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CompletedNCT07741682Updated Aug 3, 2026

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

An interventional study of Intervention of the CSM-Based Self-Management Protocol for Patients After Radio frequency Ablation for Atrial Fibrillation Intervention Group and Intervention of the CSM-Based Self-Management Protocol for Patients After Radio frequency Ablation for Atrial Fibrillation Control Group in Atrial Fibrillation, sponsored by Binzhou People's Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Binzhou People's Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Oct 2024, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Sex
All
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Study 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. 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.
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Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 88 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

This is the only study on the registry with Binzhou People's Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    Description: Standard nursing plus targeted nursing intervention

    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

  • Experimental
    Control Description: Routine nursing care

    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

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

    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.

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

    A routine cardiology nursing intervention plan was adopted

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What researchers measure

Primary outcomes

  1. self-management skills

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

    Time frame: From the patient's surgery completion until 12 months postoperatively

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Study locations

1 site
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong 266000, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07741682
Lead sponsor
Binzhou People's Hospital
Collaborators
Qingdao University
Responsible party
Guangdi Xi (Clinic Nursing, Binzhou People's Hospital) — Principal investigator
First posted
Aug 3, 2026
Start date
Oct 5, 2024
Primary completion
Nov 30, 2024
Completion
Nov 30, 2024
Last update
Aug 3, 2026

Study contacts

Fuguo Yang
study chair · Qingdao University School of Nursing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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