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

NCT06916052 | Recruiting

• 1 other identifier: COLObs
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Outpatient Colonoscopy

Keywords

Colonoscopy preparation; Digital Platform; Caaring; Outpatient colonoscopy; DTx; Patient-reported Data; Real World Data; RWD; PROMs; Digital Health

Outcome Measures

Primary Outcomes (1)

• Percentage of patients scheduled colonoscopy who have an adequate bowel preparation.

  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 Outcomes (16)

• Active Patient Rate

  Day -14 (14 days before the colonoscopy)

• Patients with section completed: Treatments

  Day -14 (14 days before the colonoscopy)

• Patients with section completed: Pick up the bowel preparation

  Day -10 (10 days before colonoscopy)

• Patients with section completed: Colonoscopy Preparation Solution (laxative).

  Day 2 (2 days after colonoscopy)

• Patients with section completed: Procedure satisfaction questionnaire

  Day 3 (3 days after colonoscopy)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Persei Vivarium: lead
• Effice Servicios Para la Investigacion S.L.: collaborator

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

Central Study Contacts

Roberto Bravo

CONTACT

+34 915004013; roberto.bravo@perseivivarium.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: March 13, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)