NCT05801250

Brief Summary

Educational interventions provided to patients may improve colon cleansing. The aims of this study were to develop an AI platform which can help patients evaluate the adequacy of bowel cleansing without the aid of caregivers and to investigate whether there was a statistically positive correlation between the Image rating and the BBPS score.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
249

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

April 2, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2023

Completed
Last Updated

April 6, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 24, 2023

Last Update Submit

March 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • BBPS

    The Boston Bowel Preparation Scale (BBPS) is a rating scale used to evaluate the adequacy of bowel preparation.

    3 months

Secondary Outcomes (1)

  • ADR

    3 months

Study Arms (2)

AI platform

EXPERIMENTAL

All the patients in these group were asked to scan a QR code using smartphone to follow the WeChat public account.The WeChat public account can automatically push clear written instructions for bowel preparation. Including dietary advice ,how to consume the laxatives and remind patients to upload pictures.Patients will receive a reminder to upload stool images from the WeChat public account. After uploading their images, the patients received an evaluation result of "pass" or "not pass" . For patients who received results of "not pass," the system displayed tips instructing the patients to drink more water, or walk to improve the bowel preparation quality.

Behavioral: AI Platform

Manual guidance

NO INTERVENTION

A leaflet with clear written instructions on how to consume the laxatives was given to patients in these group.

Interventions

AI PlatformBEHAVIORAL

AI platform can help patients evaluate the adequacy of bowel cleansing without the aid of caregivers.

AI platform

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People sign an "informed consent form"
  • People able to use smartphone to follow the WeChat public account

You may not qualify if:

  • People who have contraindications for colonoscopy
  • People who have known colorectal polyps
  • People with history of surgery in any part of the large bowel
  • People who refuse to join the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Li yanqing, Professor

    Qilu Hospital of Shandong University

    STUDY CHAIR

Central Study Contacts

Song yihao, BD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 24, 2023

First Posted

April 6, 2023

Study Start

April 2, 2023

Primary Completion

June 2, 2023

Study Completion

June 10, 2023

Last Updated

April 6, 2023

Record last verified: 2023-03