Improving Bowel Cleansing With a Smart Phone Application

• Sponsor: Vicente Lorenzo-Zúñiga García (Other)
• Overall Status: Completed
• CT.gov ID: NCT02303743
• Collaborator: (none)
• Enrollment: 260
• Arms: 2
• Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cathartics; Mobile Applications	Device: Smart Phone Application; Device: Written instructions with visual aids	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Prevention
• Official Title: Improving the Quality of Colonoscopy Bowel Preparation Using a Smart Phone Application
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Smart Phone Application; Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure
Active Comparator: Control Group Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution	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).

Outcome Measures

Primary Outcome Measures

1. Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure [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.

Secondary Outcome Measures

1. Patient Satisfaction Were Assessed With a Specific Questionnaire [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Elective colonoscopy

• Owners of a smartphone

Exclusion Criteria:

• No owners of a smartphone

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Vicente Lorenzo-Zúñiga García

Investigators

• Principal Investigator: Vicente Lorenzo-Zúñiga Garcíaa, M.D.; Ph.D., Germans Trias i Pujol Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Moviprep: ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

Publications

• Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84.
• Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003 Jul;58(1):76-9.
• Prakash SR, Verma S, McGowan J, Smith BE, Shroff A, Gibson GH, Cheng M, Lowe Ii D, Gopal K, Mohanty SR. Improving the quality of colonoscopy bowel preparation using an educational video. Can J Gastroenterol. 2013 Dec;27(12):696-700.
• Spiegel BM, Talley J, Shekelle P, Agarwal N, Snyder B, Bolus R, Kurzbard N, Chan M, Ho A, Kaneshiro M, Cordasco K, Cohen H. Development and validation of a novel patient educational booklet to enhance colonoscopy preparation. Am J Gastroenterol. 2011 May;106(5):875-83. doi: 10.1038/ajg.2011.75. Epub 2011 Apr 12.
• Tae JW, Lee JC, Hong SJ, Han JP, Lee YH, Chung JH, Yoon HG, Ko BM, Cho JY, Lee JS, Lee MS. Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy. Gastrointest Endosc. 2012 Oct;76(4):804-11. doi: 10.1016/j.gie.2012.05.026. Epub 2012 Jul 27.

• Responsible Party: Vicente Lorenzo-Zúñiga García, M.D.; Ph.D., Germans Trias i Pujol Hospital
• ClinicalTrials.gov Identifier: NCT02303743
• Other Study ID Numbers: CEI071114
• First Posted: Dec 1, 2014
• Last Update Posted: Oct 14, 2016
• Last Verified: Jan 1, 2015

• Keywords provided by Vicente Lorenzo-Zúñiga García, M.D.; Ph.D., Germans Trias i Pujol Hospital: Bowel preparation; colonoscopy; Smartphone application

Study Results

Participant Flow

Arm/Group Title	Smart Phone Application (SPA) Group	Control Group
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

Baseline Characteristics

Arm/Group Title	Smart Phone Application (SPA) Group	Control Group	Total
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 Participants	108	152	260
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	48	52	50
Sex: Female, Male (Count of Participants)
Female	60 55.6%	100 65.8%	160 61.5%
Male	48 44.4%	52 34.2%	100 38.5%

Outcome Measures

1. Primary Outcome

Title	Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Smart Phone Application (SPA) Group	Control Group
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).
Measure Participants	108	152
Mean (Standard Deviation) [units on a scale]	17.05 (3.2)	16.52 (3.1)

2. Secondary Outcome

Title	Patient Satisfaction Were Assessed With a Specific Questionnaire
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Smart Phone Application (SPA) Group	Control Group
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).
Measure Participants	108	152
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)

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Smart Phone Application (SPA) Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/108 (0%)		0/152 (0%)
Other (Not Including Serious) Adverse Events
	Smart Phone Application (SPA) Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.