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Short Message Service in Colonoscopy Preparation (PERICLES-II-SMS) (PERICLES-II)

Primary Purpose

Colon Cancer

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Colonoscopy
mobile phone
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Cancer focused on measuring Colonoscopy, Colonoscopy preparation, screening, New media, SMS, Short message service

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • no outpatient colonoscopy
  • no mobile phone

Sites / Locations

  • Dr. Aschenbeck
  • Gastroenterologische Praxis Prof. Leopold Ludwig
  • II. Medizinische Klinik Krankenhaus Landshut-Achdorf
  • 2nd Medical Department, Klinikum rechts der Isar

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SMS receiving

Non-SMS receiving

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adenoma detection rate
Histopathological analysis of polyps resected towards adenoma rate
Patient satisfaction and compliance
Patient´s satification with the colonoscopy preparation either SMS supported or not ist asked by a questionnaire

Full Information

First Posted
October 20, 2014
Last Updated
April 19, 2017
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT02272036
Brief Title
Short Message Service in Colonoscopy Preparation (PERICLES-II-SMS)
Acronym
PERICLES-II
Official Title
Improvement of Colonoscopy Preparation by New Media (SMS) (PERICLES-II-Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to analyze if integration of new media (SMS) could improve the quality of colonoscopy preparation.
Detailed Description
The study approach is the implementation of new media into colonoscopy preparation. As most of our patients already use mobile phones the study should evaluate if time adjusted information about diet recommendation, laxative intake and behavioral recommedation improve the patient compliance and the quality of colonoscopy preparation. In total 14 SMS wil be sent to the study participants starting 4 days prior the colonoscopy appointment. No additional or different information is provided in comparison to regular colonoscopy preparation for out-patient colonoscopy. Study participant are randomized when included into the study. Group 1 receives a SMS- supported colonoscopy preparation, group 2 receive no SMS and prepares regularly. Primary endpoint is bowel cleanness measured by Boston Bowel preparation scale, secondary endpoints are patient satisfaction, adenoma detection rate and compliance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Colonoscopy, Colonoscopy preparation, screening, New media, SMS, Short message service

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMS receiving
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-SMS receiving
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Intervention Description
Colonoscopy is performed in both study arm as standard examination
Intervention Type
Device
Intervention Name(s)
mobile phone
Intervention Description
SMS received by mobile phone
Primary Outcome Measure Information:
Title
Bowel cleanness measured by Boston Bowel preparation Scale
Description
Boston bowel preparation scale (BBPS) is measured by the endoscopist during colonoscopy
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Adenoma detection rate
Description
Histopathological analysis of polyps resected towards adenoma rate
Time Frame
1 day
Title
Patient satisfaction and compliance
Description
Patient´s satification with the colonoscopy preparation either SMS supported or not ist asked by a questionnaire
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: over 18 years old written informed consent mobile phone user appointment for outpatient colonoscopy Exclusion Criteria: no outpatient colonoscopy no mobile phone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin M Walter, MD
Organizational Affiliation
Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Aschenbeck
City
Berlin
Country
Germany
Facility Name
Gastroenterologische Praxis Prof. Leopold Ludwig
City
Dornstadt
Country
Germany
Facility Name
II. Medizinische Klinik Krankenhaus Landshut-Achdorf
City
Landshut
Country
Germany
Facility Name
2nd Medical Department, Klinikum rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30138612
Citation
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.
Results Reference
derived

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Short Message Service in Colonoscopy Preparation (PERICLES-II-SMS)

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