Clinical trial NCT06569277: Impact of a Colonoscopy Preparation Mobile App on Colonoscopic Cleanliness and Experience
Official title: Effects of a Smartphone Mobile Application on Quality of Bowel Preparation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Preparation
Patient Experience
Patient Satisfaction
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The most crucial factor determining the success and quality of a colonoscopy procedure is the patient's adherence to proper bowel preparation. When a colonoscopy is scheduled, patients are provided with a diet plan designed to improve the quality of bowel cleansing, in addition to bowel-cleansing medications, through the endoscopy secretariat. Typically, in cases of inadequate bowel cleansing, where the bowel wall is not sufficiently visible during the colonoscopy, it is found that patients have poor adherence to the diet plan and have consumed incorrect or insufficient foods. This inadequate bowel cleansing can lead to missed pathologies such as polyps, colitis, diverticulosis, angiodysplasia, and cancer, which may cause patient complaints or symptoms.

Currently, patients who come to our secretariat from various clinics and polyclinics for colonoscopy appointments receive a single-page informational sheet containing a 5-day pre-procedure diet plan. In our study, the investigators aim to increase patient adherence to the colonoscopy diet by providing a comprehensive mobile application that includes recommendations and recipes for the foods listed in the colonoscopy preparation diet plan. This randomized study will involve selecting suitable patients who have accepted our study from routine colonoscopy requests and analyzing the impact of this mobile application on the quality of colon cleansing, the time to reach the cecum, and the detection rate of colon polyps.

The quality of bowel cleansing will be assessed using the Boston Bowel Preparation Score, where a score of 6 or higher for the entire colon and scores above 2 for each individual segment indicate adequate cleaning. The time to reach the cecum will be tracked using a stopwatch on our mobile phone during the colonoscopy, and the rate of colon polyp detection will be retrospectively reviewed after the study concludes.

The goal of this study is to enhance patient adherence through a free mobile application and to reduce unnecessary administrative costs.

Detailed description: A total of 104 patients were included in this study. At the time of scheduling an outpatient colonoscopy, intervention group and control group were randomly assigned using a random-number generator for treatment allocation. The research protocol was explained during the colonoscopy appointment, and patients, when the participants agreed to follow their preparation to the mobile application, were accepted as part of the patient intervention group. A consent form was signed and collected. The nurse responsible for patient education in the endoscopy secretariat informed the patient that this mobile application is an important component of bowel preparation and adhere strictly to the recipes and recommendations. The group who received the standard diet list and applied for their colonoscopy appointments were randomly designated as the control group. Bowel preparation was evaluated during the colonoscopy using the Boston Bowel Preparation Scale (BBPS). Cecal insertion and withdrawal times, polyp detection rate, utilization of the recipe resource, and patients' experiences related to colonoscopy were recorded.

The research team utilized freely available resources from general cookery recipe websites to create the recipes, adapting it to align with the recommendations for a low-residue diet . Recipes were selected based on criteria such as being visually appealing, easy to prepare, and easily modifiable to comply with the low-residue diet. A dietitian examined the recipes to guarantee that the recipes followed low-residue diet guidelines. The colon preparation recommendations have been obtained from free medical information websites on the internet to facilitate adherence to bowel cleansing.

Eligibility criteria: Inclusion Criteria:

- All outpatients who apply for a colonoscopy appointment.

Exclusion Criteria:

* Patients with a history of prior colonoscopic procedures
* Using anticholinergic or gastrointestinal motility-reducing drugs
* Severe chronic kidney failure (GFR\<30 ml/min)
* Advanced heart failure (NYHA III-IV)
* History of abdominal surgery were not included in the study.

Primary outcomes:
measure: Boston Bowel Preparation Scale (BBPS)
timeFrame: immediately after the procedure
Secondary outcomes:
measure: cecal insertion time(minutes)
timeFrame: during the procedure
measure: withdrawal time (minutes)
timeFrame: during the procedure
measure: polyp detection rate
timeFrame: during the procedure
measure: patient experience
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Oncology and Training Research Hospital
Study officials:
affiliation: clinical physician
name: selim demirci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao K, Dong R, Xia S, Feng L, Zhou W, Zhang M, Zhang Y, Tian D, Liu M, Liao J. Improving the quality of bowel preparation by smartphone education platform prior to colonoscopy: a randomized trail. Ann Med. 2022 Dec;54(1):2777-2784. doi: 10.1080/07853890.2022.2130972.
citation: Dao HV, Dao QV, Lam HN, Hoang LB, Nguyen VT, Nguyen TT, Vu DQ, Pokorny CS, Nguyen HL, Allison J, Goldberg RJ, Dao ATM, Do TTT, Dao LV. Effectiveness of using a patient education mobile application to improve the quality of bowel preparation: a randomised controlled trial. BMJ Open Gastroenterol. 2023 Jun;10(1):e001107. doi: 10.1136/bmjgast-2023-001107.
citation: van der Zander QEW, Reumkens A, van de Valk B, Winkens B, Masclee AAM, de Ridder RJJ. Effects of a Personalized Smartphone App on Bowel Preparation Quality: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Aug 19;9(8):e26703. doi: 10.2196/26703.