Bowel Preparation Quality Following Video-Based Intervention and Educational Booklet Versus Standard of Care in an Outpatient Setting (PrepVibe)

Bowel Preparation Quality Following Video-Based Intervention and Educational Booklet Versus Standard of Care in an Outpatient Setting: A Single-Center, Endoscopist-Blinded Randomized Controlled Trial

High cancellation rates and suboptimal bowel preparation increase patient discomfort, drive economic waste, and compromise clinical outcomes. Despite guideline emphasis on adequate preparation quality, there is no standard on how or when instructions should be delivered. This study compares three common patient education modalities-usual care verbal counseling, written tri-lingual pamphlet, and visual media via smartphone QR code-to determine which yields the best bowel preparation quality as assessed by the Boston Bowel Preparation Scale (BBPS) in an outpatient endoscopy setting.

Study Overview

• Status: Recruiting
• Conditions: Colonoscopy; Bowel Preparation Quality; Patient Education Materials
• Intervention / Treatment: Behavioral: Verbal Counseling; Behavioral: Tri-lingual Educational Pamphlet; Behavioral: QR-Linked Instructional Videos

Detailed Description

BACKGROUND AND RATIONALE:

Non-pharmacological factors, especially the modality of patient education, may influence bowel preparation quality, yet are underexplored and likely context-dependent based on local staffing, patient characteristics, and practice norms.

STUDY DESIGN:

Prospective, single-endoscopist-blinded, three-arm randomized controlled trial (RCT) with intention-to-treat (ITT) primary analysis. Allocation 1:1:1 using computer-generated random numbers. Endoscopist and endoscopy nurses are blinded to group assignment; participants cannot be blinded due to the nature of the intervention.

SETTING:

Hospital Sibu Endoscopy Unit, Sarawak, Malaysia. Colonoscopies performed by qualified surgeons or registrars under supervision; all endoscopists undergo refresher training on Boston Bowel Preparation Scale (BBPS) scoring for consistency.

STUDY ARMS (INTERVENTIONS):

Arm A (Control): Usual care. Physician/nurse-delivered verbal instructions plus standard pharmacy instructions for bowel preparation solution (split-dose PEG 3L).

Arm B (Written): Tri-lingual (Malay/English/Chinese), plain-language educational leaflet reviewed by health literacy expert, plus brief verbal explanation. Arm C (Visual): Short, structured instructional videos accessible via smartphone QR code, reviewed by health literacy expert, plus brief verbal explanation.

SAMPLE SIZE AND STATISTICAL ANALYSIS:

N=324 (108 per arm). Primary analysis: Intent-to-treat chi-square test comparing adequate vs inadequate BBPS across three arms. Pairwise comparisons with Bonferroni adjustment. Multivariable logistic regression adjusts for prespecified covariates (age, sex, BMI, diabetes, education, language, constipation, study arm).

PRIMARY OUTCOME:

Adequate versus inadequate bowel preparation on Boston Bowel Preparation Scale (BBPS). Adequate = total ≥6 with all segments ≥2.

SECONDARY OUTCOMES:

Polyp detection rate; cecal intubation and withdrawal times; cancellation and repeat rates; patient tolerance; complications; patient-reported clarity and helpfulness; anxiety (VAS-A); demographic predictors.

• Study Type: Interventional
• Enrollment (Estimated): 324
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prasad Mothayapan, MD; Phone Number: +60-84-343333; Email: mprasad.ge@gmail.com

Study Locations

• Malaysia
  • Sarawak
    • Sibu, Sarawak, Malaysia, 96000
      • Recruiting
      • Hospital Sibu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older
• Outpatients scheduled for elective colonoscopy at Hospital Sibu Endoscopy Unit
• Ability to provide written informed consent
• Access to smartphone or computer with functional internet connectivity

Exclusion Criteria:

