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

Colorectal Cancer Clinical Trial

— PREPCOLON  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06314022
• Other study ID #: 22-PI113
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: Hospital del Río Hortega
• Contact: Henar Nuñez Rodriguez, MDPhD
• Phone: 34 983 420400
• Email: henarnrod[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 470
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Precancerous Conditions

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Rio Hortega	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Río Hortega

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Evaluate attendance at the scheduled colonoscopy appointment	Attendance or not to colonoscopy appointment	at the moment of the colonoscopy
Secondary	Evaluate colonoscopy quality indicators	Cecal intubation rate is the percentage of patients with completed colonoscopy	at the moment of the colonoscopy