Quality of Life Influencing Factors

Completed

• Conditions: Paroxysmal Atrial Fibrillation

• Registration Number: NCT05974098
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Background: quality of life is impaired in patients with paroxysmal atrial fibrillation. The purpose of this study is to explore the mediating effects of self-efficacy, coping, depression, and anxiety on the quality of life of patients with paroxysmal atrial fibrillation. Methods: It is a cross-sectional study trial. This study aims to enroll 100 patients with paroxysmal atrial fibrillation. Illness perceptions (Brief Illness Perceptions Questionnaire; BIPQ), coping styles (Carver Brief-COPE scale; B-COPE), depression Patient Health Questionnaire-9 ,PHQ-9),anxiety (The Generalized Anxiety Disorder Questionnaire, GAD 7) and quality of life (12-item Short Form Health Survey,SF12) will be analysed. This study intends to use correlation analysis and mediation analyses to assess the mediating effects of self-efficacy, coping, depression and anxiety on the quality of life of patients with paroxysmal atrial fibrillation.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-10
• Primary Completion: 2022-12-20
• Study Completion: 2023-05-01
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-26
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

1. age 18-75 years;
2. AF diagnosis, based on a 12-lead ECG and cardiologist-led examination following the 2016 ESC Guidelines for the Management of Atrial Fibrillation
3. paroxysmal AF diagnosis given by a cardiologist according to the conversion back to the normal sinus rhythm occurs spontaneously within a week
4. ability to read and write in Chinese.

Exclusion Criteria

1. severe complications such as unstable coronary artery disease, heart failure with severe systolic dysfunction(ejection fraction≤35%)
2. AF soon after thoracic surgery;
3. malignant disease with a 1-year survival rate or a terminal illness diagnosis;
4. a diagnosed psychiatric condition that interfered with participation (including severe depression, bipolar disorder, psychotic illness of any type, dementia, acute suicidality, severe personality disorder)
5. participation in another study
6. cognitive impairment interfering with their ability to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The 12-item Short Form Health Survey (SF-12)	Quality of life was measured at the start of the study，Up to 24 weeks	The 12-item Short Form Health Survey (SF-12) is a 12-item, multipurpose short-form survey that is used to measure generic HRQoL (derived from the SF-36). The findings are weighted and summed to produce clearly interpretable scales for a participant's physical and mental well-being26. SF-12 is divided into two domains: the physical component summary (PCS) and the mental component summary (MCS). Each domain scores from 0 to 100, with higher scores indicating a better health status. The SF-12's PCS and MCS scores are based on the norms of a broad population in the United States of America, with a mean of 50

Trial Locations

Locations (1)

Shan Qu; 🇨🇳 Beijing, Beijing, China