Cathartics, Mobile Applications
Conditions
Keywords
Bowel preparation; colonoscopy; Smartphone 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.
Interventions
DEVICESmart Phone Application
Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure
DEVICEWritten instructions with visual aids
written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group).
Sponsors
Vicente Lorenzo-Zúñiga García
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Elective colonoscopy * Owners of a smartphone
Exclusion criteria
* No owners of a smartphone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 108 |
| 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). | 152 |
| Total | 260 |
Baseline characteristics
| Characteristic | Smart Phone Application (SPA) Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 48 years | 52 years | 50 years |
| Sex: Female, Male Female | 60 Participants | 100 Participants | 160 Participants |
| Sex: Female, Male Male | 48 Participants | 52 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 108 | 0 / 152 |
Outcome results
Primary
Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smart Phone Application (SPA) 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 |
| Control Group | Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure | 16.52 units on a scale | Standard Deviation 3.1 |
Secondary
Patient Satisfaction Were Assessed With a Specific Questionnaire
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smart Phone Application (SPA) 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 |
| Smart Phone Application (SPA) Group | 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 |
| Control Group | Patient Satisfaction Were Assessed With a Specific Questionnaire | Level of satisfaction (Range 0 to 10) | 6.9 units on a scale | Standard Deviation 2.7 |
| Control Group | Patient Satisfaction Were Assessed With a Specific Questionnaire | Ease of preparation for colonoscopy (Range 0 to 10 | 7.8 units on a scale | Standard Deviation 2 |