Mobile health technology supported rehabilitation for patients with atrial fibrillation
| ISRCTN | ISRCTN13724416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13724416 |
- Submission date
- 14/06/2022
- Registration date
- 15/06/2022
- Last edited
- 08/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Atrial fibrillation (AF) is a heart condition that causes an irregular and often abnormally fast heart rate. It is an increasing global epidemic and public health challenge. Guideline-recommended integrated care based on the ABC (atrial fibrillation better care) pathway for ‘general’ patients with AF improves clinical outcomes. The ABC pathway refers to the following: Avoid stroke, Better symptom control, and Cardiovascular risk and comorbidity management, and it has been recommended in updated guidelines for the management of AF. The inappropriate prescription of oral anticoagulants (OACs) is common. Many AF patients are not anticoagulated according to their CHA2DS2-VASc risk score. Mobile Health (mHealth) and other innovative technologies are proposed for arrhythmia management. Nonetheless, mHealth-supported guideline-recommended treatment adoption in routine clinical care needs to be further clarified and adapted to the patient’s risk profile and specific patient groups (e.g., for patients receiving drug treatment only, AF ablation, or left atrial appendage occlusion [LAAO]). This study aims to investigate whether mHealth technology-supported structured follow-up rehabilitation packages adapted to patient risk profiles and different treatment patterns (e.g., for patients receiving drug treatment only, AF ablation, or LAAO) will improve guideline adherence and reduce the risk of adverse cardiovascular events.
Who can participate?
Patients aged 18 years and over with AF
What does the study involve?
Participants will use the mobile Atrial Fibrillation Application (mAFA III) for the management of AF. The follow-up report and recommendation based on the updated patient’s profile will be generated by mAFA III and proposed for the patients at 1, 2, 3, 6, 9, and 12 months to facilitate safe drug use, predict AF recurrence, and propose lifestyle modification to decrease the risk for recurrence after ablation. The patients will be followed up for adherence to the guideline-recommended treatment and cardiovascular events at 12 months.
What are the possible benefits and risks of participating?
Possible benefits to participation may include improved disease knowledge, timely communication with doctors, and the improvement of treatment adherence. This study does not involve any known physical risks or harm.
Where is the study run from?
Sixth Medical Center, Chinese PLA General Hospital (China)
When is the study starting and how long is it expected to run for?
July 2020 to May 2024
Who is funding the study?
National Natural Science Foundation of China
Who is the main contact?
Dr Guo Yutao, guoyutao@301hospital.com.cn
Contact information
Principal Investigator
28 Fuxing Road
Haidian District
Beijing
100853
China
 ORCID ID |
0000-0002-7626-7751 |
|---|---|
| Phone | +86 (0)61055499311 |
| guoyutao@301hospital.com.cn |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | Structured rehabilitation for patients with atrial fibrillation based on an integrated care approach: a prospective, observational cohort study |
| Study acronym | SRAF Registry |
| Study hypothesis | It is hypothesized that mobile health technology-supported structured follow-up rehabilitation packages adapted to patient risk profiles and different treatment patterns (e.g., for patients receiving drug treatment only, atrial fibrillation [AF] ablation, or left atrial appendage occlusion [LAAO]) will improve guideline adherence and reduce the risk of adverse cardiovascular events. |
| Ethics approval(s) | Approved 16/03/2021, Beijing Central Medical Ethics Committee of Chinese PLA General Hospital (6 Fucheng Road, 100048, Beijing, China; +86(0)10 66937166; Zhangyi@hz.com), ref: HZKY-PJ-2021-13 |
| Condition | Atrial fibrillation |
| Intervention | In this prospective, observational cohort study, patients with atrial fibrillation aged ≥18 years will be enrolled using the mobile Atrial Fibrillation Application III for self-management. Assuming an annual rate of composite outcome of “ischaemic stroke or systemic embolism, all-cause death and cardiovascular hospitalization” of 29.3% for non-ABC pathway compliance compared with 20.8% for ABC pathway compliance, at least 1475 patients would be needed to detect the outcome of the A, B and C components of the ABC pathway, assuming a withdrawal rate of 20% in the first year. The primary endpoint is adherence to guidelines regarding the A, B and C components of the ABC pathway. Ancillary analyses will be performed to determine the impact of the ABC pathway using smart technologies on the outcomes among the ‘high-risk’ population (e.g., ≥75 years old, with multimorbidities, with polypharmacy) and the application of artificial intelligence machine-learning AF risk prediction management in assessing AF recurrence. Patients with an AF burden who are taking anticoagulants will be monitored by photoplethysmography (PPG) and ECG technologies. Whether patients had compatible smart devices or experienced cardiovascular events, as well as the influence of mAFA III system support in reducing the heterogeneity of guideline adherence among primary care and Class I, Class II and III hospitals, is also assessed. |
| Intervention type | Other |
| Primary outcome measure | Adherence to guidelines based on the ABC pathway and its individual components, measured with questionnaire or telephone or clinic visit at 1 year |
| Secondary outcome measures | Measured with questionnaire or telephone or clinic visit at 1 year: 1. The composite of stroke/thromboembolism, all‐cause death and rehospitalization: 1.1. The thromboembolism endpoint includes ischaemic stroke, transient ischaemic attack (TIA), pulmonary embolism, deep vein thromboembolism (DVT), and other thromboembolisms (e.g., peripheral embolism, atrial thrombus and left atrial appendage thrombus) 1.2. All‐cause death will include cardiac death, vascular death and non‐cardiovascular death 1.3. Cardiac death includes death caused by ST‐segment elevation myocardial infarction/non‐ST‐segment elevation myocardial infarction (STEMI/NSTEMI), heart failure (HF), arrhythmia, cardiac perforation/tamponade and other deaths of cardiac origin 1.4. Vascular death will include death ascribed to ischaemic stroke, haemorrhagic stroke, systemic haemorrhage, peripheral embolism and pulmonary embolism 1.5. Rehospitalization for cardiovascular events will include stroke, systemic thromboembolism, angina, STEMI/NSTEMI, HF, and arrhythmia 2. AF recurrence after 3 months following AF ablation 3. Compliance with guideline-recommended antithrombotic management for patients undergoing LAAO or ablation plus LAAO 4. Event rates: event rate for the composite of ischaemic stroke/TIA and systemic thromboembolism, HF, cardiovascular death or rehospitalization for any cardiac cause 5. Quality of life |
| Overall study start date | 01/07/2020 |
| Overall study end date | 01/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1039 |
| Participant inclusion criteria | 1. Patients aged ≥18 years old 2. Patients had >30-s AF on a 12-lead resting electrocardiogram or Holter 3. Patient informed consent form is signed |
| Participant exclusion criteria | 1. No ECG of AF is recorded 2. No informed consent is provided |
| Recruitment start date | 01/05/2021 |
| Recruitment end date | 31/05/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Haidian District
Beijing
100048
China
Sponsor information
Hospital/treatment centre
28 Fuxing Road
Haidian District
Beijing
100853
China
| Phone | +86 (0)10-66939206 |
|---|---|
| jfjzyyhbhk@163.com | |
| Website | https://www.301hospital.com.cn/index.html |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 01/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the ethics. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 31/07/2023 | 08/08/2023 | Yes | No |
Editorial Notes
08/08/2023: Publication reference added.
15/06/2022: Trial's existence confirmed by the Beijing Central Medical Ethics Committee of Chinese PLA General Hospital.
