Patient-reported Outcome Follow-up Based on the Northern Shanghai Community Chronic Disease Management System

Atrial Fibrillation Clinical Trial

Official title:

Influence of Patient-reported Outcome Follow-up Based on the Northern Shanghai Community Chronic Disease Management System on the Follow-up Compliance and Satisfaction of Patients With Atrial Fibrillation After Cryoablation.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05511662
• Other study ID #: NSH-PRO
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: August 2022
• Source: Shanghai 10th People's Hospital
• Contact: Jun Zhang, MD
• Phone: +8615000420881
• Email: zhangjun_njmu2011[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Influence of patient-reported outcome follow-up based on the northern Shanghai community chronic disease management system on the follow-up compliance and satisfaction of patients with atrial fibrillation after cryoablation.

Description:

Influence of patient-reported outcome follow-up based on the northern Shanghai community chronic disease management system on the follow-up compliance and satisfaction of patients with atrial fibrillation after cryoablation.Among patients with left atrial fibrillation after cryoablation at several sites, 240 consecutive eligible patients were randomly assigned to routine follow-up (control) and PRO (test) for 12 months. Follow-up, comparison of postoperative follow-up compliance, satisfaction, etc.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: February 29, 2024
• Est. primary completion date: February 28, 2023
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 18-85 years old;Symptomatic, paroxysmal atrial fibrillation with cryoablation;Ability to understand and sign informed consent;

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Atrial Fibrillation
• Chronic Disease

Intervention

Other:
• PRO follow up
On the basis of the routine follow-up group, interactive follow-up was conducted through the chronic disease follow-up system, including the APP for regular follow-up (bound to sign the informed consent form, and the account of the patient and his immediate family who can be familiar with the WeChat applet), SMS reminders, and doctors when necessary. Wechat/platform communication and exchange, inappropriate ECG data upload and other multi-dimensional follow-up, at the same time assisting the ECG integrated follow-up platform for ECG data management and medication guidance

Locations

Country	Name	City	State
China	Jun Zhang	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	follow-up rate	From the beginning of the study to the end of the study (a total of 12 months), the number of patients who completed each follow-up visit was standardized as a percentage of the total number of patients	1-year
Secondary	Anxiety Scale Score	Anxiety Scale Score	1 year
Secondary	Depression Scale Score	Depression Scale Score	1 year
Secondary	Quality of Life Scale Score	Quality of Life Scale Score	1 year