NCT03677050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

September 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2019

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

1.2 years

First QC Date

September 14, 2018

Last Update Submit

December 4, 2019

Conditions

Colorectal Cancer

Keywords

Bowel preparationColonoscopySmart phone applicationPatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Patient satisfaction questionnaire

    end of preparation procedure

  • Caecal intubation rate

    during colonoscopy

  • Adenoma detection rate

    during colonoscopy

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Other: Smart phone patient education application

Interventions

Smart phone patient education applicationOTHER

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Emergency colonoscopy
  • Hospitalized patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202AZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 34420924DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsPatient Satisfaction

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • A.A.M. Masclee, Prof. MD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
colonoscopist accessing BBPS scores will be blinded; investigator will also assess BBPS scores (not blinded)
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 19, 2018

Study Start

September 14, 2018

Primary Completion

November 28, 2019

Study Completion

November 28, 2019

Last Updated

December 5, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)