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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Care Provider);   Primary Purpose: Prevention
Conditions Cathartics
Mobile Applications
Interventions Device: Smart Phone Application
Device: Written instructions with visual aids
Enrollment 260
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Smart Phone Application (SPA) Group Control Group
Hide Arm/Group Description

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.

Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure

Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution

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).

Period Title: Overall Study
Started 108 152
Completed 108 152
Not Completed 0 0
Arm/Group Title Smart Phone Application (SPA) Group Control Group Total
Hide Arm/Group Description

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.

Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure

Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution

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).

Total of all reporting groups
Overall Number of Baseline Participants 108 152 260
Hide Baseline Analysis Population Description
Men and women aged 18 and older with scheduled elective colonoscopy. All enrolled outpatients were able to follow instructions and owners of a smartphone
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 108 participants 152 participants 260 participants
48
(30 to 66)
52
(21 to 85)
50
(21 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 152 participants 260 participants
Female
60
  55.6%
100
  65.8%
160
  61.5%
Male
48
  44.4%
52
  34.2%
100
  38.5%
1.Primary Outcome
Title Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Smart Phone Application (SPA) Group Control Group
Hide Arm/Group Description:

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.

Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure

Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution

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).

Overall Number of Participants Analyzed 108 152
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.05  (3.2) 16.52  (3.1)
2.Secondary Outcome
Title Patient Satisfaction Were Assessed With a Specific Questionnaire
Hide Description 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).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Smart Phone Application (SPA) Group Control Group
Hide Arm/Group Description:

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.

Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure

Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution

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).

Overall Number of Participants Analyzed 108 152
Mean (Standard Deviation)
Unit of Measure: units on a scale
Level of satisfaction (Range 0 to 10) 8.7  (1.6) 6.9  (2.7)
Ease of preparation for colonoscopy (Range 0 to 10 8.4  (1.7) 7.8  (2.0)
Time Frame 6 months (from January to June 2014).
Adverse Event Reporting Description Other (Not Including Serious) Adverse Events were not collected for any participants
 
Arm/Group Title Smart Phone Application (SPA) Group Control Group
Hide Arm/Group Description

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.

Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure

Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution

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).

All-Cause Mortality
Smart Phone Application (SPA) Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Smart Phone Application (SPA) Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/152 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Smart Phone Application (SPA) Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Vicente Lorenzo-Zúñiga García
Organization: Hospital Germans Trias i Pujol
Phone: +34-934978866 ext 8443
Responsible Party: Vicente Lorenzo-Zúñiga García, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT02303743     History of Changes
Other Study ID Numbers: CEI071114
First Submitted: November 24, 2014
First Posted: December 1, 2014
Results First Submitted: December 2, 2014
Results First Posted: January 13, 2015
Last Update Posted: October 14, 2016