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

Atrial Fibrillation Clinical Trial

— NURSECAT-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333445
• Other study ID #: NURSECAT-AF
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: April 30, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Other:
• usual care
standard care

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	calls and emails received	Quantify the calls and emails received from patients to the FA nurse.	12 months