Back to resultsNURSE-led Follow-up in Patients Undergoing CATheter Ablation for Atrial Fibrillation (NURSECAT-AF)
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
educational program
risk factors management
telephone and e-mail contact
usual care
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, nurse-led, educational intervention, risk factors, quality of life
Eligibility Criteria
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.
Sites / Locations
- Hospital ClínicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nursing intervention
control group
Arm Description
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.
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.
Outcomes
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 .
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
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
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
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
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
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.
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
Quantify the calls and emails received from patients to the FA nurse.
Full Information
NCT ID
NCT05333445
First Posted
March 25, 2022
Last Updated
July 17, 2023
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT05333445
Brief Title
NURSE-led Follow-up in Patients Undergoing CATheter Ablation for Atrial Fibrillation
Acronym
NURSECAT-AF
Official Title
Assessing the Nurse-led Educational Intervention in Patients Undergoing Catheter Ablation for Atrial Fibrillation: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, nurse-led, educational intervention, risk factors, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nursing intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
educational program
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
risk factors management
Intervention Description
identify risk factors and offer guidance based on management strategies for the specific risk factor in each case
Intervention Type
Behavioral
Intervention Name(s)
telephone and e-mail contact
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
standard care
Primary Outcome Measure Information:
Title
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 .
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
number of patients who have the AF risk factor within normal parameters
Description
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.
Time Frame
12 months
Title
number of participants with re-hospitalisation or emergency room visits for cardiovascular cause
Description
differences between the two groups in number of patients who come to the emergency room or re-admit after discharge from catheter ablation.
Time Frame
12 months
Title
number of participants with recurrences at AF rhythm
Description
number of AF detected by ECG or 24-hour cardiac holter routine at 3, 6 and 12 months.
Time Frame
12 months
Title
differences between both groups in the score received by the patients in the User Experience Questionnaire based on the Picker-33 Patient Experience Questionnaire
Description
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
Time Frame
3 months
Title
Differences between both groups in intensity, frequency and severity of symptoms related to AF evaluated with the validated ASTA questionnaire
Description
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.
Time Frame
12 months
Title
differences between both groups in the score obtained in the adapted AFKAT questionnaire patient's knowledge of AF.
Description
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.
Time Frame
3 months
Title
calls and emails received
Description
Quantify the calls and emails received from patients to the FA nurse.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Clínic
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lluis Mont, MD, PhD
Phone
+34932275551
Email
lmont@clinic.cat
First Name & Middle Initial & Last Name & Degree
Alba Cano Valls, RN, MSc
First Name & Middle Initial & Last Name & Degree
Eduard Guasch, MD PhD
First Name & Middle Initial & Last Name & Degree
Esther Carro, RN MSc
First Name & Middle Initial & Last Name & Degree
Jose Luis Puente, MD
12. IPD Sharing Statement
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NURSE-led Follow-up in Patients Undergoing CATheter Ablation for Atrial Fibrillation
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