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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: PRO follow up

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Jun Zhang, MD; Phone Number: +8615000420881; Email: zhangjun_njmu2011@163.com
• Study Contact Backup: Name: Dongdong Zhao, MD; Phone Number: +8618917684008; Email: zhaodd@tongji.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Jun Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Paroxysmal, symptomatic atrial fibrillation patients undergoing cryoablation；

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
routine follow-up; The patients were instructed to come to the hospital for routine follow-up at 1, 3, 6, and 12 months after the operation. If necessary, the investigators contacted the patients by phone for symptom follow-up and instructed them to come to the hospital for relevant examinations (eg: EKG, Holter, echocardiography, etc.)
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Scale Score	Anxiety Scale Score	1 year
Depression Scale Score	Depression Scale Score	1 year
Quality of Life Scale Score	Quality of Life Scale Score	1 year

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): February 28, 2023
• Study Completion (ANTICIPATED): February 29, 2024

Study Registration Dates

• First Submitted: August 20, 2022
• First Submitted That Met QC Criteria: August 20, 2022
• First Posted (ACTUAL): August 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 20, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Atrial fibrillation; follow up；patient-reported outcomes；
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Chronic Disease
• Other Study ID Numbers: NSH-PRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No