Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Expectation optimization
Sponsored by
About this trial
This is an interventional supportive care trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- Evangelic Hospital DüsseldorfRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Medical Care Control Group
Optimize Expectation Group
Arm Description
Patients with atrial fibrillation receiving catheter ablation of atrial fibrillation without additional intervention.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Recurrence of atrial arrhythmias
Electrocardiographic documentation of any atrial arrhythmia with a duration >30 sec
Recurrence of atrial arrhythmias
Electrocardiographic documentation of any atrial arrhythmia with a duration >30 sec
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)
Atrial volume [ml/m2]
Atrial volume measured via echocardiography will be compared between groups and time points (before versus 3 months after ablation)
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)
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)
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05557526
First Posted
January 7, 2022
Last Updated
November 9, 2022
Sponsor
Evangelical Hospital Düsseldorf
Collaborators
University Hospital, Essen
1. Study Identification
Unique Protocol Identification Number
NCT05557526
Brief Title
Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation
Official Title
Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Evangelical Hospital Düsseldorf
Collaborators
University Hospital, Essen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Medical Care Control Group
Arm Type
No Intervention
Arm Description
Patients with atrial fibrillation receiving catheter ablation of atrial fibrillation without additional intervention.
Arm Title
Optimize Expectation Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Expectation optimization
Intervention Description
A short (2-5 min) verbal intervention will be createad individually based on the expectation of the patient towards the procedure.
Primary Outcome Measure Information:
Title
Quality of life (questionaire)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Recurrence of atrial arrhythmias
Description
Electrocardiographic documentation of any atrial arrhythmia with a duration >30 sec
Time Frame
3 months
Title
Recurrence of atrial arrhythmias
Description
Electrocardiographic documentation of any atrial arrhythmia with a duration >30 sec
Time Frame
12 months
Title
Autonomic function (heart rate variability measurement)
Description
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)
Time Frame
3 months
Title
Atrial volume [ml/m2]
Description
Atrial volume measured via echocardiography will be compared between groups and time points (before versus 3 months after ablation)
Time Frame
3 months
Title
Left ventricular ejection fraction [%]
Description
Left ventricular ejection fraction measured via echocardiography will be compared between groups and between time points (before versus 3 months after ablation)
Time Frame
3 months
Title
Inflammatory markers from blood samples
Description
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)
Time Frame
3 months
Title
Treatment expectations (questionaire)
Description
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.
Time Frame
3 months, 12 months
Title
Physical Activity (questionaire)
Description
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.
Time Frame
3 months, 12 months
Title
General quality of life (questionaire)
Description
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.
Time Frame
3 months, 12 months
Title
Hospital Anxiety and Depression Scale HADS (questionaire)
Description
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.
Time Frame
3 months, 12 months
Title
Cardiac Anxiety Questionnaire CAQ (questionaire)
Description
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.
Time Frame
3 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Evangelic Hospital Düsseldorf
City
Düsseldorf
State/Province
North Rhine-Westfalia
ZIP/Postal Code
40217
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Meyer, MD
Phone
00492119191855
Email
christian.meyer@evk-duesseldorf.de
First Name & Middle Initial & Last Name & Degree
Katharina Scherschel, PhD
Email
katharina.scherschel@evk-duesseldorf.de
First Name & Middle Initial & Last Name & Degree
Christian Meyer, MD
First Name & Middle Initial & Last Name & Degree
Ernan Zhu, MD
First Name & Middle Initial & Last Name & Degree
Fares A Alken, MD
First Name & Middle Initial & Last Name & Degree
Kristin Risse, MD
First Name & Middle Initial & Last Name & Degree
Wafaisade Bahram, MD
First Name & Middle Initial & Last Name & Degree
Reißmann Ioana, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28846584
Citation
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.
Results Reference
background
PubMed Identifier
28069021
Citation
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.
Results Reference
background
PubMed Identifier
26126649
Citation
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.
Results Reference
background
PubMed Identifier
26042657
Citation
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.
Results Reference
background
PubMed Identifier
33728429
Citation
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.
Results Reference
background
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Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation
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