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

June 13, 2025 updated by: Persei Vivarium

An Observational Study of the Digital Platform Use for the Preparation and Monitoring of Patients With Scheduled Outpatient Colonoscopy

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients from the Hospital Clínic in Barcelona diagnosed with a scheduled colonoscopy who meet the selection criteria and sign the informed consent will be included.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients scheduled colonoscopy who have an adequate bowel preparation.
Time Frame: 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.
Day 0, (Colonoscopy Day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active Patient Rate
Time Frame: 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.
Day -14 (14 days before the colonoscopy)
Patients with section completed: Treatments
Time Frame: Day -14 (14 days before the colonoscopy)
Of active patients, percentage who completes the section Treatments
Day -14 (14 days before the colonoscopy)
Patients with section completed: Pick up the bowel preparation
Time Frame: Day -10 (10 days before colonoscopy)
Of active patients, percentage who completes the section Pick up the bowel preparation.
Day -10 (10 days before colonoscopy)
Patients with section completed: Colonoscopy Preparation Solution (laxative).
Time Frame: Day 2 (2 days after colonoscopy)
Of active patients, percentage who completes the secion Colonoscopy Preparation Solution (laxative).
Day 2 (2 days after colonoscopy)
Patients with section completed: Procedure satisfaction questionnaire
Time Frame: Day 3 (3 days after colonoscopy)
Of active patients, percentage who completed the section Procedure satisfaction questionnaire.
Day 3 (3 days after colonoscopy)
Patients with section completed: Adverse Events
Time Frame: Day 1, Day 14 and Day 30
Of active patients, percentage of patients who completes the Adverse Events section.
Day 1, Day 14 and Day 30
Percentage of patients with 100% of data completed
Time Frame: Day 31 (31days after the colonoscopy)
Percentage of patients with 100% of data completed in the application.
Day 31 (31days after the colonoscopy)
Patients who view educational materials: Pick up the laxative
Time Frame: 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.
Day -10 (10 days before colonoscopy)
Patients who view educational materials: Diet
Time Frame: 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.
Day -4 (4 days before colonoscopy)
Patients who view educational materials: Adequate preparation for a colonoscopy
Time Frame: 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.
Day -4 (4 days before colonoscopy)
Patients who view educational materials: Bring someone
Time Frame: 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.
Day -4 (4 days before colonoscopy)
Patients who view educational materials: Instructions for your colonoscopy
Time Frame: 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.
Day -3 (3 days before colonoscopy)
Percentage of patients with 100% of education materials viewed.
Time Frame: Day 31 (31days after the colonoscopy)
Percentage of patients with 100% of educational materials viewed in the application.
Day 31 (31days after the colonoscopy)
Percentage of patients who take the laxative
Time Frame: Day -3 (3 days before the colonoscopy)
Percentage of patients who take the laxative.
Day -3 (3 days before the colonoscopy)
Patient satisfaction with the bowel preparation (laxative)
Time Frame: 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.
Day 2 (2 days after colonoscopy)
Patient satisfaction with the colonoscopy experience
Time Frame: 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.
Day 3 (3 days after colonoscopy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Persei Vivarium

Collaborators

Effice Servicios Para la Investigacion S.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • COLObs

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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