NCT02410720

Brief Summary

Colonoscopy is the preferred procedure to investigate any large-bowel disease in adults and children. In addition, colonoscopy is the current gold standard for colorectal cancer screening due to its high diagnostic capabilities and its unique feature that permits sampling and removal of pathology. For optimal performance and visualization of details, however, an adequate bowel preparation is essential. Inadequate bowel preparation is associated with cancelled procedures, prolonged procedure time, incomplete examination, increased cost and possibly complications, physician frustration and patient anxiety, but most importantly serving to impede colorectal cancer screening and surveillance. A good bowel preparation would need a solution with a reasonable volume, acceptable taste, minimal diet restrictions, and easy to follow instructions; and would also need patients' adherence to the instructions and diet restrictions. Noncompliance of patients to the diet restrictions, the starting day of diet, the timing of drinking the solution, and other instructions play an important role in rendering the colon preparation inadequate. Aim: The investigators aim, at assessing the influence of having a reminder mobile application on the compliance and adherence to instructions and diet and consequently on the quality of colon preparation. Hypothesis: The investigators' hypothesis is that patients having a customized mobile App reminding them systematically about instruction and time of intake of the preparation will have a better adherence to the prep protocol and likely on the quality preparation than those given written and verbal instructions in clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

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

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

July 10, 2013

Last Update Submit

December 28, 2015

Conditions

Colonoscopy Preparation

Keywords

Colonoscopy PreparationPolyethylene GlycolsMobile applicationSoftwareCompliancePatient ComplianceAdherence

Outcome Measures

Primary Outcomes (3)

  • Quality of the preparation using the modified Aronshick scale

    During every colonoscopy a blinded interventionalist will assess the quality of the preparation using the modified Aronshick scale

    Directly after the Colonoscopy

  • Questionnaire for adherence to the assigned diet

    The research coordinator will ask the patients specific questions to assess their adherence to the assigned diet ( first and second dietary changes)

    30 minutes before the Colonoscopy

  • Questionnaire for compliance with the prep protocol

    The research coordinator will ask the patients specific questions to assess their compliance with the prep protocol

    30 minutes before the Colonoscopy

Secondary Outcomes (3)

  • Patient satisfaction with the written instructions and mobile application using a visual analogue scale

    30 minutes before the Colonoscopy

  • Questionnaire for ease of use of the mobile App

    30 minutes before the Colonoscopy

  • Questionnaire for patient willingness to take the same preparation in the future if needed

    30 minutes before the Colonoscopy

Study Arms (2)

Instruction leaflet

ACTIVE COMPARATOR

Patients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed

Other: Instruction leafletOther: Explanation of paper and application instructionsOther: Picoprep solution

Mobile App

EXPERIMENTAL

Patients will receive Picoprep solution with an instruction leaflet + Picoprep Mobile App which will be downloaded to their smartphones that has the same information plus a reminder utility

Other: Instruction leafletOther: Mobile AppOther: Explanation of paper and application instructionsOther: Picoprep solution

Interventions

Instruction leafletOTHER

Patients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed

Instruction leafletMobile App
Mobile AppOTHER

Patients will receive Picoprep solution with an instruction leaflet + Picoprep Mobile App which will be downloaded to their smartphones that has the same information plus a reminder utility

Mobile App
Explanation of paper and application instructionsOTHER

The research fellow will explain instructions to patients

Instruction leafletMobile App
Picoprep solutionOTHER
Instruction leafletMobile App

Eligibility Criteria

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

You may qualify if:

  • Elective outpatient colonoscopy
  • Consent to the study
  • Owning a smartphone

You may not qualify if:

  • Pregnant or lactating women
  • Age less than 18 years
  • Known Inflammatory bowel disease
  • Significant gastroparesis
  • Gastric outlet obstruction
  • Ileus
  • Known or suspected bowel obstruction or perforation
  • Phenylketonuria
  • Toxic colitis or megacolon
  • Having a stoma
  • Compromised swallowing reflex or mental status
  • Psychiatric disease or known or suspected poor compliance
  • Severe chronic renal failure (creatinine clearance \<30 mL/minute)
  • Severe congestive heart failure (New York Heart Association \[NYHA\] class III or IV)
  • Dehydration
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

Related Publications (1)

  • Sharara AI, Chalhoub JM, Beydoun M, Shayto RH, Chehab H, Harb AH, Mourad FH, Sarkis FS. A Customized Mobile Application in Colonoscopy Preparation: A Randomized Controlled Trial. Clin Transl Gastroenterol. 2017 Jan 5;8(1):e211. doi: 10.1038/ctg.2016.65.

    PMID: 28055031DERIVED

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ala' I Sharara, MD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 10, 2013

First Posted

April 8, 2015

Study Start

June 1, 2013

Primary Completion

March 1, 2015

Study Completion

July 1, 2015

Last Updated

December 29, 2015

Record last verified: 2015-12

Locations

LE(1)