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

6 juli 2026 bijgewerkt door: Sibu Hospital

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

324

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Maleisië
    • Sarawak
      • Sibu, Sarawak, Maleisië, 96000
        • Werving
        • Hospital Sibu

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: Verbal Counseling
Standard verbal instructions delivered by physician or nurse regarding bowel preparation regimen, timing, dietary restrictions, and what to expect during procedure.
Experimenteel: 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.
Gedragsmatig: 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.
Experimenteel: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adequate Bowel Preparation on Boston Bowel Preparation Scale (BBPS)
Tijdsspanne: On day of colonoscopy procedure, assessed immediately upon colonoscope insertion before lavage (time point: 0 minutes)
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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Polyp Detection Rate
Tijdsspanne: During colonoscopy procedure
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
Tijdsspanne: During colonoscopy procedure
Time in minutes from colonoscope insertion to identification of cecal landmarks.
During colonoscopy procedure
Colonoscopy Withdrawal Time
Tijdsspanne: During colonoscopy procedure
Time in minutes from initiation of scope withdrawal to scope exit at rectum, excluding biopsy/therapeutic time.
During colonoscopy procedure
Procedure Cancellation Rate
Tijdsspanne: On day of scheduled colonoscopy
Proportion of participants whose colonoscopy was cancelled and reason for cancellation.
On day of scheduled colonoscopy
Repeat Colonoscopy Rate
Tijdsspanne: Within 6 months of initial colonoscopy
Proportion requiring repeat colonoscopy due to inadequate initial preparation.
Within 6 months of initial colonoscopy
Patient Tolerance to Bowel Preparation
Tijdsspanne: Pre-procedure on day of colonoscopy
atient self-reported tolerability using five-point scale: Very Easy, Easy, Neutral, Difficult, Very Difficult.
Pre-procedure on day of colonoscopy
Patient Anxiety Assessment
Tijdsspanne: Pre-procedure on day of colonoscopy
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
Procedure-Related Complications
Tijdsspanne: During procedure and within 7 days post-procedure
Occurrence of procedure-related complications including perforation, bleeding, post-polypectomy syndrome, or other adverse events. Outcome is dichotomous: Yes (complication occurred) or No (no complications). Lower occurrence rate indicates better outcome.
During procedure and within 7 days post-procedure
Patient-Reported Clarity of Instructions
Tijdsspanne: Pre-procedure on day of colonoscopy
Patient perception of clarity using Five-Point Likert Scale (minimum=1 "Strongly Disagree", maximum=5 "Strongly Agree"). Statement: "The instructions were clear." Higher scores indicate greater perceived clarity of instructions (better outcome).
Pre-procedure on day of colonoscopy

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sibu Hospital

Onderzoekers

  • Hoofdonderzoeker: Prasad Mothayapan, MD, Hospital Sibu, Malaysia
  • Studie directeur: Tiong How Chieng, MD, Hospital Sibu, Malaysia

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2026

Primaire voltooiing (Geschat)

31 augustus 2026

Studie voltooiing (Geschat)

31 augustus 2026

Studieregistratiedata

Eerst ingediend

29 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 juni 2026

Eerst geplaatst (Werkelijk)

6 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

6 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • RSCH-25-05992-BBX
  • NMRR-25-04038-EOB (Register-ID: Malaysian National Medical Research Registry)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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