A Nurse-led Structured Risk Factor Management Programme to Improve Quality of Life for Patients With Atrial Fibrillation
NCT07929259, Not applicable, Not yet recruiting, The University of Hong Kong
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Nurse-led Structured Risk Factor Management Programme to Improve Quality of Life for Patients With Atrial Fibrillation | ClinicalTrials.gov |
| NCT number | NCT07929259 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 160 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | The University of Hong Kong | ClinicalTrials.gov |
| Conditions | Atrial Fibrillation (AF), Health Behaviour Change, Quality of Life | ClinicalTrials.gov |
| Interventions | A nurse-led, structured risk factor management programme for AF patients | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Health-related quality of life assessed by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) | 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. | ClinicalTrials.gov |
| Secondary | AF symptom severity assessed by Atrial Fibrillation Severity Scale (AFSS) | 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. | ClinicalTrials.gov |
| Secondary | Functional exercise capacity assessed by 6-minute Walk Test | 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. | ClinicalTrials.gov |
| Secondary | Self-efficacy assessed by General Self-Efficacy Scale (GSE) | 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. | ClinicalTrials.gov |
| Secondary | Health behaviour: Dietary pattern assessed by Mediterranean Diet Scale (MDS) Questionnaire | 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. | ClinicalTrials.gov |
| Secondary | Health behaviour: Physical activity level assessed by International Physical Activity Questionnaire-short form (IPAQ-SF) | 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. | ClinicalTrials.gov |
| Secondary | Health behaviour: Smoking status | At baseline, 12 weeks and 20 weeks | Smoking status will be assessed by self-reporting cigarette use | ClinicalTrials.gov |
| Secondary | Health behaviour: Sleep duration | At baseline, 12 weeks and 20 weeks | Sleep duration will be assessed by self-reporting average hours of sleep per night | ClinicalTrials.gov |
| Secondary | Health behaviour: Alcohol consumption level assessed by Alcohol Use Disorders Identification Test- Concise (AUDIT-C) | 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. | ClinicalTrials.gov |
| Secondary | Health behaviour: Medication adherence assessed by Medication Adherence Report Scale (MARS-5) | 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. | ClinicalTrials.gov |
| Secondary | Physiological risk parameter: Body mass index | 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. | ClinicalTrials.gov |
| Secondary | Physiological risk parameter: Systolic and diastolic blood pressure | 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. | ClinicalTrials.gov |
| Secondary | Physiological risk parameter: Fasting blood glucose | 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. | ClinicalTrials.gov |
| Secondary | Physiological risk parameter: Fasting lipid profile | 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. | ClinicalTrials.gov |
| Secondary | Life's Essential 8 (LE8) Composite Score | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)