NCT02272036

Brief Summary

The purpose of this study is to analyze if integration of new media (SMS) could improve the quality of colonoscopy preparation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

4 active sites

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

October 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

October 20, 2014

Last Update Submit

April 19, 2017

Conditions

Colon Cancer

Keywords

ColonoscopyColonoscopy preparationscreeningNew mediaSMSShort message service

Outcome Measures

Primary Outcomes (1)

  • Bowel cleanness measured by Boston Bowel preparation Scale

    Boston bowel preparation scale (BBPS) is measured by the endoscopist during colonoscopy

    1 day

Secondary Outcomes (2)

  • Adenoma detection rate

    1 day

  • Patient satisfaction and compliance

    1 day

Study Arms (2)

SMS receiving

ACTIVE COMPARATOR

Study participants of the SMS group receive in total 14 short messages (SMS) containing time adjusted information on colonoscopy preparation starting 4 days before colonoscopy appointment on their mobile phones.

Procedure: ColonoscopyDevice: mobile phone

Non-SMS receiving

ACTIVE COMPARATOR

Study participants of the Non-SMS-Group do not receive any SMS before colonoscopy. Preparation is done according to regular written information given to the patient.

Procedure: Colonoscopy

Interventions

ColonoscopyPROCEDURE

Colonoscopy is performed in both study arm as standard examination

Non-SMS receivingSMS receiving
mobile phoneDEVICE

SMS received by mobile phone

SMS receiving

Eligibility Criteria

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

You may qualify if:

  • over 18 years old
  • written informed consent
  • mobile phone user
  • appointment for outpatient colonoscopy

You may not qualify if:

  • no outpatient colonoscopy
  • no mobile phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dr. Aschenbeck

Berlin, Germany

Location

Gastroenterologische Praxis Prof. Leopold Ludwig

Dornstadt, Germany

Location

II. Medizinische Klinik Krankenhaus Landshut-Achdorf

Landshut, Germany

Location

2nd Medical Department, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Related Publications (1)

  • Walter B, Klare P, Strehle K, Aschenbeck J, Ludwig L, Dikopoulos N, Mayr M, Neu B, Hann A, Mayer B, Meining A, von Delius S. Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II). Gastrointest Endosc. 2019 Mar;89(3):506-513.e4. doi: 10.1016/j.gie.2018.08.014. Epub 2018 Aug 21.

    PMID: 30138612DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Benjamin M Walter, MD

    Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 22, 2014

Study Start

December 1, 2015

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations

DE(4)