Colorectal Cancer ScreeningCOLOPREPNCT03225560
Smart Phone App for COLOnoscopic PREParation
A study testing Bowel Preparation in people with Colorectal Cancer Screening and Colonoscopy, run by Sunil Patel at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Screening, Colonoscopy, Mass Screening
- What is being tested?
- Bowel Preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteCanada
- Study dates
- 21 Nov 2018to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Access to smart phone with the ability to download smart phone application
- Outpatient screening colonoscopy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Smart Phone Application for Patients Undergoing COLOnoscopic Bowel PREParation: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Colorectal Cancer Screening, Colonoscopy, Mass Screening
- Being tested
- Bowel Preparation
- Keywords
- Smart Phone Application, Bowel Preparation, Colorectal Cancer Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel PreparationOther
Bowel Preparation is completed prior to colonoscopy to ensure adequate visualization of the bowel lumen. This requires diet modifications and taking of medications at specified time intervals.
| Study group | Role | What they receive |
|---|---|---|
| Smart Phone Application | Experimental | A novel smart phone application available for both Apple iOS and Google Android platforms with capabilities to populate the phone calendar with automated reminders/notifications at the appropriate times prior to the colonoscopy. Receives: Other: Bowel Preparation |
| Traditional Paper Instructions | Active comparator | Traditional paper instructions for bowel preparation Receives: Other: Bowel Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Bowel Preparation
The quality of bowel preparation as assessed by the validated Boston and Aronchick bowel preparation scales
Measured: At time of colonoscopy
Secondary outcomes (3)
Cecal Intubation
The ability for the colonoscopist to intubate the cecum
Measured: At time of colonoscopy
Adenomatous polyp detection
The number of adenomatous polyps detected
Measured: At time of colonoscopy
Patient reported adherence to bowel preparation instructions
Patient questionnaire used to determine the adherence to the pre-specified bowel preparation instructions.
Measured: At time of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start21 Nov 2018
- Primary completion31 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunil Patel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sunil Patel, Queen's University
- Investigators
- Sunil V Patel, MD MSc, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225560
- Sponsor's protocol ID
- 6020364
- Acronym
- COLOPREP
- Status last verified
- Nov 2023
- First submitted
- 19 Jul 2017
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Smart Phone Application for Patients Undergoing COLOnoscopic Bowel PREParation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03225560
- Acronym / sponsor ID
- COLOPREP / 6020364
- Conditions
- Colorectal Cancer Screening, Colonoscopy, Mass Screening
- Keywords
- Smart Phone Application, Bowel Preparation, Colorectal Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Sunil PatelUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Smart Phone Application | Experimental | Other: Bowel PreparationA novel smart phone application available for both Apple iOS and Google Android platforms with capabilities to populate the phone calendar with automated reminders/notifications at the appropriate times prior to the colonoscopy. |
| Traditional Paper Instructions | Active comparator | Other: Bowel PreparationTraditional paper instructions for bowel preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Access to smart phone with the ability to download smart phone application
- Outpatient screening colonoscopy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bowel PreparationBowel Preparation is completed prior to colonoscopy to ensure adequate visualization of the bowel lumen. This requires diet modifications and taking of medications at specified time intervals. | Other | Smart Phone Application, Traditional Paper Instructions |
Primary outcome
Quality of Bowel Preparation
Time frame: At time of colonoscopy
The quality of bowel preparation as assessed by the validated Boston and Aronchick bowel preparation scales
3 secondary outcomes
Cecal Intubation
Time frame: At time of colonoscopy
Adenomatous polyp detection
Time frame: At time of colonoscopy
Patient reported adherence to bowel preparation instructions
Time frame: At time of colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil V Patel, MD MSc principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bowel Preparation in people with Colorectal Cancer Screening and Colonoscopy, run by Sunil Patel at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Bowel Preparation (time frame: At time of colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.