Skip to main content
OpenTrials
Completed

NCT Number: NCT02410720

The Effectiveness of a Customized Mobile Application in Colonoscopy Preparation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colonoscopy Preparation Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American University of Beirut Medical Center

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Instruction leaflet

Other

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

Mobile app

Other

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

Other

The research fellow will explain instructions to patients

Picoprep solution

Other

Primary outcomes

  1. Quality of the preparation using the modified Aronshick scale

    Time frame: Directly after the Colonoscopy

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

  2. Questionnaire for adherence to the assigned diet

    Time frame: 30 minutes before the Colonoscopy

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

  3. 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

Secondary outcomes

  1. 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

  2. Questionnaire for ease of use of the mobile App

    Time frame: 30 minutes before the Colonoscopy

    Patients will be asked about the ease of use of the mobile App

  3. 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

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 8, 2015
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.