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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021661

Enrollment

300

Registered

2020-10-23

Start date

2021-02-08

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I35.0

Interventions

Group 1: Standard Patient Informed Consent (official written patient IC form and discussion with a physician) and general information broschure about the hospital Group 2: Standard Patient Informed Co

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing elective TAVI, Age > 18 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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). 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.	—

Measure

Time frame

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). 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.

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Secondary

Measure	Time frame
1. The additional use of medical graphic narratives (patient comic) has beneficial effects on patient satisfaction with the IC procedure. Patient satisfaction is tested by using the validated Client Satisfaction Questionnaire-8 (CSQ-8) after completing the IC procedure. 2. The additional use of medical graphic narratives (patient comic) has beneficial effects on patient-centred parameters such as perceived comprehension of the IC contents, improved imagination with regard to the procedure and the feeling of having been adequately prepared for the intervention. Self-designed single items are used to assess these endpoints. 3. The additional use of medical graphic narratives (patient comic) reduces the incidence of post-interventional delirium after TAVI. Signs of post-interventional delirium are assessed after TAVI on days 0 to 3 using the Confusion Assessment Method for Intensive Care Units (CAM-ICU). 4. The additional use of medical graphic narratives (patient comic) has beneficial effects on Patient Reported Outcome Measures (PROMs) 90 days after TAVI. Self-designed questionnaires on the current health status with space for free comments are sent to the patients.	—

Measure

Time frame

1. The additional use of medical graphic narratives (patient comic) has beneficial effects on patient satisfaction with the IC procedure. Patient satisfaction is tested by using the validated Client Satisfaction Questionnaire-8 (CSQ-8) after completing the IC procedure. 2. The additional use of medical graphic narratives (patient comic) has beneficial effects on patient-centred parameters such as perceived comprehension of the IC contents, improved imagination with regard to the procedure and the feeling of having been adequately prepared for the intervention. Self-designed single items are used to assess these endpoints. 3. The additional use of medical graphic narratives (patient comic) reduces the incidence of post-interventional delirium after TAVI. Signs of post-interventional delirium are assessed after TAVI on days 0 to 3 using the Confusion Assessment Method for Intensive Care Units (CAM-ICU). 4. The additional use of medical graphic narratives (patient comic) has beneficial effects on Patient Reported Outcome Measures (PROMs) 90 days after TAVI. Self-designed questionnaires on the current health status with space for free comments are sent to the patients.

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Countries

Germany

Contacts

Public ContactAnna Brand

Charité - Universitätsmedizin Berlin, Department of Cardiology and Angiology, Campus Charité Mitte

anna.brand@charite.de+49 30 450 513 142

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026