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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05511662
Other study ID # NSH-PRO
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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