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CTRI Number  CTRI/2019/08/020732 [Registered on: 16/08/2019] Trial Registered Prospectively
Last Modified On: 27/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral
Other (Specify) [Digital Health]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial to Study the Benefit of a Mobile App to Guide Patients Preparing for Colonoscopy in Comparison to Usual Instructional Handouts. 
Scientific Title of Study   Development and Validation of a Smartphone App to Improve the Quality of Bowel Preparation for Colonoscopy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit D 
Designation  Postgraduate student (M.Sc. Health Informatics) 
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Department of Health Information Management, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9113644268  
Fax    
Email  rohitdigital@icloud.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Shiran Shetty 
Designation  [Co-Guide] Professor and Head of Department 
Affiliation  Kasturba Medical College Hospital, MAHE, Manipal 
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8861920517  
Fax    
Email  shiran.shetty@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sabu KM 
Designation  [Guide] Professor and Associate Dean 
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845421534  
Fax    
Email  sabu.km@manipal.edu  
 
Source of Monetary or Material Support
Modification(s)  
Poiesis Digital Health, TC 13/107, PRA-40, Nalumukku Junction, PETTAH, Thiruvananthapuram 695024, Kerala, India 
 
Primary Sponsor  
Name  Dr Rohit D 
Address  TC 13/107, PRA-40, Nalumukku Junction, PETTAH, Thiruvananthapuram 695024, Kerala, India 
Type of Sponsor  Other [Private Individual - Indian] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rohit D  Kasturba Medical College Hospital Manipal  Room #1, OPD Division, Department of Gastroenterology and Hepatology, 4th Floor, New OPD Building, Manipal Academy of Higher Education (MAHE)
Udupi
KARNATAKA 		 9113644268

rohitdigital@icloud.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Colonoscopy Preparation Smartphone App  Bowel prep-related patient education and engagement software. 
Comparator Agent  Printed Instructional Handout  Bowel prep-related instructions leaflet. 
 
Inclusion Criteria
Modification(s)  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Outpatient, elective, screening colonoscopy;
Age from 20 to 50 years;
Having their first colonoscopy;
Owning an Android-based smartphone with or without always-on internet connection;
Having the ability to download and configure regimen personalization settings and skillfully use the app;
Having the ability to read and understand English or Kannada or Malayalam very well;
Having and using western-style toilet bowl in their home;
Written informed consent. 
 
ExclusionCriteria 
Details  Patients with severe comorbidities (congestive heart failure, chronic renal disease, ascites, etc.);
History of prior colonoscopies (experience in bowel preparation);
Patients taking iron supplements;
History of chronic drug use (constipation drugs, laxatives, or anti-diarrheal agents);
Pregnancy or lactation;
Known inflammatory bowel disease;
Presence of psychotic or major mental illness or intellectual faculties insufficient to use a smartphone app;
Known or suspected poor compliance;
Allergy to the purgative solution;
History of colorectal surgery;
Patients with planned endoscopic therapy; 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients with Ottawa Bowel Preparation Quality Scale Score less than 8.  At the time of colonoscopy. 
 
Secondary Outcome  
Outcome  TimePoints 
Overall improvement in adherence according to a specially developed Adherence Score.  At the time of patient colonoscopy visit. 
Degree of patient satisfaction with the smartphone app for bowel preparation compared to the standard method of care.  At the time of patient colonoscopy visit. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   30/08/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Suspended 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This clinical trial is a single-center, single-blind, prospective, randomized, controlled, pilot study comparing the efficacy of a smartphone app and verbal/written patient instructions to evaluate the impact of a mobile software application in reducing the failure rate of outpatient colonoscopy by improving the quality of bowel preparation through enhanced patient adherence. The target sample size is 20 patients. The primary outcome measure will be the percentage of patients with Ottawa Bowel Preparation Quality Scale Score less than 8 during the colonoscopy procedure. The secondary outcome measures will be the overall improvement in adherence according to a specially developed Adherence Score and degree of patient satisfaction with the smartphone app for bowel preparation compared to the standard method of care. 
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