A Mobile Application to Improve the Quality of Colonoscopy in Colorectal Cancer Screening Program (PrepColon APP)

NCT06314022 | Recruiting DMC

• 1 other identifier: 22-PI113
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 2

Brief Summary

Colonoscopy is the gold standard for the diagnosis and resection of preneoplastic lesions, allowing the prevention of colon cancer. A colonoscopy is more efficient with proper preparation of the colon, as it allows for a higher rate of adenoma detection and cecal intubation. In routine practice, up to 30% of colonoscopies are poorly prepared and 11% of patients do not show up for their appointment. Adenomas not visualized in the initial colonoscopy due to poor preparation reached 68% and the rate of undetected cancers was 66.7%. A proper colon cleanse is conditioned by different factors; among them, failure to comply with the diet and take laxatives poses 5 times the risk of having a deficient colon preparation. The purpose of our study is the design and implementation of an app that facilitates the preparation of colonoscopy and evaluates its impact on compliance with diet and laxative intake.

Conditions

Premalignant Colon Lesions; Colorectal Cancer

Keywords

quality colonoscopy; colorrectal cancer screening; mobile application

Outcome Measures

Primary Outcomes (4)

• Compliance with the diet and intake of laxatives with the use of a mobile application

  Questionnaire about ASSESSMENT OF DIET COMPLIANCE (number of portions 0-\>2, higher points means worse outcome): Have you followed the diet without fiber the 3 days prior to preparation: YES/ NO * Have you eaten fruits, vegetables and legumes? number of portions 0 1 2 \>2 * Have you eaten whole grain products? number of portions 0 1 2 \>2 * Have you eaten meats and sausages? number of portions 0 1 2 \>2 * Have you eaten blue fish? number of portions 0 1 2 \>2 * Have you eaten nuts? number of portions 0 1 2 \>2 * Have you eaten anything solid in the last 24 hours? yes/ no

  at the moment of the procedure

• Evaluate the quality of colon cleansing with mobile application as an experimental factor

  The endoscopy will assess colon cleansing according to the Boston Bowel Scale (BBPS) uses a 4-point rating system (0-3) applied to each of the 3 segments of the colon (right, transverse, left) to assess colon cleanliness during the withdrawal phase of colonoscopy, after all cleaning maneuvers have been performed. (0 worse outcome and 3 best outcome)

  at the moment of the procedure

• Assessment of the usability of the APP

  A questionare: System Usability scale (SUS), ten question about usability with Five responses ranging from Strongly Agree to Strongly Disagree

  at the moment of the procedure

• Compliance with the laxative intake with the use of the mobile application

  Questionnaire to EVALUATE COMPLIANCE WITH TAKING THE LAXATIVE: questions like at • --Type of laxative: (name): * Colonoscopy appointment (time) Morning / Afternoon * Start of taking the laxative: time: * End of taking the laxative (How many hours ago did you finish taking the laxative before the appointment? * Have you taken all of the laxative? * How much liquid have you drunk? * How many shots have you done it in? How much liquid does each drink?

  At the moment of the procedure

Secondary Outcomes (4)

• Assessment of the difficulty of the preparation instructions

  at the moment of the procedure

• Evaluate colonoscopy quality indicators:

  at the moment of the procedure and after one month with the histological results

• Evaluate attendance at the scheduled colonoscopy appointment

  at the moment of the colonoscopy

• Evaluate colonoscopy quality indicators

  at the moment of the colonoscopy

Study Arms (2)

Control group

NO INTERVENTION

which receives the standard information given in writing,

APP group

ACTIVE COMPARATOR

Group which receives the standard information together with the mobile application individually adapted to the scheduled colonoscopy appointment and the type of laxative.

Other: Mobile application for colonoscopy preparation instructions

Interventions

Mobile application for colonoscopy preparation instructions OTHER

The APP will also consider the comorbidities and drugs of each patient. It can be adapted to the different types of laxative (4, 2 or 1 litre) and notify the need to discontinue anticoagulant and/or antiplatelet treatments by contacting with the primary care physician. Additionally, the application may ask short questions to the patient to control the laxative intake instruction. The user must confirm the appointment 48 hours in advance.

APP group

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects between 50-69 years old from the CRC screening program with FIT (\>100ng/ml).
• Informed consent granted in writing

You may not qualify if:

• Refusal to give informed consent.
• Those who do not have a smartphone with a minimum version of the operating system (Android 4.4 or iOS 14, which cover more than 99% of the terminals in use)
• Symptomatic patients
• Subjects at elevated risk of CRC due to family history or inherited polyposis diseases or inflammatory bowel disease

Sponsors & Collaborators

• Hospital del Rio Hortega: lead

Study Sites (2)

Hospital Universitario Rio Hortega

Valladolid, Valladolid, 47012, Spain

RECRUITING

Hospital Universitario Rio Hortega

Valladolid, Valladolid, 47012, Spain

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Henar Nuñez Rodriguez, MDPhD

  Hospital Universitario Rio Hortega

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henar Nuñez Rodriguez, MDPhD

CONTACT

34 983 420400; henarnrod@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patients who agree to participate in the study are randomized by a 1:1 block computer program (an attempt will be made to balance the groups according to the type of laxative) into two groups: group A: control group, which receives the standard information given in writing, and group B: APP group, which receives the standard information together with the mobile application individually adapted to the scheduled colonoscopy appointment and the type of laxative. Patients scheduled for a screening colonoscopy will be contacted by telephone, those who agree to participate will be scheduled with the nurse, after giving their consent they are randomized. Group B will indicate how to download the APP and its management. The endoscopist performing the examination is blind for randomization and will assess colon cleansing according to the Boston Bowel Scale (Lai EJ. et al Gastroinest Endosc 2009).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each subject will be randomized into two groups according to the instructions given to perform the preparation of the colon prior to colonoscopy: group A: perform the preparation with the written instructions delivered in the consultation and group B: they will be given the instructions in writing and will also be indicated how to install the APP.

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 15, 2024
• Study Start: May 2, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)