Colonoscopy PreparationNCT02410720
The Effectiveness of a Customized Mobile Application in Colonoscopy Preparation
A study testing Instruction leaflet, Mobile App and Explanation of paper and application instructions in people with Colonoscopy Preparation, run by American University of Beirut Medical Center at 1 site in Lebanon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy Preparation
- What is being tested?
- Instruction leaflet, Mobile App and Explanation of paper and application instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteLebanon
- Study dates
- Jun 2013to Jul 2015
- 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
- Elective outpatient colonoscopy
- Consent to the study
- Owning a smartphone
Who cannot join
- Pregnant or lactating women
- Age less than 18 years
- Known Inflammatory bowel disease
- Significant gastroparesis
- Gastric outlet obstruction
- Ileus
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed 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.
- Conditions
- Colonoscopy Preparation
- Being tested
- Instruction leaflet, Mobile App, Explanation of paper and application instructions, Picoprep solution
- Keywords
- Colonoscopy Preparation, Polyethylene Glycols, Mobile application, Software, Compliance, Patient Compliance, Adherence
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instruction leafletOther
Patients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed
Mobile AppOther
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 instructionsOther
The research fellow will explain instructions to patients
Picoprep solutionOther
| Study group | Role | What they receive |
|---|---|---|
| Instruction leaflet | Active comparator | Patients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed Receives: Other: Instruction leaflet; Other: Explanation of paper and application instructions; Other: Picoprep solution |
| Mobile App | Experimental | 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 Receives: Other: Instruction leaflet; Other: Mobile App; Other: Explanation of paper and application instructions; Other: Picoprep solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Directly after the Colonoscopy
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)
Measured: 30 minutes before the Colonoscopy
Questionnaire for compliance with the prep protocol
The research coordinator will ask the patients specific questions to assess their compliance with the prep protocol
Measured: 30 minutes before the Colonoscopy
Secondary outcomes (3)
Patient satisfaction with the written instructions and mobile application using a visual analogue scale
Patient satisfaction will be assessed using a visual analogue scale
Measured: 30 minutes before the Colonoscopy
Questionnaire for ease of use of the mobile App
Patients will be asked about the ease of use of the mobile App
Measured: 30 minutes before the Colonoscopy
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
Measured: 30 minutes before the Colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startJun 2013
- Primary completionMar 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonoscopy PreparationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ala'a Sharara, American University of Beirut Medical Center
- Investigators
- Ala' I Sharara, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410720
- Sponsor's protocol ID
- IM.AS1.35
- Status last verified
- Dec 2015
- First submitted
- 10 Jul 2013
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sharara AI, Chalhoub JM, Beydoun M, Shayto RH, Chehab H, Harb AH, Mourad FH, Sarkis FS. A Customized Mobile Application in Colonoscopy Preparation: A Randomized Controlled Trial. Clin Transl Gastroenterol. 2017 Jan 5;8(1):e211. doi: 10.1038/ctg.2016.65.
PubMed 28055031
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Customized Mobile Application in Colonoscopy Preparation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02410720
- Acronym / sponsor ID
- IM.AS1.35
- Conditions
- Colonoscopy Preparation
- Keywords
- Colonoscopy Preparation, Polyethylene Glycols, Mobile application, Software, Compliance, Patient Compliance, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Apr 2015 (estimated)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instruction leaflet | Active comparator | Other: Instruction leaflet, Other: Explanation of paper and application instructions, Other: Picoprep solutionPatients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed |
| Mobile App | Experimental | Other: Instruction leaflet, Other: Mobile App, Other: Explanation of paper and application instructions, Other: Picoprep solutionPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective outpatient colonoscopy
- Consent to the study
- Owning a smartphone
Key exclusion criteria (18 listed)
- Pregnant or lactating women
- Age less than 18 years
- Known Inflammatory bowel disease
- Significant gastroparesis
- Gastric outlet obstruction
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 |
|---|---|---|
| Instruction leafletPatients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed | Other | Instruction leaflet, Mobile App |
| Mobile AppPatients 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 | Other | Mobile App |
| Explanation of paper and application instructionsThe research fellow will explain instructions to patients | Other | Instruction leaflet, Mobile App |
| Picoprep solution | Other | Instruction leaflet, Mobile App |
Primary outcome
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
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)
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
3 secondary outcomes
Patient satisfaction with the written instructions and mobile application using a visual analogue scale
Time frame: 30 minutes before the Colonoscopy
Questionnaire for ease of use of the mobile App
Time frame: 30 minutes before the Colonoscopy
Questionnaire for patient willingness to take the same preparation in the future if needed
Time frame: 30 minutes before the 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 29 Dec 2015.
- Derived from this study: PubMed 28055031Sharara AI, Chalhoub JM, Beydoun M, Shayto RH, Chehab H, Harb AH, Mourad FH, Sarkis FS. A Customized Mobile Application in Colonoscopy Preparation: A Randomized Controlled Trial. Clin Transl Gastroenterol. 2017 Jan 5;8(1):e211. doi: 10.1038/ctg.2016.65.
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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.
Ala' I Sharara, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instruction leaflet, Mobile App and Explanation of paper and application instructions in people with Colonoscopy Preparation, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 3 inclusion and 18 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 29 Dec 2015. 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 Lebanon. 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 the preparation using the modified Aronshick scale (time frame: Directly after the Colonoscopy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02410720, which also lists 1 linked publication.
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 29 Dec 2015.