The Effect of an Intervention Based on The CSM on Self-Management in Patients After Atrial Fibrillation Ablation

NCT07741682 | Completed

• 1 other identifier: BinZhou People's Hospital
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Aim The investigators will validate the feasibility and effectiveness of a self-management intervention program based on the Common-Sense Model of Self-Regulation for patients after atrial fibrillation ablation. This study aims to analyze the effects of the intervention program on patients' self-management ability, postoperative recurrence rates, recurrence risk perception, medical coping strategies, and perceived social support after atrial fibrillation ablation. Methods This study adopts a randomized controlled trial design. Inpatients admitted to two cardiovascular wards of a tertiary hospital in Shandong Province will be recruited between October 5 and November 30, 2024. Participants will be allocated via stratified cluster randomization: patients from Campus A will be assigned to the intervention group, and patients from Campus B will be assigned to the control group. Participants in the control group will receive routine cardiovascular nursing care. On the basis of routine care, the intervention group will additionally receive a self-management intervention guided by the Common-Sense Model of Self-Regulation. The intervention implementation period will last 6 months, with scheduled follow-up continuing until 12 months after surgery. Outcome indicators will be evaluated at five time points: baseline, 1 month, 3 months, 6 months, and 12 months postoperatively. All intervention procedures are planned to be completed by December 2025. All collected data will be analyzed using IBM SPSS Statistics 29.0, with the significance level set at α=0.05. Planned Outcome Analyses

1. 1.Self-management ability Generalized Estimating Equations (GEE) will be used to examine group effects and time effects for self-management ability scores. Intergroup comparisons of self-management ability scores will be conducted at 1, 3, 6, and 12 months postoperatively. Within the intervention group, pairwise comparisons across different follow-up time points for self-management ability scores will also be performed.
2. 2.Postoperative atrial fibrillation recurrence GEE will be applied to assess intergroup differences and longitudinal changes in postoperative recurrence rates. Intergroup comparisons of recurrence rates will be carried out at 3, 6, and 12 months after ablation. Long-term changes in recurrence rates from 3 months to 12 months postoperatively will be explored within the intervention group.
3. 3.Perception of recurrence risk Group effects and time effects for recurrence risk perception scores will be tested. Intergroup comparisons of recurrence risk perception will be performed at all scheduled follow-up time points, and longitudinal changes in recurrence risk perception within the intervention group will be analyzed.
4. 4.Medical coping strategies Three dimensions of medical coping strategies (confrontation, avoidance, and submission) will be analyzed. Intergroup comparisons will be conducted for all follow-up time points. Longitudinal changes in confrontation, avoidance and submissive coping tendencies will be assessed in the intervention group across the whole follow-up window.
5. 5.Perceived social support Group and time effects for social support scores will be evaluated. Intergroup comparisons of social support levels will be completed at each postoperative time point, and longitudinal trends in social support within the intervention group will be explored.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• self-management skills

  This indicator is measured using the Atrial Fibrillation Self-Management Ability Scale.

  From the patient's surgery completion until 12 months postoperatively

Study Arms (2)

Description: Standard nursing plus targeted nursing intervention

EXPERIMENTAL

Arm 1: Intervention Description: Standard nursing plus targeted nursing intervention

Behavioral: Intervention of the CSM-Based Self-Management Protocol for Patients After Radio frequency Ablation for Atrial Fibrillation Intervention Group

Control Description: Routine nursing care

EXPERIMENTAL

Arm 2: Control Description: Routine nursing care

Behavioral: Intervention of the CSM-Based Self-Management Protocol for Patients After Radio frequency Ablation for Atrial Fibrillation Control Group

Interventions

Intervention of the CSM-Based Self-Management Protocol for Patients After Radio frequency Ablation for Atrial Fibrillation Intervention Group BEHAVIORAL

Implementation of a CSM-based nursing intervention program in addition to routine care. This study used the "Final Draft of the CSM-Based Self-Management Protocol for Postoperative Care Following Radio frequency Ablation for Atrial Fibrillation," previously developed by the research team, to implement the intervention for the intervention group. The intervention period spanned from 1 day before surgery to 3 months after surgery.

Description: Standard nursing plus targeted nursing intervention

Intervention of the CSM-Based Self-Management Protocol for Patients After Radio frequency Ablation for Atrial Fibrillation Control Group BEHAVIORAL

A routine cardiology nursing intervention plan was adopted

Control Description: Routine nursing care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with atrial fibrillation based on electrophysiological testing；
• Planned radio frequency ablation procedure；
• Patients whose condition is stable, who have impaired consciousness, and who are able to communicate without difficulty；
• Patients who know how to use a smartphone and WeChat, or whose family members are willing to help them use these apps；
• Voluntarily participate in this study and sign the informed consent form.

You may not qualify if:

• Combined severe heart, brain, lung, kidney, and other serious diseases；
• Current or past history of mental illness, psychiatric disorders, or cognitive impairments；
• Has participated in other studies.

Sponsors & Collaborators

• Binzhou People's Hospital: lead
• Qingdao University: collaborator

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Fuguo Yang

  Qingdao University School of Nursing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic Nursing

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: August 3, 2026
• Study Start: October 5, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

CN (1)