Promoting Atrial Fibrillation Screening in Primary Care

NCT06458829 | Not Yet Recruiting

• 1 other identifier: Sunyatsenu
• Study Type: interventional
• Target: 4,800
• Locations: 0 countries
• Sites: N/A

Brief Summary

Atrial fibrillation is the most common sustained cardiac arrhythmia in adults. Due to the asymptomatic and paroxysmal nature (randomly and shortly occurring of atrial fibrillation, and can therefore remain unnoticed) of atrial fibrillation. Atrial fibrillation increases the risk of stroke five fold if left untreated. Screening in old populations above age 65 years is helpful to find more atrial fibrillation cases. However, screening for atrial fibrillation is not well implemented in China. Thus, this project aims to promote atrial fibrillation screening in primary care centers in China. We will develop an intervention program (SEARCH-AF) and examine the effects (including the clinical effects and implementation effects) of program.

Conditions

Atrial Fibrillation New Onset

Keywords

Atrial Fibrillation; Disease screening

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation detection rate

  Rate of newly detected atrial fibrillation. The data will be collected via medical records (primary care medical system) review and patient interview.

  End of the intervention (T0), three-month (T1) and six-month (T2) after the intervention.

Secondary Outcomes (5)

• Anticoagulation rate

  Three-month and six-month post the intervention

• Cost-effectiveness

  Six-month post the intervention

• Atrial fibrillation associated events

  Three-month and six-month post the intervention

• Atrial fibrillation related medical resource consumption

  Three-month and six-month post the intervention

• Compliance with atrial fibrillation screening

  Three-month and six-month post the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive SEARCH-AF intervention which includes opportunistic screening and screening promoting strategies.

Behavioral: SEARCH-AF

Control group

ACTIVE COMPARATOR

All the control groups will finally receive the SEARCH-AF intervention.

Behavioral: SEARCH-AF

Interventions

SEARCH-AF BEHAVIORAL

SEARCH-AF program will include opportunistic screening among old adults during primary care visits and promoting strategies. Promoting strategies will be developed based on the Consolidated Framework for Implementation Research framework which may include leadership engagement, policy support, providing screening resources, atrial fibrillation screening and management training. General practitioner or nurse in each health care center will implement point-on-care screening. The intervention will last for six months and followed up for another six months.

Control group; Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• aged 65 years or above
• living in community

You may not qualify if:

• with a previous confirmed diagnosis of atrial fibrillation
• with implanted ICD or pacemaker
• unable to provide consent
• involving in other atrial fibrillation screening program

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xi CAO

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi CAO, PhD

CONTACT

(86)02084333829; caox29@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Model Details: Stepped-Wedge Cluster Randomized Trial. Six community centers will be included. There will be three steps for intervention implementation. Tat each step, two centers will be randomly assigned to receive intervention, other centers will serve as control group or maintain post-intervention status.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 14, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share