Individualized Non-pharmacological Intervention for Bowel Preparation
1. Juli 2026 aktualisiert von: Xingshun Qi, General Hospital of Shenyang Military Region
Effect of an Individualized Non-pharmacological Intervention Based on a Predictive Model for Inadequate Bowel Preparation on Bowel Preparation Quality: a Three-arm, Prospective, Randomized Controlled Study
Colonoscopy is essential for the early detection of colorectal cancer.
However, inadequate bowel preparation remains a common challenge, associated with reduced adenoma detection rates, prolonged procedure time, and increased healthcare costs.
Current individualized regimens rely largely on higher laxative dosages-an approach with limited clinical utility.
Non-pharmacological interventions, including dietary modification, physical activity, and health education, are safe and tend to have better patient adherence.
The effectiveness of health education depends largely on message framing.
Guided by information-framing theory, we developed an individualized non-pharmacological regimen.
This randomized controlled trial aims to evaluate the efficacy of this regimen in improving bowel preparation quality.
Studienübersicht
Status
Rekrutierung
Bedingungen
Detaillierte Beschreibung
A total of 339 patients are enrolled and randomly assigned in a 1:1:1 ratio to the information-framing + individualized bowel preparation (BP) group, the individualized BP group, and the control group.
All patients receive oral instructions on bowel preparation.
On this basis, the control group receives a standard BP regimen and written educational materials; the individualized BP group is assessed using a risk prediction model for inadequate bowel preparation, with the results disclosed to the patients.
Those with a risk score ≥3.25 receive an enhanced BP regimen, while those with a risk score <3.25 receive the standard BP regimen, and all patients in this group receive illustrated educational materials.
In the information-framing + individualized BP group, educational materials are further tailored according to the information framework theory.
Specifically, patients with a risk score ≥3.25 receive loss-framed materials emphasizing the harms of non-adherence, whereas those with a score <3.25 receive gain-framed materials highlighting the benefits of adherence.
On the day of the colonoscopy, patients' willingness to undergo a repeat colonoscopy and the occurrence of adverse events are recorded in the waiting area.
Patients also complete the Bowel Preparation Adherence Behavior Assessment Scale and the Treatment Self-Regulation Questionnaire.
Bowel preparation quality is evaluated by endoscopists blinded to group allocation using the Boston Bowel Preparation Scale (BBPS), and polyp/adenoma detection rates are also recorded.
Studientyp
Interventionell
Einschreibung (Geschätzt)
339
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Xingshun Qi
- Telefonnummer: +8618909881019
- E-Mail: xingshunqi@126.com
Studieren Sie die Kontaktsicherung
- Name: weiyi wang
- Telefonnummer: 13019441021
- E-Mail: 373302698@qq.com
Studienorte
-
-
Liaoning
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Shenyang, Liaoning, China, 110016
- Rekrutierung
- General Hospital of Northern Theater Command
-
Kontakt:
- Xingshun Qi
- Telefonnummer: 13019441024
- E-Mail: xingshunqi@126.com
-
Kontakt:
- E-Mail: 373302698@qq.com
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- age ≥ 18 years;
- outpatient scheduled for colonoscopy using oral laxatives for bowel preparation;
- able to understand the study and provide written informed consent.
Exclusion Criteria:
- undergoing emergency colonoscopy;
- suspected intestinal obstruction, stricture, or perforation;
- severe cardiac, cerebral, hepatic, or renal disease;
- severe psychiatric disorder;
- impaired consciousness or communication difficulties;
- pregnancy or lactation;
- previous enrollment in this study.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Standard bowel preparation group
Patients receive verbal instructions and printed text-based bowel preparation education materials, along with a standard bowel preparation regimen.
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Patients receive verbal bowel preparation instruction and printed text-based bowel preparation education materials.
|
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Experimental: Individualized bowel preparation group
Patients receive verbal instructions and printed illustrated bowel preparation educational materials.
The inadequate bowel preparation risk score is calculated using the established prediction model.
Patients with a risk score ≥ 3.25 receive an enhanced bowel preparation regimen, whereas those with a score < 3.25 receive the standard bowel preparation regimen.
