Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Meditation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERMental training
App-based mental training
Sponsors
Heart Center Leipzig - University Hospital
Helios Health Institute GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No
Inclusion criteria
* All patients undergoing AF ablation with symptomatic paroxysmal or chronic atrial fibrillation (EHRA II-IV) * Availability of smart phone with the capability to run android 5 or iOS 9 or newer versions * Capability to use mobile phone applications * Internet access * Consent to study participation
Exclusion criteria
* Patients \< 18 years of age * Unavailability of smart phone running at least Android 5 or iOS 9 * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Fibrillation (AF) 6 questionnaire score | 12 weeks, assessed weekly | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Fibrillation Effect on QualiTy of Life (AFEQT) score | Follow up (3 months) | 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 |
| Patient-Reported Outcome Measurement Information System (PROMIS) Global Health 10 score | Follow up (3 months) | 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. |
| Atrial fibrillation burden | Follow up (3 months) | Time in AF as assessed in 7-day-Holter |
| Heart Rate | Follow up (3 months) | Heart Rate during blood pressure measurement |
| Blood pressure | Follow up (3 months) | Office blood pressure measurement of diastolic and systolic blood pressure |
Countries
Germany
Outcome results
None listed