Effect of Individualized Patient Education Including Drinking Advice Using an App

Colorectal Cancer Clinical Trial

Official title:

Effect of Individualized Patient Education Including Drinking Advice Using an App

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677050
• Other study ID #: METC 16-4-141
• Status: Completed
• Phase: N/A
• Start date: September 14, 2018
• Est. completion date: November 28, 2019

Study information

• Verified date: December 2019
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study evaluating the effect of a personalized smart phone application in addition to standard care on bowel preparation scores, compared to standard care alone.

Description:

Picoprep is a low-volume bowel preparation used to optimize visualization of the colonic mucosa during colonoscopy. Patients referred for a colonoscopy will be scheduled for an intake. During this intake patients receive education about Picoprep and will be asked about their health condition (medical history, medication use). Standard a face-to-face education is given by an intake nurse or doctor. The producers of Picoprep, Ferring BV designed an app including a drinking schedule adapted to the timing of the coloscopy, aiming a lag time between intake of the last Picoprep dose and the scopy of 2-4 hours. We hypothesize that the Boston Bowel Preparation Scale and patient satisfaction will be higher in patients receiving standard education plus using the bowel preparation app versus patients receiving single standard education.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 28, 2019
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients refered to our clinic for colonoscopy by general practitioner, colorectal cancer screening programme or outpatient clinic

• Use of regular sodium picosulfate bowel preparation scheme

• Possession of an Android or iOS smart phone

Exclusion Criteria:

• Emergency colonoscopy

• Hospitalized patients

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Smart phone patient education application
Smart phone patient education application including a personalized colonoscopy preparation scheme and information about the procedure.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel Preparation Score	Boston Bowel Preparation Score (BBPS) is a validated scale for scoring bowel preparation. Each colonic segment (ascending, transverse, descending) is scored on a scale ranging from 0 to 3, in which a higher value means a cleaner bowel segment. The total score is the sum of the three segment scores (total range 0-9).	During colonoscopy
Secondary	Patient satisfaction questionnaire	Patient satisfaction questionnaire. Several questions in our PSQ (patient satisfaction questionnaire) are based on the PSQ-18. We transformed items from the PSQ-18 to bowel preparation education purposes. The PSQ-18 yields separate scores for each of seven different subscales: General Satisfaction; Technical Quality; Interpersonal Manner; Communication; Financial Aspects; Time Spent with Doctor and Accessibility and Convenience (8, 9). Our PSQ contains items for General Satisfaction (items 3 and 6), Technical Quality (items 8 and 9), Communication (items 1 and 2), Time spent on education (item 7) and Convenience (items 4 and 5). Second, general questions are asked to determine if this was the first time patient received bowel preparation education. And last, for the app users we want to know how they rate the use of the app.	end of preparation procedure
Secondary	Caecal intubation rate	Total time from insertion of the endoscope to intubation of the caecum.	during colonoscopy
Secondary	Adenoma detection rate	percentage of patient in each group in which one or more adenoma(s) are detected.	during colonoscopy