Atrial FibrillationNCT07741682
The Effect of an Intervention Based on The CSM on Self-Management in Patients After Atrial Fibrillation Ablation
A study testing Intervention of the CSM-Based Self-Management Protocol for Patients After Radio frequency Ablation for Atrial Fibrillation Intervention Group in people with Atrial Fibrillation, run by Binzhou People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Intervention of the CSM-Based Self-Management Protocol for Patients After Radio frequency Ablation for Atrial Fibrillation Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 5 Oct 2024to 30 Nov 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
About this study
Official title: The Effect of an Intervention Based on The Common-Sense Model of Self-Regulation on Self-Management in Patients After Atrial Fibrillation Ablation: A Randomized Controlled Trial
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.
Read more
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
- 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.
- 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.
- 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.
- 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.
- 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
- Being tested
- Intervention of the CSM-Based Self-Management Protocol for Patients After Radio frequency Ablation for Atrial Fibrillation Intervention Group, Intervention of the CSM-Based Self-Management Protocol for Patients After Radio frequency Ablation for Atrial Fibrillation Control Group
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention of the CSM-Based Self-Management Protocol for Patients After Radio frequency Ablation for Atrial Fibrillation Intervention GroupBehavioural
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.
Intervention of the CSM-Based Self-Management Protocol for Patients After Radio frequency Ablation for Atrial Fibrillation Control GroupBehavioural
A routine cardiology nursing intervention plan was adopted
| Study group | Role | What they receive |
|---|---|---|
| Description: Standard nursing plus targeted nursing intervention | Experimental | Arm 1: Intervention Description: Standard nursing plus targeted nursing intervention Receives: 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 Receives: Behavioral: Intervention of the CSM-Based Self-Management Protocol for Patients After Radio frequency Ablation for Atrial Fibrillation Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-management skills
This indicator is measured using the Atrial Fibrillation Self-Management Ability Scale.
Measured: From the patient's surgery completion until 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start5 Oct 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Binzhou People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Qingdao University
- Responsible party
- Principal investigator, Guangdi Xi, Binzhou People's Hospital
- Investigators
- Fuguo Yang, Study chair, Qingdao University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741682
- Sponsor's protocol ID
- BinZhou People's Hospital
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No