Atrial FibrillationNCT05511662
Patient-reported Outcome Follow-up Based on the Northern Shanghai Community Chronic Disease Management System
An observational study of Atrial Fibrillation, run by Shanghai 10th People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PRO follow up
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Paroxysmal, symptomatic atrial fibrillation patients undergoing cryoablation；
Who may be able to join
- 18-85 years old;Symptomatic, paroxysmal atrial fibrillation with cryoablation；Ability to understand and sign informed consent；
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- PRO follow up
- Keywords
- Atrial fibrillation; follow up；patient-reported outcomes；
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO follow upOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PRO follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-year
Secondary outcomes (3)
Anxiety Scale Score
Anxiety Scale Score
Measured: 1 year
Depression Scale Score
Depression Scale Score
Measured: 1 year
Quality of Life Scale Score
Quality of Life Scale Score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yawei Xu, PhD, Study chair, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511662
- Sponsor's protocol ID
- NSH-PRO
- Status last verified
- Aug 2022
- First submitted
- 20 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05511662
- Acronym / sponsor ID
- NSH-PRO
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation; follow up；patient-reported outcomes；
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: PRO follow upOn 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Paroxysmal, symptomatic atrial fibrillation patients undergoing cryoablation；
Key inclusion criteria (1 listed)
- 18-85 years old;Symptomatic, paroxysmal atrial fibrillation with cryoablation；Ability to understand and sign informed consent；
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO follow upOn 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 |
Primary outcome
follow-up rate
Time frame: 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
3 secondary outcomes
Anxiety Scale Score
Time frame: 1 year
Depression Scale Score
Time frame: 1 year
Quality of Life Scale Score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yawei Xu, PhD study chair
Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhang, MD (+8615000420881, zhangjun_njmu2011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
follow-up rate (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.