Effect of Individualized Patient Education Including Drinking Advice Using an App

NCT ID: NCT03677050

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-14
• Study Completion Date: 2019-11-28

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Control

patients receiving standard care (verbal and written instructions) before colonoscopy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Patients instructed to use a smart phone patient education app in addition standard care

Group Type: EXPERIMENTAL

Smart phone patient education application

Intervention Type: OTHER

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

Interventions

Smart phone patient education application

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

A.A.M. Masclee, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

van der Zander QEW, Reumkens A, van de Valk B, Winkens B, Masclee AAM, de Ridder RJJ. Effects of a Personalized Smartphone App on Bowel Preparation Quality: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Aug 19;9(8):e26703. doi: 10.2196/26703.

Reference Type: DERIVED

PMID: 34420924 (View on PubMed)

Other Identifiers

METC 16-4-141

Identifier Type: -

Identifier Source: org_study_id