Quality of Life Influencing Factors

NCT05974098 | Completed

• 1 other identifier: atrial fibrillation2023
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• The 12-item Short Form Health Survey (SF-12)

  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

  Quality of life was measured at the start of the study，Up to 24 weeks

Interventions

Observational study OTHER

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients are from the Department of Cardiology and Department of Psychiatry, a comprehensive tertiary hospital in China. All patients who are interviewed provided written informed consents.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Shan Qu

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (1)

• Minjie Z, Zhijuan X, Xinxin S, Shan Q. Mediating effect of coping strategy and psychological status between illness perception and quality of life among patients with atrial fibrillation: a cross-sectional study. BMC Cardiovasc Disord. 2024 Sep 19;24(1):504. doi: 10.1186/s12872-024-04176-4.

  PMID: 39300328 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Observation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Medical Psychology

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 3, 2023
• Study Start: March 10, 2020
• Primary Completion: December 20, 2022
• Study Completion: May 1, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)