Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients

NCT07155603 | Not Yet Recruiting DMC

• 1 other identifier: 2024-01572
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Effective communication in healthcare is critical for improving patient outcomes, particularly in enhancing health literacy and enabling informed decision-making. Traditional informed consent for colonoscopy often fails to clearly explain the procedure, risks, and preparation requirements, leading to inadequate bowel preparation, longer procedures, and missed lesions. Standard educational materials like videos and written instructions are often impersonal, lack cultural inclusivity, and fail to engage patients effectively. Emerging tools, such as the multilingual, visually enhanced Meine Behandlung video series from Visikon®, aim to improve patient comprehension and adherence. This study seeks to compare the effectiveness of these animated videos against traditional consent methods in enhancing patient understanding and adherence, particularly for complex procedures like colonoscopy, which is crucial for diagnosing and preventing colorectal cancer.

Conditions

The Effect of Audio-visual Aids on Bowel Cleanliness; Audiovisual Aids

Outcome Measures

Primary Outcomes (1)

• Bowel Preperation

  The objective of assessing the primary endpoint the patient's bowel cleanliness, will be measured during the routine colonoscopy, using the Boston Bowel Preperation Scale. The Boston Bowel Preparation Scale (BBPS) is a validated tool used to assess the cleanliness of the colon during a colonoscopy, Each of the three segments of the colon (right, transverse, and left) is assigned a score ranging from 0 to 3, with the following criteria: Total Score 0: The entire colon is unprepared, and no mucosa is visible. Total Score 1-3: Poor preparation, significant portions of the mucosa are not visible. Total Score 4-6: Fair preparation, with some portions of the mucosa visible but others obscured. Total Score 7-9: Good to excellent preparation, with most or all mucosa well visualized. Interpretation Scores of 0-3: Generally considered inadequate for proper assessment and diagnosis, likely requiring repeat preparation and examination. Scores of 4-6: Indicative of suboptimal preparation

  24 months

Secondary Outcomes (1)

• Patient Health Literacy & Communication Satisfaction

  24 months

Study Arms (2)

Traditional Consent (Control Group)

ACTIVE COMPARATOR

The traditional informed consent process involves the provision of written documents and verbal explanation to the patient regarding the colonoscopy procedure, risks, and preparation requirements

Behavioral: Animated Video Group 1

Animated Video 1

EXPERIMENTAL

Patients of this group will be asked to watch the Visikon animated videos, in addition to receiving standard informed consent

Behavioral: Animated Video Group 1

Interventions

Animated Video Group 1 BEHAVIORAL

The animated video intervention provides a clear and engaging multimedia explanation of the colonoscopy procedure in multiple languages. It includes visual aids to help explain the process, preparation instructions, risks, and expected outcomes, aiming to improve patient comprehension and adherence.

Animated Video 1; Traditional Consent (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Scheduled for a routine outpatient colonoscopy procedure
• Capable of understanding communication in German and willing to participate in the study

You may not qualify if:

• Patients with cognitive impairments
• Those unwilling to participate

Sponsors & Collaborators

• Prof. Dr. Jörg Leuppi: lead

Study Sites (1)

Cantonal Hospital of Baselland

Liestal, 4410, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Jörg Daniel Leuppi

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: September 4, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): December 15, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-09

Locations

CH (1)