• History of non-compliance with prescribed medical regimens
• Cognitive impairment, dementia, or significant mental health disorder compromising informed consent
• Illiteracy or inability to read materials in provided languages
• Prior colonic resection or colostomy
• Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS)
• Significant physical disability (bed-bound or wheelchair-dependent)
• Contraindication to polyethylene glycol (PEG) bowel preparation
• Severe Chronic Kidney Disease (Stage IV or V; eGFR <15 mL/min/1.73m²)
• Significant cardiac comorbidities (unstable angina, severe heart failure, MI within 6 months)
• Inability or unwillingness to comply with study protocol
• Refusal to provide informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care (Verbal Counseling); Standard physician/nurse-delivered verbal instructions and standard pharmacy information sheet for bowel preparation solution (split-dose PEG 3L, Fortrans) according to hospital protocol. Timing and dietary guidance aligned with standard of care. No additional written or visual materials provided.	Behavioral: Verbal Counseling; Standard verbal instructions delivered by physician or nurse regarding bowel preparation regimen, timing, dietary restrictions, and what to expect during procedure.
Experimental: Written Educational Pamphlet; Tri-lingual (Malay, English, Chinese) plain-language educational pamphlet detailing step-by-step bowel preparation instructions, plus brief verbal explanation. Pamphlet reviewed by health literacy expert prior to use. Same preparation solution and regimen as Control arm.	Behavioral: Tri-lingual Educational Pamphlet; Structured written educational material in Malay, English, and Chinese languages detailing complete bowel preparation instructions, timing, dietary guidance, what to expect, and troubleshooting tips. Provided to participant with brief verbal explanation.
Experimental: Visual Media (QR Code Video); Short, structured instructional videos accessible via smartphone QR code explaining bowel preparation procedure step-by-step, plus brief verbal explanation. Videos reviewed by health literacy expert prior to use. Same preparation solution and regimen as Control arm.	Behavioral: QR-Linked Instructional Videos; Short, professionally produced instructional videos accessible via smartphone QR code link. Videos present step-by-step bowel preparation instructions, timing, dietary guidance, common concerns, and what to expect during procedure. Participant scans QR code to access video(s) on their smartphone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate Bowel Preparation on Boston Bowel Preparation Scale (BBPS)	Primary outcome dichotomized as adequate versus inadequate bowel preparation. Adequate = total BBPS score ≥6 with all three colon segments (left, transverse, right) scoring ≥2 each (scale 0-3 per segment; range 0-9). Inadequate = total <6 or any segment <2. Assessment performed before any bowel cleansing/lavage.	On day of colonoscopy procedure, assessed immediately upon colonoscope insertion before lavage (time point: 0 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyp Detection Rate	Proportion of participants with at least one polyp detected during colonoscopy. Documented as yes/no and number of polyps.	During colonoscopy procedure
Cecal Intubation Time	Time in minutes from colonoscope insertion to identification of cecal landmarks.	During colonoscopy procedure
Colonoscopy Withdrawal Time	Time in minutes from initiation of scope withdrawal to scope exit at rectum, excluding biopsy/therapeutic time.	During colonoscopy procedure
Procedure Cancellation Rate	Proportion of participants whose colonoscopy was cancelled and reason for cancellation.	On day of scheduled colonoscopy
Repeat Colonoscopy Rate	Proportion requiring repeat colonoscopy due to inadequate initial preparation.	Within 6 months of initial colonoscopy
Patient Tolerance to Bowel Preparation	atient self-reported tolerability using five-point scale: Very Easy, Easy, Neutral, Difficult, Very Difficult.	Pre-procedure on day of colonoscopy
Procedure-Related Complications	Occurrence of perforation, bleeding, post-polypectomy syndrome, or other adverse events.	During procedure and within 7 days post-procedure
Patient-Reported Clarity of Instructions	Patient perception of clarity using five-point Likert scale. Statement: "The instructions were clear."	Pre-procedure on day of colonoscopy
Patient Anxiety Assessment	Patient self-reported anxiety on Visual Analog Scale for Anxiety (VAS-A), 0-10 scale (0=no anxiety, 10=extremely anxious).	Pre-procedure on day of colonoscopy

Collaborators and Investigators

• Sponsor: Sibu Hospital
• Investigators: Principal Investigator: Prasad Mothayapan, MD, Hospital Sibu, Malaysia; Study Director: Tiong How Chieng, MD, Hospital Sibu, Malaysia

Publications and helpful links

Helpful Links

• Colonoscopy preparation videos

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: patient education; colonoscopy; polyp detection; Boston Bowel Preparation Scale; bowel preparation quality; video-based intervention; written educational materials; endoscopy quality
• Other Study ID Numbers: RSCH-25-05992-BBX; NMRR-25-04038-EOB (Registry Identifier: Malaysian National Medical Research Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data will not be made publicly available. De-identified aggregate study data may be available upon reasonable request after publication, subject to institutional approval.

Drug and device information, study documents

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