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OpenTrials
Completed

NCT Number: NCT05333445

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic

Barcelona, barcelona, 08028, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

educational program

Behavioral

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

risk factors management

Behavioral

identify risk factors and offer guidance based on management strategies for the specific risk factor in each case

telephone and e-mail contact

Behavioral

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.

Usual Care

Other

standard care

Primary outcomes

  1. 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 .

    Time frame: 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 outcomes

  1. number of patients who have the AF risk factor within normal parameters

    Time frame: 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.

  2. number of participants with re-hospitalisation or emergency room visits for cardiovascular cause

    Time frame: 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.

  3. number of participants with recurrences at AF rhythm

    Time frame: 12 months

    number of AF detected by ECG or 24-hour cardiac holter routine at 3, 6 and 12 months.

  4. differences between both groups in the score received by the patients in the User Experience Questionnaire based on the Picker-33 Patient Experience Questionnaire

    Time frame: 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

  5. Differences between both groups in intensity, frequency and severity of symptoms related to AF evaluated with the validated ASTA questionnaire

    Time frame: 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.

  6. differences between both groups in the score obtained in the adapted AFKAT questionnaire patient's knowledge of AF.

    Time frame: 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.

  7. calls and emails received

    Time frame: 12 months

    Quantify the calls and emails received from patients to the FA nurse.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Acronym: NURSECAT-AF

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2022
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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