Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04898426




Registration number
NCT04898426
Ethics application status
Date submitted
11/05/2021
Date registered
24/05/2021
Date last updated
16/08/2021

Titles & IDs
Public title
Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy.
Scientific title
Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy: a Randomised Controlled Trial.
Secondary ID [1] 0 0
GriffithBH
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon Polyp 0 0
Colon Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Enhanced bowel preparation instruction

No Intervention: Standard Bowel Preparation Instruction - Patients receive the standard-of-care bowel preparation instruction.

Experimental: Enhanced Bowel Preparation Instruction - Patients receive enhanced instructions (SMS, phone call, info website) in addition to the standard-of-care bowel preparation instruction.


Other interventions: Enhanced bowel preparation instruction
Automated delivery of SMS, pre-recorded phone call, and link to an information website.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bowel preparation quality
Timepoint [1] 0 0
Bowel preparation quality is scored once for each patient at the time of colonoscopy completion. We expect to conduct this score in 500 patients over the study period of approximately 12 months.
Secondary outcome [1] 0 0
Colonoscopy cancellation rate
Timepoint [1] 0 0
Colonoscopy cancellation rate will be calculated at the time of study completion, expected to be 12 months.
Secondary outcome [2] 0 0
Caecal intubation rate
Timepoint [2] 0 0
Caecal intubation rate will be calculated at the time of study completion, expected to be 12 months.
Secondary outcome [3] 0 0
Polyp detection rate
Timepoint [3] 0 0
Polyp detection rate will be calculated at the time of study completion, expected to be 12 months.

Eligibility
Key inclusion criteria
- Elective colonoscopy booking at Griffith Base Hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Emergency colonoscopy

- Patients who are unable to understand bowel preparation instructions in the following
languages: English, Italian, Punjabi, Gujarati, Samoan, Mandarin.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2022
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Griffith Base Hospital - Griffith
Recruitment postcode(s) [1] 0 0
2680 - Griffith

Funding & Sponsors
Primary sponsor type
Other
Name
Griffith Base Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Efficacy Evaluation of Enhanced Bowel Preparation Instructions in Elective Colonoscopy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04898426
Trial related presentations / publications
Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
Chokshi RV, Hovis CE, Hollander T, Early DS, Wang JS. Prevalence of missed adenomas in patients with inadequate bowel preparation on screening colonoscopy. Gastrointest Endosc. 2012 Jun;75(6):1197-203. doi: 10.1016/j.gie.2012.01.005. Epub 2012 Feb 28.
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. doi: 10.1016/s0016-5107(04)02776-2.
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. doi: 10.1067/mge.2003.294.
Guo X, Yang Z, Zhao L, Leung F, Luo H, Kang X, Li X, Jia H, Yang S, Tao Q, Pan Y, Guo X. Enhanced instructions improve the quality of bowel preparation for colonoscopy: a meta-analysis of randomized controlled trials. Gastrointest Endosc. 2017 Jan;85(1):90-97.e6. doi: 10.1016/j.gie.2016.05.012. Epub 2016 May 14.
Kang X, Zhao L, Leung F, Luo H, Wang L, Wu J, Guo X, Wang X, Zhang L, Hui N, Tao Q, Jia H, Liu Z, Chen Z, Liu J, Wu K, Fan D, Pan Y, Guo X. Delivery of Instructions via Mobile Social Media App Increases Quality of Bowel Preparation. Clin Gastroenterol Hepatol. 2016 Mar;14(3):429-435.e3. doi: 10.1016/j.cgh.2015.09.038. Epub 2015 Oct 20.
Liu X, Luo H, Zhang L, Leung FW, Liu Z, Wang X, Huang R, Hui N, Wu K, Fan D, Pan Y, Guo X. Telephone-based re-education on the day before colonoscopy improves the quality of bowel preparation and the polyp detection rate: a prospective, colonoscopist-blinded, randomised, controlled study. Gut. 2014 Jan;63(1):125-30. doi: 10.1136/gutjnl-2012-304292. Epub 2013 Mar 16.
Lee YJ, Kim ES, Choi JH, Lee KI, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Impact of reinforced education by telephone and short message service on the quality of bowel preparation: a randomized controlled study. Endoscopy. 2015 Nov;47(11):1018-27. doi: 10.1055/s-0034-1392406. Epub 2015 Jul 16.
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.
Calderwood AH, Lai EJ, Fix OK, Jacobson BC. An endoscopist-blinded, randomized, controlled trial of a simple visual aid to improve bowel preparation for screening colonoscopy. Gastrointest Endosc. 2011 Feb;73(2):307-14. doi: 10.1016/j.gie.2010.10.013. Epub 2010 Dec 18.
Janahiraman S, Tay CY, Lee JM, Lim WL, Khiew CH, Ishak I, Onn ZY, Ibrahim MR, Chew CK. Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial. BMJ Open Gastroenterol. 2020 May;7(1):e000376. doi: 10.1136/bmjgast-2020-000376.
Walter B, Frank R, Ludwig L, Dikopoulos N, Mayr M, Neu B, Mayer B, Hann A, Meier B, Caca K, Seufferlein T, Meining A. Smartphone Application to Reinforce Education Increases High-Quality Preparation for Colorectal Cancer Screening Colonoscopies in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Feb;19(2):331-338.e5. doi: 10.1016/j.cgh.2020.03.051. Epub 2020 Mar 30. Erratum In: Clin Gastroenterol Hepatol. 2022 Jan;20(1):250.
Public notes

Contacts
Principal investigator
Name 0 0
Minh Pham
Address 0 0
Researcher
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Minh Pham
Address 0 0
Country 0 0
Phone 0 0
+61 2 6969 5555
Fax 0 0
Email 0 0
minhpham@medgneer.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04898426