Study to Analyse the Use of a Digital Platform for the Preparation and Follow-up of Patients With Scheduled Outpatients Colonoscopy

Recruiting

• Conditions: Outpatient Colonoscopy

• Registration Number: NCT06916052
• Lead Sponsor: Persei Vivarium

Brief Summary

The goal of this clinical trial investigation with device is to to analyze the use of the Caaring® digital platform for the preparation and follow-up of scheduled colonoscopy.

Colonoscopy is a difficult procedure, and it is estimated that bowel preparation is inadequate in about 25% of patients. The main question it aims to answer is if the use of a digital platform (Caaring®) could be an effective tool for reducing the percentage of inadequate bowel preparations in patients with a scheduled colonoscopy. To this end, the application will provide precise instructions to patients.

A prospective, single-center, observational study with software device: The recruitment phase is expected to last two months. Patients will be followed for one month after the colonoscopy and 14 days prior to it.

Additionally, measuring patient experience and monitoring adverse effects after a colonoscopy are crucial to improving the safety of colonoscopies and the quality of healthcare, promoting higher quality colonoscopy services.

For that to happen, participants must have sufficient technological skills to use a smartphone.

Detailed Description

A prospective, single-center, observational study with software device. The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki.

Study Timeline

• Study Start: 2025-03-13
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Study First Posted: 2025-04-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-15
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• Age 18 or older.
• Signed informed consent.
• Patients scheduled for outpatient colonoscopy.
• Patients able to complete the study questionnaires.
• Patients who regularly use a smartphone

Exclusion Criteria

• Patients enrolled in the population-based colorectal cancer screening program with a positive fecal occult blood test.
• Minors or elderly patients (over 80 years of age).
• Patients with prior colorectal surgery.
• Patients who, in the opinion of the researcher, will not be able to commit to follow-up or lack adequate technological skills.
• Inability to provide adequate informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients scheduled colonoscopy who have an adequate bowel preparation.	Day 0, (Colonoscopy Day)	Percentage of colonoscopies with adequate bowel preparation defined as having a total Boston Bowel Preparation Scale (BBPS) score greater than or equal of 6 and BBPS score for per colon segment ≥2.

Secondary Outcome Measures

Name	Time	Method
Active Patient Rate	Day -14 (14 days before the colonoscopy)	Active patient rate defined as the number of patients who activate their account divided by the total number of patients guests.
Patients with section completed: Treatments	Day -14 (14 days before the colonoscopy)	Of active patients, percentage who completes the section Treatments
Patients with section completed: Pick up the bowel preparation	Day -10 (10 days before colonoscopy)	Of active patients, percentage who completes the section Pick up the bowel preparation.
Patients with section completed: Colonoscopy Preparation Solution (laxative).	Day 2 (2 days after colonoscopy)	Of active patients, percentage who completes the secion Colonoscopy Preparation Solution (laxative).
Patients with section completed: Procedure satisfaction questionnaire	Day 3 (3 days after colonoscopy)	Of active patients, percentage who completed the section Procedure satisfaction questionnaire.
Patients with section completed: Adverse Events	Day 1, Day 14 and Day 30	Of active patients, percentage of patients who completes the Adverse Events section.
Percentage of patients with 100% of data completed	Day 31 (31days after the colonoscopy)	Percentage of patients with 100% of data completed in the application.
Patients who view educational materials: Pick up the laxative	Day -10 (10 days before colonoscopy)	Of active patients, percentage of Patients who view the educational materials: Pick up the laxative. The app will reflect the date and time that patients viewed that information.
Patients who view educational materials: Diet	Day -4 (4 days before colonoscopy)	Of active patients, percentage of Patients who view the educational material: Diet. The app will reflect the date and time that patients viewed that information.
Patient satisfaction with the bowel preparation (laxative)	Day 2 (2 days after colonoscopy)	The patient satisfaction with the bowel preparation will be measured through a specific satisfaction questionnaire created for this purpose. (Value 1-4). A higher score reflects greater satisfaction with software care.
Patients who view educational materials: Adequate preparation for a colonoscopy	Day -4 (4 days before colonoscopy)	Of active patients, percentage of Patients who view the educational material: Adequate preparation for a colonoscopy . The app will reflect the date and time that patients viewed that information.
Patients who view educational materials: Bring someone	Day -4 (4 days before colonoscopy)	Of active patients, percentage of Patients who view the educational material: bring someone. The app will reflect the date and time that patients viewed that information.
Patients who view educational materials: Instructions for your colonoscopy	Day -3 (3 days before colonoscopy)	Of active patients, percentage of Patients who view the educational material: Instructions for your colonoscopy. The app will reflect the date and time that patients viewed that information.
Percentage of patients with 100% of education materials viewed.	Day 31 (31days after the colonoscopy)	Percentage of patients with 100% of educational materials viewed in the application.
Percentage of patients who take the laxative	Day -3 (3 days before the colonoscopy)	Percentage of patients who take the laxative.
Patient satisfaction with the colonoscopy experience	Day 3 (3 days after colonoscopy)	The patient satisfaction with the colonoscopy experience will be measured through a specific satisfaction questionnaire created for this purpose. (Value 1-5). A higher score reflects greater satisfaction with software care.

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain