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Completed

NCT Number: NCT03677050

Effect of Individualized Patient Education Including Drinking Advice Using an App

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

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Key information

Conditions

Colorectal Cancer Behavior Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Health Behavior Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Patient Satisfaction Rectal Diseases Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6202AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smart phone patient education application

Other

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

Primary outcomes

  1. Boston Bowel Preparation Score

    Time frame: 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 outcomes

  1. Patient satisfaction questionnaire

    Time frame: 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.

  2. Caecal intubation rate

    Time frame: during colonoscopy

    Total time from insertion of the endoscope to intubation of the caecum.

  3. Adenoma detection rate

    Time frame: during colonoscopy

    percentage of patient in each group in which one or more adenoma(s) are detected.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2018
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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