- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02410720
The Effectiveness of a Customized Mobile Application in Colonoscopy Preparation
The Effectiveness of a Customized Mobile Application in Colonoscopy Preparation: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Beirut, Lebanon
- American University of Beirut Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Elective outpatient colonoscopy
- Consent to the study
- Owning a smartphone
Exclusion Criteria:
- 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
- Laxative use or dependency
- Chronic constipation (<3 spontaneous bm/week)
- Uncontrolled hypertension (systolic blood pressure ≥170 mm Hg, diastolic blood pressure ≥100 mm Hg)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Instruction leaflet
Patients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed
|
Patients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed
The research fellow will explain instructions to patients
|
Experimental: Mobile App
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
|
Patients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed
The research fellow will explain instructions to patients
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of the preparation using the modified Aronshick scale
Time Frame: Directly after the Colonoscopy
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During every colonoscopy a blinded interventionalist will assess the quality of the preparation using the modified Aronshick scale
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Directly after the Colonoscopy
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Questionnaire for adherence to the assigned diet
Time Frame: 30 minutes before the Colonoscopy
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The research coordinator will ask the patients specific questions to assess their adherence to the assigned diet ( first and second dietary changes)
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30 minutes before the Colonoscopy
|
Questionnaire for compliance with the prep protocol
Time Frame: 30 minutes before the Colonoscopy
|
The research coordinator will ask the patients specific questions to assess their compliance with the prep protocol
|
30 minutes before the Colonoscopy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction with the written instructions and mobile application using a visual analogue scale
Time Frame: 30 minutes before the Colonoscopy
|
Patient satisfaction will be assessed using a visual analogue scale
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30 minutes before the Colonoscopy
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Questionnaire for ease of use of the mobile App
Time Frame: 30 minutes before the Colonoscopy
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Patients will be asked about the ease of use of the mobile App
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30 minutes before the Colonoscopy
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Questionnaire for patient willingness to take the same preparation in the future if needed
Time Frame: 30 minutes before the Colonoscopy
|
Patients will be asked about their willingness to take the same preparation in the future if needed
|
30 minutes before the Colonoscopy
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Collaborators and Investigators
Investigators
- Principal Investigator: Ala' I Sharara, MD, American University of Beirut Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IM.AS1.35
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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