Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation

The aim is to investigate whether optimizing patients' expectations towards the interventional treatment of atrial fibrillation (catheter ablation) leads to a lower disease-related impairment of the patients compared to the control group in the first three months after ablation (the so-called blanking period).

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Expectation optimization

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westfalia
    • Düsseldorf, North Rhine-Westfalia, Germany, 40217
      • Recruiting
      • Evangelic Hospital Düsseldorf
      • Sub-Investigator: Kristin Risse, MD
      • Sub-Investigator: Wafaisade Bahram, MD
      • Sub-Investigator: Reißmann Ioana, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• symptomatic atrial fibrillation
• indication for pulmonary vein isolation
• sufficient command of the German language

Exclusion Criteria:

• age <18 years
• permanent atrial fibrillation
• presence of psychiatric disorders which impair the study participitatin
• presence of another medical condiction which influences quality of life stronger than the cardiac condition
• atrial fibrillation induced by intoxication, medicamentation or infection
• inability to grap the course of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Medical Care Control Group; Patients with atrial fibrillation receiving catheter ablation of atrial fibrillation without additional intervention.
Experimental: Optimize Expectation Group; Patients with atrial fibrillation receiving catheter ablation of atrial fibrillation and an additional verbal intervention to optimize the expectation of the patient towards the procedure.	Other: Expectation optimization; A short (2-5 min) verbal intervention will be createad individually based on the expectation of the patient towards the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (questionaire)	Quality of life of life will be compared between groups and between different time points (before versus 3 months after ablation) with "the atrial fibrillation effect on quality-of-life (AFEQT) questionnaire". An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in AF symptoms.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of atrial arrhythmias	Electrocardiographic documentation of any atrial arrhythmia with a duration >30 sec	3 months
Recurrence of atrial arrhythmias	Electrocardiographic documentation of any atrial arrhythmia with a duration >30 sec	12 months
Autonomic function (heart rate variability measurement)	Autonomic function will be assessed by heart rate variability measurement (low frequency and high frequency domain, root mean square of successive differences) to compare patients between groups and time points (before versus 3 months after ablation)	3 months
Atrial volume [ml/m2]	Atrial volume measured via echocardiography will be compared between groups and time points (before versus 3 months after ablation)	3 months
Left ventricular ejection fraction [%]	Left ventricular ejection fraction measured via echocardiography will be compared between groups and between time points (before versus 3 months after ablation)	3 months
Inflammatory markers from blood samples	Inflammatory markers (including IFN-gamma, TNF-alpha TGF-beta, IL-1beta, IL-4, IL-6, IL-8, IL-10, IL-1, CRP, MPO, NGF, S100B, ANP, FABP4) in blood samples measured via enzyme-linked immunosorbent assays will be compared between groups and between time points (before versus 3 months after ablation)	3 months
Treatment expectations (questionaire)	Treatment expectations will be measured using the GEEE (Generic rating scale for previous treatment experiences, treatment expectations, and treatment effects) questionaire by Rief et al. and compared between groups and between time points (before versus 3 months after ablation / before versus 12 months after ablation). The subscale Generic rating scale for treatment expectations consists of three items that assess expectations towards treatment on a numeric rating scale with eleven response options (0-10); total scores of all three subscales combined range from 0-30 with higher scores indicating higher treatment expectations.	3 months, 12 months
Physical Activity (questionaire)	Physical activity will be measured will be compared between groups and time points (before versus 3 months after ablation) using the short version of the International Physical Activity Questionnaire (IPAQ - short). The short version of the IPAQ is a 7-item questionnaire that assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives. Open-ended questions surrounding individuals' last 7-day recall of physical activity are considered to estimate total physical activity min/week and time spent sitting. Interpretation: Three levels (categories) of physical activity are proposed: low, moderate and high.	3 months, 12 months
General quality of life (questionaire)	General quality of life of life will be compared between groups and between different time points (before versus 3 months after ablation) with "F-36 questionaire. SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.	3 months, 12 months
Hospital Anxiety and Depression Scale HADS (questionaire)	Hospital anxiety and depression will becompared between groups and time points (before versus 3 months after ablation) using the Hospital Anxiety and Depression Scale (HADS). It consists of 14 items rated zero to three on Likert scales, allowing computation of sub-scores for depression and anxiety symptoms. Subscores as well as total sum score will be applied.	3 months, 12 months
Cardiac Anxiety Questionnaire CAQ (questionaire)	Cardiac anxiety will becompared between groups and time points (before versus 3 months after ablation) using the established Cardiac Anxiety Questionnaire CAQ to determine cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 68 for the German version, with a greater score indicating elevated cardiac anxiety.	3 months, 12 months

Collaborators and Investigators

• Sponsor: Evangelical Hospital Düsseldorf
• Collaborators: University Hospital, Essen

Publications and helpful links

General Publications

• Rief W, Shedden-Mora MC, Laferton JA, Auer C, Petrie KJ, Salzmann S, Schedlowski M, Moosdorf R. Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial. BMC Med. 2017 Jan 10;15(1):4. doi: 10.1186/s12916-016-0767-3.
• Salzmann S, Euteneuer F, Laferton JAC, Auer CJ, Shedden-Mora MC, Schedlowski M, Moosdorf R, Rief W. Effects of Preoperative Psychological Interventions on Catecholamine and Cortisol Levels After Surgery in Coronary Artery Bypass Graft Patients: The Randomized Controlled PSY-HEART Trial. Psychosom Med. 2017 Sep;79(7):806-814. doi: 10.1097/PSY.0000000000000483.
• Schedlowski M, Enck P, Rief W, Bingel U. Neuro-Bio-Behavioral Mechanisms of Placebo and Nocebo Responses: Implications for Clinical Trials and Clinical Practice. Pharmacol Rev. 2015 Jul;67(3):697-730. doi: 10.1124/pr.114.009423.
• Laferton JA, Auer CJ, Shedden-Mora MC, Moosdorf R, Rief W. Optimizing preoperative expectations in cardiac surgery patients is moderated by level of disability: the successful development of a brief psychological intervention. Psychol Health Med. 2016;21(3):272-85. doi: 10.1080/13548506.2015.1051063. Epub 2015 Jun 4.
• Kuniss M, Pavlovic N, Velagic V, Hermida JS, Healey S, Arena G, Badenco N, Meyer C, Chen J, Iacopino S, Anselme F, Packer DL, Pitschner HF, Asmundis C, Willems S, Di Piazza F, Becker D, Chierchia GB; Cryo-FIRST Investigators. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. Europace. 2021 Jul 18;23(7):1033-1041. doi: 10.1093/europace/euab029.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: IMPROVE AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No