NURSE-led Follow-up in Patients Undergoing CATheter Ablation for Atrial Fibrillation (NURSECAT-AF)

Assessing the Nurse-led Educational Intervention in Patients Undergoing Catheter Ablation for Atrial Fibrillation: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Behavioral: educational program; Behavioral: risk factors management; Behavioral: telephone and e-mail contact; Other: usual care

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • Recruiting
    • Hospital Clínic
    • Contact: Lluis Mont, MD, PhD; Phone Number: +34932275551; Email: lmont@clinic.cat
    • Sub-Investigator: Alba Cano Valls, RN, MSc
    • Sub-Investigator: Eduard Guasch, MD PhD
    • Sub-Investigator: Esther Carro, RN MSc
    • Sub-Investigator: Jose Luis Puente, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nursing intervention; 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.	Behavioral: educational program; Education for the management of AF is carried out in a structured way, following the Bowyer model using the following pre-specified subtitles: "How the heart works"; "Causes and risk factors of AF"; "Symptoms of AF";"" Goals of treatment in atrial fibrillation ""; ''preparation for the ablation procedure''; and "Lifestyle Modification". The technique consists of discussing the main subtitles and adapting the visit line to the needs of each patient; Behavioral: risk factors management; identify risk factors and offer guidance based on management strategies for the specific risk factor in each case; Behavioral: telephone and e-mail contact; patients will also be provided with a phone number and email to contact the nurse for any concerns outside the designated times within the twelve-month follow-up.
Active Comparator: control group; 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.	Other: usual care; standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients who have the AF risk factor within normal parameters	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.	12 months
number of participants with re-hospitalisation or emergency room visits for cardiovascular cause	differences between the two groups in number of patients who come to the emergency room or re-admit after discharge from catheter ablation.	12 months
number of participants with recurrences at AF rhythm	number of AF detected by ECG or 24-hour cardiac holter routine at 3, 6 and 12 months.	12 months
differences between both groups in the score received by the patients in the User Experience Questionnaire based on the Picker-33 Patient Experience Questionnaire	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	3 months
Differences between both groups in intensity, frequency and severity of symptoms related to AF evaluated with the validated ASTA questionnaire	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.	12 months
differences between both groups in the score obtained in the adapted AFKAT questionnaire patient's knowledge of AF.	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.	3 months
calls and emails received	Quantify the calls and emails received from patients to the FA nurse.	12 months

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; atrial fibrillation; risk factors; educational intervention; nurse-led
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: NURSECAT-AF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No