Trial Outcomes & Findings for Improving Bowel Cleansing With a Smart Phone Application (NCT NCT02303743)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

260 participants

Primary outcome timeframe

Day 1

Results posted on

2016-10-14

Participant Flow

Participant milestones

Participant milestones
Measure	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. Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure	Control Group 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 Study STARTED	108	152
Overall Study COMPLETED	108	152
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Bowel Cleansing With a Smart Phone Application

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Smart Phone Application (SPA) Group n=108 Participants 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	Control Group n=152 Participants 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 n=260 Participants Total of all reporting groups
Age, Continuous	48 years n=5 Participants	52 years n=7 Participants	50 years n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	100 Participants n=7 Participants	160 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	52 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smart Phone Application (SPA) Group n=108 Participants 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	Control Group n=152 Participants 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).
Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure	17.05 units on a scale Standard Deviation 3.2	16.52 units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Smart Phone Application (SPA) Group n=108 Participants 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	Control Group n=152 Participants 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).
Patient Satisfaction Were Assessed With a Specific Questionnaire Level of satisfaction (Range 0 to 10)	8.7 units on a scale Standard Deviation 1.6	6.9 units on a scale Standard Deviation 2.7
Patient Satisfaction Were Assessed With a Specific Questionnaire Ease of preparation for colonoscopy (Range 0 to 10	8.4 units on a scale Standard Deviation 1.7	7.8 units on a scale Standard Deviation 2.0

Adverse Events

Smart Phone Application (SPA) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vicente Lorenzo-Zúñiga García

Hospital Germans Trias i Pujol

Phone: +34-934978866

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place