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

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

The goal of this clinical trial is to evaluate the effects of a nurse-led, structured risk factor management programme on health-related quality of life, symptom burden and cardiovascular health in adults with atrial fibrillation (AF).

AF is the most common 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. in the proposed nurse-led program, the cardiac nurse will teach AF patients how to manage health habits that affect AF, including eating well, staying active, sleeping well, not smoking, drinking less alcohol, and taking medicines as prescribed. A nurse works with each person to set small, realistic goals.

The main questions it aims to answer are:

1. Does the programme improve health-related quality of life for AF patients?
2. Does the programme improve symptom burden for AF patients?
3. Does the programme improve the functional exercise capacity for AF patients?
4. Does the programme increase the reported self-efficacy level for participants?
5. Does the programme improve the health behaviours, physiological risk parameters and cardiovascular health score for participants?

Researcher will compare interventional group (80 AF participants joining the 12-week program in addition to usual care) to a control group (80 AF participants receive usual care only) to see if the program works to improve the quality of life, symptom burden and overall cardiovascular health than usual care alone among AF patients.

Participants in the intervention group will:

1. Receive a 1-hour face-to-face individual session with nurse for structured AF self-management education and personalized behavioural change planning in week 1
2. Keep track of their own health behaviours using a self-management booklet
3. Get 6 bi-weekly telephone follow-up calls from the nurse to review progress and support staged behavioural change
4. Receive weekly tailored text messages with reminders and encouragement

The study will take place at three hospitals in Hong Kong and will enrol about 160 adults. Each person will take part for about 5 months. Researchers will evaluate outcome (quality of life, AF symptom severity, functional exercise capacity, self-efficacy, health behaviours, body mass index, blood pressure, blood cholesterol, blood sugar, Life Essential 8 score) at three timepoint: baseline, upon completion of the programme (12 week), and 8 weeks thereafter (20 week).

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Atrial Fibrillation (AF); Health Behaviour Change
• Intervention / Treatment: Behavioral: A nurse-led, structured risk factor management programme for AF patients

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimmy Wai Ping Chan; Phone Number: +852 55369048; Email: kimmycwp10@connect.hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Princess Margaret Hospital, Prince of Wales Hospital and Tuen Mun Hospital
    • Contact: Kimmy Wai Ping Chan; Phone Number: +852 55369048; Email: kimmycwp10@connect.hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Chinese adults aged ≥18 years who are referring for management of symptomatic paroxysmal or persistent AF at the specialist outpatient clinics
2. Community-dwelling
3. Possessed a smartphone
4. Has the presence of at least one of the following risk factors: 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 (i.e. <150 minutes of moderate-to-vigorous physical activity per week, or an average of <8000 steps per day)

Exclusion Criteria:

1. Cannot understanding Cantonese or reading Chinese,
2. Has impaired communication
3. Has psychiatric problems
4. Has cognitive impairment (i.e. Abbreviated Mental Test ≤6)
5. Has severe co-existing medical conditions (e.g. terminal illness).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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: 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; Self-monitoring via self-management booklet, checklist, or smartphone step tracking according to participants' preference and capability, with progress reviewed at each contact; 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; Weekly text messages sustaining participant's engagement with agreed behavioral goals.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life assessed by Atrial Fibrillation Effect on Quality-of-Life (AFEQT)	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.	At baseline, 12 weeks and 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF symptom severity assessed by Atrial Fibrillation Severity Scale (AFSS)	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.	At baseline, 12 weeks and 20 weeks
Functional exercise capacity assessed by 6-minute Walk Test	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.	At baseline, 12 weeks and 20 weeks
Self-efficacy assessed by General Self-Efficacy Scale (GSE)	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.	At baseline, 12 weeks and 20 weeks
Health behaviour: Dietary pattern assessed by Mediterranean Diet Scale (MDS) Questionnaire	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.	At baseline, 12 weeks and 20 weeks
Health behaviour: Physical activity level assessed by International Physical Activity Questionnaire-short form (IPAQ-SF)	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.	At baseline, 12 weeks and 20 weeks
Health behaviour: Smoking status	Smoking status will be assessed by self-reporting cigarette use	At baseline, 12 weeks and 20 weeks
Health behaviour: Sleep duration	Sleep duration will be assessed by self-reporting average hours of sleep per night	At baseline, 12 weeks and 20 weeks
Health behaviour: Alcohol consumption level assessed by Alcohol Use Disorders Identification Test- Concise (AUDIT-C)	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.	At baseline, 12 weeks and 20 weeks
Health behaviour: Medication adherence assessed by Medication Adherence Report Scale (MARS-5)	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.	At baseline, 12 weeks and 20 weeks
Physiological risk parameter: Body mass index	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.	At baseline, 12 weeks and 20 weeks
Physiological risk parameter: Systolic and diastolic blood pressure	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.	At baseline, 12 weeks and 20 weeks
Physiological risk parameter: Fasting blood glucose	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.	At baseline, 12 weeks and 20 weeks
Physiological risk parameter: Fasting lipid profile	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.	At baseline, 12 weeks and 20 weeks
Life's Essential 8 (LE8) Composite Score	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.	At baseline, 12 weeks and 20 weeks

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): November 16, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: November 4, 2026
• First Submitted That Met QC Criteria: November 4, 2026
• First Posted (Actual): November 10, 2026

Study Record Updates

• Last Update Posted (Actual): November 10, 2026
• Last Update Submitted That Met QC Criteria: November 4, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Quality of Life; Lifestyle Intervention; Secondary Prevention; Risk Factor Management; Health Behavior Change Program
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: CIRB-2026-557-5; 2026.572 (Other Identifier: The Joint CUHK-NTEC Clinical Research Ethics Committee); HKWC-2026-527 (Other Identifier: Institutional Review Board of HKU/ HA HKW)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No