Effect of Individualized Patient Education Including Drinking Advice Using an App

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Individualized Patient Education Including Drinking Advice Using an App

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Smart phone patient education application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>patients receiving standard care (verbal and written instructions) before colonoscopy | |
| Experimental: Intervention<br>Patients instructed to use a smart phone patient education app in addition standard care | Other: Smart phone patient education application<br>* Smart phone patient education application including a personalized colonoscopy preparation scheme and information about the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Caecal intubation rate | Total time from insertion of the endoscope to intubation of the caecum. | during colonoscopy | 
| Adenoma detection rate | percentage of patient in each group in which one or more adenoma(s) are detected. | during colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient satisfaction, Bowel preparation, Colonoscopy, Smart phone application