Atrial fibrillation (AF) is one of the most common heart rhythm disorders and it is associated with a variety of symptoms leading to a considerable deterioration in quality of life. The Mental-AF trial is intended to inquire if an app-based mental training can reduce the occurrence of symptomatic AF episodes within the blanking period, i.e. the first three months after catheter ablation for AF.
To explore the potential of a daily app-based mindfulness mental training in improving AF symptoms, assessed by self-reported outcome measures, i.e. the AF 6 questionnaire, AF Effect on QualiTy of Life (AFEQT) and Patient Reported Outcome Measurement Information System (PROMIS) Global Health questionnaires, as well as in reducing AF burden in 7-day-Holter, within the first 12 weeks following AF ablation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
183
App-based mental training
Leipzig Heart Institute
Leipzig, Saxony, Germany
Atrial Fibrillation (AF) 6 questionnaire score
Atrial fibrillation specific symptomatic outcome defined by AF 6 sum scores during the first 12 weeks following AF ablation, based on a 10-point Likert scale, ranging from 0 (no symptoms) to 10 (severe symptoms), sum scores ranging from 0 to 60.
Time frame: 12 weeks, assessed weekly
Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score
Effects of AF on quality of Life, assessed by a 20-item questionnaire with 4 conceptual domains (daily Activities, treatment concern, symptoms and treatment satisfaction) on a 7-point Likert scale, responses ranging from 1 (no symptoms/limitations) to 7 (most severe limitations/symptoms), higher scores indicating better health status, the raw scores can be transformed to a 0 to 100 scale adjusting for missing data
Time frame: Follow up (3 months)
Patient-Reported Outcome Measurement Information System (PROMIS) Global Health 10 score
PROMIS Global Health questionnaire for the assessment of physical and mental health domains by 10 items using a 5-point Likert scale, ranging from (5) excellent to (1) poor. Higher scores indicate a healthier patient.
Time frame: Follow up (3 months)
Atrial fibrillation burden
Time in AF as assessed in 7-day-Holter
Time frame: Follow up (3 months)
Heart Rate
Heart Rate during blood pressure measurement
Time frame: Follow up (3 months)
Blood pressure
Office blood pressure measurement of diastolic and systolic blood pressure
Time frame: Follow up (3 months)
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Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score
Effects of AF on quality of Life, assessed by a 20-item questionnaire with 4 conceptual domains (daily Activities, treatment concern, symptoms and treatment satisfaction) on a 7-point Likert scale, responses ranging from 1 (no symptoms/limitations) to 7 (most severe limitations/symptoms), higher scores indicating better health status, the raw scores can be transformed to a 0 to 100 scale adjusting for missing data
Time frame: Follow up at 12 months