Promoting Atrial Fibrillation Screening in Primary Care
ConditionAtrial Fibrillation New Onset
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
aged 65 years or above
living in community
Disqualifiers
with a previous confirmed diagnosis of atrial fibrillation
with implanted ICD or pacemaker
unable to provide consent
involving in other atrial fibrillation screening program
Trial design
Design model
Sequential
Treatments tested in this trial
SEARCH-AF
BehavioralSEARCH-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.
Treatment groups
4,800 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
End of the intervention (T0), three-month (T1) and six-month (T2) after the intervention.Secondary outcomes
1
Anticoagulation rate
Anticoagulation rate among the newly detected atrial fibrillation cases. The data will be collected via medical records (primary care medical system) review and patient interview.
Time frame
Three-month and six-month post the intervention2
Cost-effectiveness
Cost-effectiveness refers to the cost of screening for one atrial fibrillation and preventing for one stroke, respectively. It will be assessed using cost-effectiveness ratio. The cost of intervention will include the direct screening cost (screening tool, manpower for carrying out the screening, training on screening, leaflet etc), cost on anticoagulation (expense on oral anticoagulants) and stroke treatment (in-hospital and out-of-hospital cost on stroke treatment). The cost of control group will include the cost on anticoagulation(expense on oral anticoagulants) and stroke treatment (in-hospital and out-of-hospital cost on stroke treatment ). All the cost data will be collected using a patient-reported information sheet.
Time frame
Six-month post the intervention3
Atrial fibrillation associated events
Including stroke, bleeding events associated with anticoagulation (referred to bleeding that requires in-hospital treatment), and death. The data will be collected via medical records (primary care medical system) and patient interview.
Time frame
Three-month and six-month post the intervention4
Atrial fibrillation related medical resource consumption
Including the number of in-hospital and out-of-hospital visits due to atrial fibrillation. Such data will be collected using a patient-reported information sheet.
Time frame
Three-month and six-month post the interventionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: