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Improving Bowel Cleansing With a Smart Phone Application

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ClinicalTrials.gov Identifier: NCT02303743
Recruitment Status : Completed
First Posted : December 1, 2014
Results First Posted : January 13, 2015
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Vicente Lorenzo-Zúñiga García, Germans Trias i Pujol Hospital

Tracking Information
First Submitted Date  ICMJE November 24, 2014
First Posted Date  ICMJE December 1, 2014
Results First Submitted Date  ICMJE December 2, 2014
Results First Posted Date  ICMJE January 13, 2015
Last Update Posted Date October 14, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2015)
Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure [ Time Frame: Day 1 ]
The quality of bowel cleansing is evaluated after colonoscopy (Day 1). Baseline the patients initiated low fiber diet in the 24 hours prior to colonoscopy. The HCS uses a 5-point qualitative scale in 5 separate colon segments. HCS is the sum of 5 segments, ranging from 0 (worst possible outcome) to 20 (best possible outcome). Global score assesses the quality of bowel cleansing: Successful (A or B) / unsuccessful (C or D). A: All segments scored 3 or 4; B: One or more segments scored 2; C: One or more segments scored 1; and D: One or more segments scored 0.
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure [ Time Frame: Day 1 ]
The quality of bowel cleansing is evaluated after colonoscopy (Day 1). Baseline the patients initiated low fiber diet in the 24 hours prior to colonoscopy. The HCS uses a 5-point qualitative scale in 5 separate colon segments. Global score assesses the quality of bowel cleansing: Successful (A or B) / unsuccessful (C or D).
Change History Complete list of historical versions of study NCT02303743 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2015)
Patient Satisfaction Were Assessed With a Specific Questionnaire [ Time Frame: Day 1 ]
Patient satisfaction were assessed with a specific questionnaire before colonoscopy. Patients were asked if they used the application and their satisfaction with the app. Again, the endoscopist was blinded to the answers. The items read as follows: (1) "Do you have experience with a previous colonoscopy?"; (2) "Have you used the phone application?"; (3) "How easy was the preparation for colonoscopy?"; (4) "Which is your level of satisfaction with the bowel preparation?"; (5) "Would you like to repeat the same preparation in the future?"; (6) "Did you have any difficulty with the preparation?". Patient responses to the questionnaire were categorical (yes or no; questions 1, 2, 5, and 6) or numerical scale answers (0 to 10), from very difficult or very bad (0 or close to 0) to very easy or very good (10 or close to 10) (items 3 and 4).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
Patient Satisfaction Were Assessed With a Specific Questionnaire [ Time Frame: Day 1 ]
Patient satisfaction were assessed with a specific questionnaire before colonoscopy. Patients were asked if they used the application and their satisfaction with the app. Again, the endoscopist was blinded to the answers. The items read as follows: (1) "Do you have experience with a previous colonoscopy?"; (2) "Have you used the phone application?"; (3) "How easy was the preparation for colonoscopy?"; (4) "Which is your level of satisfaction with the bowel preparation?"; (5) "Would you like to repeat the same preparation in the future?"; (6) "Did you have any difficulty with the preparation?". Patient responses to the questionnaire were categorical (yes or no; questions 1, 2, 5, and 6) or numerical scale answers (0 to 10), from very difficult or very bad to very easy or very good (items 3 and 4).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Bowel Cleansing With a Smart Phone Application
Official Title  ICMJE Improving the Quality of Colonoscopy Bowel Preparation Using a Smart Phone Application
Brief Summary Getting ready for a colonoscopy is difficult and involves a lot of steps. The information given to patients is very important to adherence to treatment. The investigators have created a novel smart phone application (SPA) aimed to increased bowel preparation quality and patient satisfaction, using different educational tools.
Detailed Description

Background: Getting ready for a colonoscopy is difficult and involves a lot of steps. The information given to patients is very important to adherence to treatment. The investigators have created a novel smart phone application (SPA) aimed to increased bowel preparation quality and patient satisfaction, using different educational tools.

Methods: The investigators have performed a prospective, endoscopist-blinded, randomized, controlled trial. The investigators have enrolled 260 outpatients owners of a smartphone. Patients were randomly allocated to two different protocols: instructions provided by SPA (SPA group; n=108) or written instructions with visual aids (control group; n=152). All procedures were performed in afternoon time and patients received the same purgative regimen (2-L PEG solution plus ascorbic acid), in a full-dose same-day regimen. The day before colonoscopy (Baseline), patients initiated low fiber diet. The study was designed to detect an improvement in quality of bowel preparation using the Harefield Cleansing Scale (HCS) scale. The effect of protocol on patient satisfaction was assessed with a specific questionnaire at time of the colonoscopy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Cathartics
  • Mobile Applications
Intervention  ICMJE
  • Device: Smart Phone Application
    Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure
  • Device: Written instructions with visual aids
    written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group).
Study Arms  ICMJE
  • Active Comparator: Smart Phone Application (SPA) Group
    Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.
    Intervention: Device: Smart Phone Application
  • Active Comparator: Control Group
    Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution
    Intervention: Device: Written instructions with visual aids
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2014)
260
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Elective colonoscopy
  • Owners of a smartphone

Exclusion Criteria:

  • No owners of a smartphone
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02303743
Other Study ID Numbers  ICMJE CEI071114
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vicente Lorenzo-Zúñiga García, Germans Trias i Pujol Hospital
Study Sponsor  ICMJE Vicente Lorenzo-Zúñiga García
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vicente Lorenzo-Zúñiga Garcíaa, M.D.; Ph.D. Germans Trias i Pujol Hospital
PRS Account Germans Trias i Pujol Hospital
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP