NCT05333445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

March 7, 2025

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

March 25, 2022

Last Update Submit

March 5, 2025

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationnurse-lededucational interventionrisk factorsquality of life

Outcome Measures

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 .

    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 Outcomes (7)

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

    12 months

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

    12 months

  • number of participants with recurrences at AF rhythm

    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

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

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Nursing intervention

EXPERIMENTAL

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 programBehavioral: risk factors managementBehavioral: telephone and e-mail contact

control group

ACTIVE COMPARATOR

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

Interventions

educational programBEHAVIORAL

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

Nursing intervention
risk factors managementBEHAVIORAL

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

Nursing intervention
telephone and e-mail contactBEHAVIORAL

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.

Nursing intervention
usual careOTHER

standard care

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic

Barcelona, barcelona, 08028, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Arrythmia Unit

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 19, 2022

Study Start

April 15, 2022

Primary Completion

March 1, 2024

Study Completion

April 30, 2024

Last Updated

March 7, 2025

Record last verified: 2024-01

Locations

ES(1)