NURSE-CAT: NURSE-led Follow-up in Patients Undergoing Catheter Ablation for ATrial Fibrillation

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Recruiting

CT.gov ID

NCT05333445

Collaborator

(none)

Enrollment

Location

Arms

24.5

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Behavioral: educational program Behavioral: risk factors management Behavioral: telephone and e-mail contact Other: usual care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Impact of Nurse-led Follow-up on the Quality of Life of Patients Undergoing Catheter Ablation for Atrial Fibrillation: a Randomised Controlled Trial

Actual Study Start Date :

Apr 15, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
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
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.