NCT05511662

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 20, 2022

Last Update Submit

August 20, 2022

Conditions

Keywords

Atrial fibrillation; follow up;patient-reported outcomes;

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Anxiety Scale Score

    1 year

  • Depression Scale Score

    1 year

  • Quality of Life Scale Score

    1 year

Study Arms (2)

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

Interventions

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

PRO follow-up

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Paroxysmal, symptomatic atrial fibrillation patients undergoing cryoablation;

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jun Zhang

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yawei Xu, PhD

    Tongji University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiology

Study Record Dates

First Submitted

August 20, 2022

First Posted

August 23, 2022

Study Start

September 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 29, 2024

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations