Clinical trial NCT03225560: Smart Phone App for COLOnoscopic PREParation
Official title: A Novel Smart Phone Application for Patients Undergoing COLOnoscopic Bowel PREParation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Colonoscopy
Mass Screening
Keywords: Smart Phone Application
Bowel Preparation
Colorectal Cancer Screening
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial designed to assess the efficacy of a novel smartphone application as an automated reminder tool in improving the quality of bowel preparation for patients undergoing outpatient colonoscopies. The investigators will be comparing the smartphone application to traditional instructions for bowel preparation. The quality of bowel preparation will be assessed using the Ottawa and Aronchick bowel preparation scales.

Detailed description: This is a randomized controlled trial designed to assess the efficacy of a novel smartphone application as an automated reminder tool in improving the quality of bowel preparation for patients undergoing outpatient colonoscopies at an academic teaching hospital in Kingston, Ontario.

The intervention under investigation is the use of a novel smart phone application which serves as an automated reminder system for patients undergoing outpatient colonoscopies. The application requires the patients to enter the date and time of the colonoscopy appointment and automatically populates the patients' phones with calendar reminders as well as pre-recorded messages regarding cessation of solid food intake, the need for clear fluid intake, as well as timing of their bowel regimens starting 7 days prior.

The design of this study is a prospective, randomized controlled trial with single blinding (endoscopist). Eligible participants will be randomized into either the control (routine paper instructions) or the intervention group (smart phone application). Those who are randomized into the intervention group will be provided with specific instructions to download and setup the smart phone application at least 7 days prior to their scheduled appointment. Upon arrival to their appointment, participants in both groups will be asked to complete a survey confirming the adherence to either paper instructions or instructions provided by the smart phone application.

The primary outcome of this study is the adequacy of the bowel preparation, as assessed by using the Ottawa and Aronchick bowel preparation scales, which have been previously validated and are in common usage for colonoscopy procedures. Secondary outcomes include rate of polyp detection, rate of cecal intubation, and patient reported ease of use and adherence to the bowel regimen instructions.

Eligibility criteria: Inclusion Criteria:

* Access to smart phone with the ability to download smart phone application
* Outpatient screening colonoscopy

Exclusion Criteria:

* Patient refusal
* Bowel preparation other than pico-salax or GoLytely
* Urgent/Emergent Colonoscopy
* Patient requiring combined upper and lower endoscopic evaluation
* No access to smart phone or inability to download smart phone application
* Surveillance colonoscopy for previously resected cancer
* Inflammatory bowel disease

Primary outcomes:
measure: Quality of Bowel Preparation
timeFrame: At time of colonoscopy
Secondary outcomes:
measure: Cecal Intubation
timeFrame: At time of colonoscopy
measure: Adenomatous polyp detection
timeFrame: At time of colonoscopy
measure: Patient reported adherence to bowel preparation instructions
timeFrame: At time of colonoscopy
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Queen's University
name: Sunil V Patel, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: