes include AF symptom severity, functional exercise capacity (distance walked in 6 minutes), self-efficacy, health behaviours (diet, physical activity, smoking status, sleep duration, alcohol consumption, and medication adherence), physiological parameters (body mass index, blood pressure, fasting lipid profile and fasting blood glucose), and overall cardiovascular health measured by the American Heart Association's Life Essential 8 score.

After double data entry, outcome analyses will be performed on an intention-to-treat basis. Normality of continuous variables will be assessed using the Shapiro-Wilk test to guide the choice between parametric and non-parametric methods. Baseline characteristics will be summarised as mean ± SD or median (IQR) for continuous variables and as frequencies and percentages for categorical variables, with baseline between-group homogeneity assessed using the independent t-test, chi-square test, or Mann-Whitney U test as appropriate. Primary analyses will employ generalised estimating equations (GEE) to examine between-group change across T0, T1, and T2, incorporating group and time as interaction terms and adjusting for a priori covariates (age, sex, AF type, AF duration, left atrial size, and left ventricular ejection fraction). Analyses will use IBM SPSS version 29.0, with a two-sided p-value \< 0.05 considered statistically significant.

The participants in the intervention group will receive a 12-week, structured, nurse-led risk factor management program for AF, in addition to the usual care at the study hospital.

Behavioral: A nurse-led, structured risk factor management programme for AF patients

The participants in the control group will receive the usual care provided by study hospital, comprising physician consultations and medication prescription at routine follow-up, without a structured risk factor management programme.

This program, grounded in the Information-Motivation-Behavioral Skills model and Social Cognitive Theory, is designed to improve AF self-management and support sustained modification of behavioral risk factors . Delivered by a registered nurse with cardiac specialty, this program comprises 4 components:

1. A 60-minute face-to-face individual session delivered in week 1 for risk profile assessment, AF self-management education, and personalized behavioral change planning
2. Self-monitoring via self-management booklet, checklist, or smartphone step tracking according to participants' preference and capability, with progress reviewed at each contact
3. 6 bi-weekly telephone follow-up calls (Weeks 2, 4, 6, 8, 10, 12) on stages of behavioral change: behavioral initiation, early problem-solving, behavioral consolidation, behavioral maintenance, relapse prevention and transition to self-management
4. Weekly text messages sustaining participant's engagement with agreed behavioral goals.

Time frame: At baseline, 12 weeks and 20 weeks

The 20-item AFEQT will be used to measure disease-specific health-related quality of life across four subscales: symptoms, daily activities, treatment concerns and treatment satisfaction. Each item is rated on a 7-point Likert scale. Raw scores are transformed to a 0-100 scale, with higher scores indicating better health status.

Time frame: At baseline, 12 weeks and 20 weeks

The 19-item AFSS will be used to assess patient-perceived AF symptom burden and severity. The instrument comprises two items on demographic characteristics, five items on AF disease burden (the frequency, overall severity and duration of symptomatic AF episodes), one item on global well-being, four items on AF-related healthcare utilization, and seven items on AF symptom severity. The seven AF symptom severity items are rated on a five-point Likert scale, yielding a total AFSS severity score ranging from 0 to 35, with higher scores indicating more severe symptoms.

Time frame: At baseline, 12 weeks and 20 weeks

The total distance walked in 6-minute walk test will be used to measure functional exercise capacity. Participants will be instructed to walk at their own pace along an uninterrupted 30-m corridor for 6 minutes with continuous heart rate monitoring. A longer distance indicates better functional exercise capacity.

Time frame: At baseline, 12 weeks and 20 weeks

A 10-item GSE will be used to measure individual's perceived capability to cope with stressful or challenging situations. This scale was commonly used to predict individual's behaviour, goal intentions and self-regulatory commitments, which are central in health promotion. Each item on a 4-point Likert scale and summed, with higher score indicating greater self-efficacy.

Time frame: At baseline, 12 weeks and 20 weeks

A 13-item MDS Questionnaire will be used to assess self-reported adherence to Mediterranean dietary pattern. Each item is rated dichotomously (yes/ no) and summed, with higher score indicating greater adherence.

Time frame: At baseline, 12 weeks and 20 weeks

The 7-item IPAQ-SF will be used to measure self-reported physical activity over the past week across four domains: vigorous activities, moderate activities, walking and sitting.68 Scores are expressed in metabolic equivalent of task (MET)-minutes per week, where higher values indicate higher energy expenditure.

Time frame: At baseline, 12 weeks and 20 weeks

Smoking status will be assessed by self-reporting cigarette use

Time frame: At baseline, 12 weeks and 20 weeks

Sleep duration will be assessed by self-reporting average hours of sleep per night

Time frame: At baseline, 12 weeks and 20 weeks

The 3-item AUDIT-C, a concise version of AUDIT, will be used to assess self-reported alcohol use across frequency of use, quantity of use, and frequency of health drinking. Each item is scored from 0 to 4 points, yielding a total score 0-12 with higher scores indicating greater alcohol use.

Time frame: At baseline, 12 weeks and 20 weeks

The 5-item MARS-5 will be used to assess self-reported unintentional and intentional medication adherence. Each item is rated on a 5-point Likert scale and summed, with higher score indicating better adherence.

Time frame: At baseline, 12 weeks and 20 weeks

Body mass index will be calculated as dividing body weight (kilogram) by body height (meter) squared . Body weight and height are measured by a calibrated scale and stadiometer respectively.

Time frame: At baseline, 12 weeks and 20 weeks

Systolic and diastolic blood pressure will be measured using a digital automatic blood pressure monitor with an appropriate size cuff. Participants will be asked to relax and sit quietly for 3-5 minutes before the blood pressure measurement. They will be seated with their arm supported at heart level for the measurement.

Time frame: At baseline, 12 weeks and 20 weeks

A fasting blood glucose will be assessed by a validated point-of-care device (BioHermes GluCoA1c) using a capillary blood sample obtained from a finger stick after 8 hours of fasting.

Time frame: At baseline, 12 weeks and 20 weeks

A portable point-of-care analyser (VivaDiag Lipid Testing System) will be used to measure circulating cholesterol (total cholesterol, low-density lipoprotein \[LDL\], high-density lipoprotein \[HDL\], triglycerides \[TG\]). Approximately 10uL of capillary blood sample will be collected at each measurement.

Time frame: At baseline, 12 weeks and 20 weeks

LE8 is a cardiovascular health score. It comprises 8 components: diet (MDS score) , physical activity (minute of moderate-intensity activity per week), nicotine exposure (self-reported use of cigarettes), sleep health (average hours of sleep per night), body mass index (kilogram/ meter\^2), blood lipids (non-HDL cholesterol), blood glucose (fasting blood glucose or HbA1c for diabetes) and blood pressure (systolic and diastolic blood pressure). Each LE8 components are scored on a scale of 0 to 100 points, allowing generation of a composite cardiovascular health score which is the unweighted average of all components. Total scores range from 0 to 100 points. Higher scores correspond to better cardiovascular health.

Effects of a Nurse-led Structured Risk Factor Management Programme on Health-related Quality of Life, Symptom Burden and Cardiovascular Health in Patients With Atrial Fibrillation: A Randomised Controlled Trial