The Effectiveness of a Customized Mobile Application in Colonoscopy Preparation

Colonoscopy Preparation Clinical Trial

Official title:

The Effectiveness of a Customized Mobile Application in Colonoscopy Preparation: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410720
• Other study ID #: IM.AS1.35
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: December 28, 2015
• Start date: June 2013
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized controlled trial that will include patients undergoing elective colonoscopy at the American University of Beirut Medical Center. Patients will be randomized into one of two study arms using a computer generated randomization list. 160 patients will be enrolled in total. All patients will be instructed by the study coordinator on the importance of adherence to the protocol in the leaflet emphasizing its importance to the colonoscopy quality. In addition, patients in Arm 2 will be given information about the application features. The application will have push notifications to inform patient on time of start of dietary changes, type of diet, time of preparing the solution, time of drinking the solution, reminder of their appointment, etc. All patients will then be interviewed by the research coordinator to evaluate the adherence to the assigned diet and compliance with the prep protocol as the main outcome and the ease of the application and the patient's attitude towards having such application as secondary outcomes. Based on the results of similar studies that assessed the use of software system to improve compliance, the investigators' sample size was a calculated assuming similar results. Calculations showed that 78 patients per arm will be enough to attain significance. The number 80 was chosen as attrition is presumed to be low. As for the statistical analysis, SPSS version 20.0 will be used for data entry and analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colonoscopy Preparation

Intervention

Other:
• Instruction leaflet
Patients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed
• 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
• Explanation of paper and application instructions
The research fellow will explain instructions to patients
• Picoprep solution

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Patient satisfaction with the written instructions and mobile application using a visual analogue scale	Patient satisfaction will be assessed using a visual analogue scale	30 minutes before the Colonoscopy	No
Secondary	Questionnaire for ease of use of the mobile App	Patients will be asked about the ease of use of the mobile App	30 minutes before the Colonoscopy	No
Secondary	Questionnaire for patient willingness to take the same preparation in the future if needed	Patients will be asked about their willingness to take the same preparation in the future if needed	30 minutes before the Colonoscopy	No