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

2026年6月29日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

324

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • マレーシア
    • Sarawak
      • Sibu、Sarawak、マレーシア、96000
        • 募集
        • Hospital Sibu

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
行動：Verbal Counseling
Standard verbal instructions delivered by physician or nurse regarding bowel preparation regimen, timing, dietary restrictions, and what to expect during procedure.
実験的：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.
行動：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.
実験的：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.
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Adequate Bowel Preparation on Boston Bowel Preparation Scale (BBPS)
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Polyp Detection Rate
時間枠：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
時間枠：During colonoscopy procedure
Time in minutes from colonoscope insertion to identification of cecal landmarks.
During colonoscopy procedure
Colonoscopy Withdrawal Time
時間枠：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
時間枠：On day of scheduled colonoscopy
Proportion of participants whose colonoscopy was cancelled and reason for cancellation.
On day of scheduled colonoscopy
Repeat Colonoscopy Rate
時間枠：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
時間枠：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
Procedure-Related Complications
時間枠：During procedure and within 7 days post-procedure
Occurrence of perforation, bleeding, post-polypectomy syndrome, or other adverse events.
During procedure and within 7 days post-procedure
Patient-Reported Clarity of Instructions
時間枠：Pre-procedure on day of colonoscopy
Patient perception of clarity using five-point Likert scale. Statement: "The instructions were clear."
Pre-procedure on day of colonoscopy
Patient Anxiety Assessment
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Sibu Hospital

捜査官

  • 主任研究者：Prasad Mothayapan, MD、Hospital Sibu, Malaysia
  • スタディディレクター：Tiong How Chieng, MD、Hospital Sibu, Malaysia

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年3月1日

一次修了 (推定)

2026年8月31日

研究の完了 (推定)

2026年8月31日

試験登録日

最初に提出

2026年6月29日

QC基準を満たした最初の提出物

2026年6月29日

最初の投稿 (実際)

2026年7月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月6日

QC基準を満たした最後の更新が送信されました

2026年6月29日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • RSCH-25-05992-BBX
  • NMRR-25-04038-EOB (レジストリ識別子：Malaysian National Medical Research Registry)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

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いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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