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

Design of a Mobile Application to Improve the Quality of Colonoscopy and Its Implementation in Colorectal Cancer Screening Program: a Randomized Multicenter Study (PrepColon APP Study)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Premalignant Colon Lesions
• Intervention / Treatment: Other: Mobile application for colonoscopy preparation instructions

Detailed Description

STUDY DESIGN AND METHODS

Study Design:

Phase 1: Design of the mobile application (APP): The APP will be designed in a participatory manner by the research team of the project, formed by doctors, nurses, statisticians and telecommunications engineers. The application should be usable with both Android and iOS devices, so we will use the Flutter framework to build apps for different platforms with a single code base.

When arranging a colonoscopy, the patient will install the APP on their mobile phone and indicate the date and time of the test. The APP will be responsible for supporting the preparation of the colon cleansing, for which, in addition to being able to visualize the corresponding information, it will make use of notifications to show diet reminders and laxative intakes.

More specifically, these could be some notifications:

• (3 days before the appointment) - Notification of start of preparation with a low fibre diet
• (24 hours before the appointment) - Notification of .laxative intake..

The APP will also consider the comorbidities and drugs of each participant. 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 control the laxative intake instruction. The user must confirm the appointment 48 hours in advance. The design of the APP aims to be intuitive and easy to use by the target population (50-69 years), allowing to adapt the font size and zoom in on the images to facilitate the visualization of the information.

The APP will be multilingual for English and Spanish, and others may be incorporated if deemed necessary. An agile and iterative methodology of software development will be followed as SCRUM in the realization of the APP. Thus, sprints of about 3 weeks will be planned with delivery of functional software that will progressively incorporate the different functionalities planned for the APP.

Phase 2: Re-evaluation of the APP after the inclusion of 30 patients, the APP will be re-evaluated through a usability questionnaire and adjustments and changes will be made if necessary

Phase 3: Prospective, multicentre and randomized study in asymptomatic patients between 50 and 69 years who attend screening colonoscopy after a positive FIT >100 ng / ml)

The study will be carried out in the Digestive Service of 3 hospitals in Castilla y León: Virgen de la Concha Hospital in Zamora, Medina del Campo Hospital and Río Hortega University Hospital in Valladolid. Participants 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: the investigators will give the instructions in writing and will also indicate how to install the APP to the participants.

• Study Type: Interventional
• Enrollment (Estimated): 470
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henar Nuñez Rodriguez, MDPhD; Phone Number: 34 983 420400; Email: henarnrod@yahoo.es

Study Locations

• Spain
  • Valladolid, Spain, 47012
    • Hospital Universitario Río Hortega

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; which receives the standard information given in writing,
Experimental: APP group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the difficulty of the preparation instructions	quesionnaire: EVALUATION OF THE COMPRESSION OF THE INSTRUCTIONS GIVEN: scale from 0 to 10 (0:worse outcomes and 10: best outcomes)	at the moment of the procedure
Evaluate colonoscopy quality indicators:	Adenoma detection rate (ADR) is the percentage of patients with at least one histologically proven adenoma or carcinoma	at the moment of the procedure and after one month with the histological results
Evaluate attendance at the scheduled colonoscopy appointment	Attendance or not to colonoscopy appointment	at the moment of the colonoscopy
Evaluate colonoscopy quality indicators	Cecal intubation rate is the percentage of patients with completed colonoscopy	at the moment of the colonoscopy

Collaborators and Investigators

• Sponsor: Hospital del Río Hortega
• Investigators: Principal Investigator: Henar Nuñez Rodriguez, MDPhD, Hospital Universitario Río Hortega

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 10, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: mobile application; quality colonoscopy; colorrectal cancer screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Precancerous Conditions
• Other Study ID Numbers: 22-PI113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No