Medical graphic narratives to improve patient comprehension and periprocedural anxiety before Transcatheter Aortic Valve Implantation: a randomized trial

Not Applicable

• Conditions: I35.0; Aortic (valve) stenosis

• Registration Number: DRKS00021661
• Lead Sponsor: Charité - Universitätsmedizin Berlin, Department of Cardiology and Angiology, Campus Charité Mitte; Cardiovascular Core Unit (CVCU), Campus Virchow Klinikum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-23
• Study Completion: 2021-11-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 303

Inclusion Criteria

Patients undergoing elective TAVI,
Age > 18 years

Exclusion Criteria

Insufficient German language skills,
Advanced cognitive dysfunction (f.e. dementia syndrome)
Relevant psychiatric dysorders
Lack of patient consent to study participation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The additional use of medical graphic narratives (patient comic) shows beneficial effects on patient comprehension of the patient IC contents; patients with mildly impaired cognitive function in particular benefit from the additional patient comic. After the IC procedure has been completed, patient comprehension is tested in both patient groups using a self-designed multiple choice test consisting of 14 items (three possible answers each, evaluated as correct/incorrect), assessing individual aspects of the patient IC content (procedural details, behavioral measures, risks and treatment alternatives). Cognitive function is tested prior to patient IC using the Montreal Cognitive Assessment (MoCA).<br>2. The additional use of medical graphic narratives (patient comic) leads to a reduction in periprocedural anxiety. Periprocedural state anxiety is tested by using the Spielberg State-Trait Anxiety Inventory (STAI) before and after the patient IC in both groups.