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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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

324

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Malaysia
    • Sarawak
      • Sibu, Sarawak, Malaysia, 96000
        • Rekruttering
        • Hospital Sibu

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Atferdsmessig: Verbal Counseling
Standard verbal instructions delivered by physician or nurse regarding bowel preparation regimen, timing, dietary restrictions, and what to expect during procedure.
Eksperimentell: 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.
Atferdsmessig: 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.
Eksperimentell: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adequate Bowel Preparation on Boston Bowel Preparation Scale (BBPS)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Polyp Detection Rate
Tidsramme: 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
Tidsramme: During colonoscopy procedure
Time in minutes from colonoscope insertion to identification of cecal landmarks.
During colonoscopy procedure
Colonoscopy Withdrawal Time
Tidsramme: 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
Tidsramme: On day of scheduled colonoscopy
Proportion of participants whose colonoscopy was cancelled and reason for cancellation.
On day of scheduled colonoscopy
Repeat Colonoscopy Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sibu Hospital

Etterforskere

  • Hovedetterforsker: Prasad Mothayapan, MD, Hospital Sibu, Malaysia
  • Studieleder: Tiong How Chieng, MD, Hospital Sibu, Malaysia

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2026

Primær fullføring (Antatt)

31. august 2026

Studiet fullført (Antatt)

31. august 2026

Datoer for studieregistrering

Først innsendt

29. juni 2026

Først innsendt som oppfylte QC-kriteriene

29. juni 2026

Først lagt ut (Faktiske)

6. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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