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

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05511662
Collaborator
(none)
240
1
17.9
13.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
240 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Feb 29, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. follow-up rate [1-year]

    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

Secondary Outcome Measures

  1. Anxiety Scale Score [1 year]

    Anxiety Scale Score

  2. Depression Scale Score [1 year]

    Depression Scale Score

  3. Quality of Life Scale Score [1 year]

    Quality of Life Scale Score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 18-85 years old;Symptomatic, paroxysmal atrial fibrillation with cryoablation;Ability to understand and sign informed consent;
Exclusion Criteria:
  • none

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jun Zhang Shanghai Shanghai China 200072

Sponsors and Collaborators

  • Shanghai 10th People's Hospital

Investigators

  • Study Chair: Yawei Xu, PhD, Tongji University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ya-Wei Xu, Director of Cardiology, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT05511662
Other Study ID Numbers:
  • NSH-PRO
First Posted:
Aug 23, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ya-Wei Xu, Director of Cardiology, Shanghai 10th People's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022