Effect of Individualized Patient Education Including Drinking Advice Using an App

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Smart phone patient education application

• Registration Number: NCT03677050
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-09-14
• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-19
• Primary Completion: 2019-11-28
• Study Completion: 2019-11-28
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Smart phone patient education application	Patients instructed to use a smart phone patient education app in addition standard care

Primary Outcome Measures

Name	Time	Method
Boston Bowel Preparation Score	During colonoscopy	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).

Secondary Outcome Measures

Name	Time	Method
Adenoma detection rate	during colonoscopy	percentage of patient in each group in which one or more adenoma(s) are detected.
Caecal intubation rate	during colonoscopy	Total time from insertion of the endoscope to intubation of the caecum.
Patient satisfaction questionnaire	end of preparation procedure	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.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands