NURSE-led Follow-up in Patients Undergoing CATheter Ablation for Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: usual care; Behavioral: educational program; Behavioral: risk factors management; Behavioral: telephone and e-mail contact

• Registration Number: NCT05333445
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

The study aims to examine the effect of nurse-led education program on quality of life, atrial fibrillation (AF) risk factors, AF symptomatology, arrhythmia recurrence rate, and readmission rate after AF catheter ablation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-25
• Study First Submitted QC: 2022-04-11
• Study Start: 2022-04-15
• Study First Posted: 2022-04-19
• Status Verified: 2024-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-04-30
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Derivatives from the outpatient clinic of the center itself, as well as patients referred from other centers that have ours as a reference for a first AF ablation procedure.
• Have signed the informed consent.

Exclusion Criteria

• Patients with cognitive impairment or disorientation.
• Patients with problems of comprehension or expression of Spanish or Catalan.
• Patients who are part of the medical or nursing group.
• Patient with defined heart failure with a left ventricular ejection fraction (LVEF) less than 40% and a NYHA III or IV.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nursing intervention	telephone and e-mail contact	The NI will be performed at 3 times: face to face between 21 and 7 days before admission, between 7 and 15 days after the date of ablation, and 6 months after the ablation procedure.
control group	usual care	After hospital discharge, all patients will be referred to their primary care physician or cardiologist for follow-up. Patients will receive standard follow-up checks by the medical team will not receive structured education from the nurse.
Nursing intervention	risk factors management	The NI will be performed at 3 times: face to face between 21 and 7 days before admission, between 7 and 15 days after the date of ablation, and 6 months after the ablation procedure.
Nursing intervention	educational program	The NI will be performed at 3 times: face to face between 21 and 7 days before admission, between 7 and 15 days after the date of ablation, and 6 months after the ablation procedure.

Primary Outcome Measures

Name	Time	Method
changes from the baseline and better score in the validated ASTA questionnaire of the intervention group compared to the control group at 12 months in quality of life of patients .	12 months	We will use the second part of ASTA questionnaire: it consists of 13 questions and the answers are measured using a Likert frequency scale from "Never = 0" to "Always = 4". Higher scores on this scale represent poorer quality of life.

Secondary Outcome Measures

Name	Time	Method
differences between both groups in the score obtained in the adapted AFKAT questionnaire patient's knowledge of AF.	3 months	differences between both groups in the Level of knowledge of FA through the AFKAT questionnaire validated in English but adapted and translated into Spanish by our team. It consists of 25 questions with dichotomous True/False answers. The more true answers, the better knowledge the participant has.
calls and emails received	12 months	Quantify the calls and emails received from patients to the FA nurse.
differences between both groups in the score received by the patients in the User Experience Questionnaire based on the Picker-33 Patient Experience Questionnaire	3 months	It consists of 14 closed-ended questions and is performed using a checklist to assign numerical values to subjective satisfaction using a Likert scale from "No = 0" to "Yes, always = 4". Higher scores on this scale represent greater satisfaction. An open question has been added so that participants can add their suggestions
number of participants with recurrences at AF rhythm	12 months	number of AF detected by ECG or 24-hour cardiac holter routine at 3, 6 and 12 months.
number of patients who have the AF risk factor within normal parameters	12 months	differences between the two groups in number of patients with BMI and/or waist circumference changes from the baseline, better score on the Minnesota Adapted Scale for Physical Exercise, number of patients who do not smoke or drink alcohol, number of patients with positive polysomnography, number of patients with impaired of the analytical parameters of HbA1c, TSH, LDL or Triglycerides.
Differences between both groups in intensity, frequency and severity of symptoms related to AF evaluated with the validated ASTA questionnaire	12 months	differences between both groups in the score obtained in the first part of the validated questionnaire in Spanish and English sensitive for patients with AF. It will be self-filled by the patient himself. It consists of 8 questions formulated in 3 different ways: (1) Multiple correct answer multiple choice questions. (2) Multiple choice questions with only one correct answer. (3) Checklist for assigning numerical values to frequency using a Likert scale from "Never = 0" to "Always = 4". Higher scores on this scale represent greater severity of symptoms.
number of participants with re-hospitalisation or emergency room visits for cardiovascular cause	12 months	differences between the two groups in number of patients who come to the emergency room or re-admit after discharge from catheter ablation.

Trial Locations

Locations (1)

Hospital Clínic; 🇪🇸 Barcelona, Spain