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| Name | Class |
|---|---|
| Effice Servicios Para la Investigacion S.L. | INDUSTRY |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Active Patient Rate | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Bravo | Contact | +34 915004013 | roberto.bravo@perseivivarium.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic de Barcelona | Recruiting | Barcelona | Barcelona | 08036 | Spain |
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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 | 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). | 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 | Of active patients, percentage who completed the section Procedure satisfaction questionnaire. | Day 3 (3 days after colonoscopy) |
| Patients with section completed: Adverse Events | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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 | Percentage of patients who take the laxative. | Day -3 (3 days before the colonoscopy) |
| Patient satisfaction with the bowel preparation (laxative) | 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 | 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) |