The enhanced bowel preparation regimen is based on the standard protocol, with two additional components.
First, starting 3 days before the colonoscopy, patients are instructed to avoid high-fiber foods and, from 1 day before the colonoscopy, to adopt a semiliquid low-residue diet.
They are also asked to walk for 30 minutes after each meal, with a target of approximately 6,000 steps per day.
Second, after consuming each 500 mL of the polyethylene glycol electrolyte solution and upon finishing the entire solution, patients are asked to chew one piece of sugar-free gum for 10 minutes.
|
Patients receive verbal instructions and printed illustrated bowel preparation educational material.
Patients with a risk score ≥ 3.25 are instructed to take low-residue diet 3 days before colonoscopy and walk for 30 minutes after each meal, with a target of approximately 6,000 steps per day.
After consuming each 500 mL of polyethylene glycol electrolyte solution, and finishing the entire solution, patients are asked to chew one piece of sugar-free gum for 10 minutes.
Patients with a score < 3.25 received the standard bowel preparation regimen.
|
|
Experimental: Information-framing guided individualized bowel preparation group
Patients receive the same interventions as those in the individualized group.
In addition, they receive information-framed educationa material.
For those with an inadequate bowel preparation risk score ≥ 3.25, negatively-framed materials emphasizing the harms of non-adherence are provided; for those with a score < 3.25, positively-framed materials emphasizing the benefits of adherence are provided.
|
Patients receive verbal instructions and printed illustrated bowel preparation educational material.
Patients with a risk score ≥ 3.25 are instructed to take low-residue diet 3 days before colonoscopy and walk for 30 minutes after each meal, with a target of approximately 6,000 steps per day.
After consuming each 500 mL of polyethylene glycol electrolyte solution, and finishing the entire solution, patients are asked to chew one piece of sugar-free gum for 10 minutes.
Patients with a score < 3.25 received the standard bowel preparation regimen.
For those with an inadequate bowel preparation risk score ≥ 3.25, negatively-framed materials emphasizing the harms of non-adherence are provided; for those with a score < 3.25, positively-framed materials emphasizing the benefits of adherence are provided.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Bowel preparation quality
Zeitfenster: Assessed by the endoscopist during colonoscopy procedure
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Bowel preparation quality is assessed using the Boston Bowel Preparation Scale (BBPS).
Bowel preparation was considered adequate when the total BBPS score was ≥ 6, with each colonic segment score ≥ 2.
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Assessed by the endoscopist during colonoscopy procedure
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of bowel preparation-related adverse events
Zeitfenster: Recorded during the waiting period prior to colonoscopy procedure
|
Incidence of nausea, vomiting, abdominal distension, abdominal pain
|
Recorded during the waiting period prior to colonoscopy procedure
|
|
Polyp/adenoma detection rate
Zeitfenster: Assessed by the endoscopist during colonoscopy procedure
|
Assessed by the endoscopist during colonoscopy procedure
|
|
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Compliance of bowel preparation
Zeitfenster: Assessed during the waiting period prior to colonoscopy procedure
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Compliance of bowel preparation is assessed by Bowel Preparation Adherence Behavior Assessment Scale.
The Bowel Preparation Adherence Behavior Assessment Scale has a total score ranging from 12 to 60, with higher scores indicating better adherence.
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Assessed during the waiting period prior to colonoscopy procedure
|
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Willingness to undergo colonoscopy again (yes/no)
Zeitfenster: Assessed during the waiting period prior to colonoscopy procedure
|
Patients are asked whether they are willing to undergo a repeat colonoscopy.
|
Assessed during the waiting period prior to colonoscopy procedure
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Studienstuhl: Xingshun Qi, The General Hospital of Northern Theater Command
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
8. Juni 2026
Primärer Abschluss (Geschätzt)
30. August 2026
Studienabschluss (Geschätzt)
30. September 2026
Studienanmeldedaten
Zuerst eingereicht
26. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. Juli 2026
Zuerst gepostet (Tatsächlich)
6. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
1. Juli 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- XHNKKY-INPI-1.0
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
The datasets analyzed during the current study are not publicly available due to ethical considerations.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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