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

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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. 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. 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. 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. 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. 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.

Key facts

Study ID

NCT07741682

Run by

Binzhou People's Hospital

People needed

88

Starts

2024-10-05

Expected to finish

2024-11-30

Last updated by the study team

2026-08-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China

Full record on ClinicalTrials.gov

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