ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000747729

Ethics application status

Approved

Date submitted

17/05/2022

Date registered

25/05/2022

Date last updated

23/02/2024

Date data sharing statement initially provided

25/05/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Digitising colonoscopy care pathways and enhancing bowel preparation quality with patient reported measures (DIGICLEAN).

Scientific title

A multicentre, colonoscopist-blinded, randomised controlled trial to determine the efficacy of dynamic multimedia bowel preparation instructions versus standard instructions as control on adenoma detection and patient reported measures in adults aged 45 years and older indicated for a colonoscopy.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1278-2201

Trial acronym

DIGICLEAN (DIGItising CoLonoscopy care pathways to Enhance bowel preparation And polyp detectioN)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

colorectal cancer

Condition category

Condition code

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants in the interventional arm of the study will receive their bowel preparation instructions delivered via scheduled SMS, web-based smartphone application, email, and videos. All enrolled participants must possess a smartphone device. The interventional arm will occur in parallel design with the control arm. Depending on whether participants have a history of constipation, bloating, or diverticular disease as assessed by the faecal occult blood test (FOBT) nurse or the gastroenterologist at the initial phone call, participants will be stratified into one of two groups depending on their indicated bowel preparation regimens.

Participants will be either given Standard Bowel Preparation instructions with PLENVU [macrogol 3350, sodium ascorbate, sodium sulfate anhydrous, ascorbic acid, sodium chloride, potassium chloride; polyethylene glycol containing ascorbic acid (PEG-ASC)], or Enhanced Bowel Preparation [PLENVU plus daily Movicol (sodium chloride, potassium chloride, bicarbonate, macrogol 3350) and Senokot (sennoside)]. Additional aperients, such as Movicol and Senokot, will be encouraged in the interventional arm through dynamic multimedia instructions if indicated. Participants will be asked to take PLENVU over a two-day split dosing schedule with the first 500 mL dose of PLENVU (including additional 500 mL of clear fluid) taken in the evening before the clinical procedure (at 6 pm) and the second 500 mL dose (including additional 500 mL of clear fluid) in the early morning of the day of the clinical procedure (at 5 am for morning procedure or 8 am for afternoon procedures). Participants in the Enhanced Bowel Preparation group will also take 1 sachet of Movicol and 2 Senokot tablets daily at 0800 in the week leading up to the colonoscopy.

In the week leading up to the colonoscopy, depending on the bowel preparation group, regular SMS will be sent to the participant one to three times daily to remind participants regarding appropriate dietary and bowel preparation instructions (at 0800, 1700 and 2000). Scheduled SMS and messaging will also occur on the day prior to colonoscopy occurring at indicated times to consume bowel preparation. Daily assessment of dietary adherence and constipation, which involves completing a survey lasting for two to five minutes, will occur via the web-based smartphone application and depending on patient reported responses, dietary advice or alterations in bowel preparation will be given. The message delivery system will be monitored via a web interface by the FOBT nurse or the study nurse. A video explaining the procedure and the bowel preparation course will be sent to the participant via SMS and email at the time of enrolment and at 7 days before the colonoscopy, which can be re-accessed through a hyperlink. Participants will be asked to self-report their stool consistency and stool colour via the smartphone app after completion of their bowel preparation before the colonoscopy, and if unsatisfactory, may be advised to request a Fleet enema (sodium biphosphate and sodium phosphate) at time of arrival to the hospital. A Fleet enema is a laxative given via the rectum which causes bowel movements in around give minutes.

After the colonoscopy, patient reported measures will be assessed. Additionally, depending on the site of the study, some participants will undergo their pre-anaesthetic assessment using the web-based application which will occur once at the time of enrolment.

Intervention code [1]

Early detection / Screening

Intervention code [2]

Diagnosis / Prognosis

Comparator / control treatment

Participants in the control arm of the study will receive their bowel preparation instructions delivered via routine standard means, such as written, verbal, emailed or posted instructions. Depending on whether participants have a history of constipation, bloating, or diverticular disease as assessed by the FOBT nurse or the gastroenterologist at the initial phone call, participants will be stratified into one of two groups depending on their indicated bowel preparation regimens. Participants will be either given instructions for Standard Bowel Preparation with PLENVU [macrogol 3350, sodium ascorbate, sodium sulfate anhydrous, ascorbic acid, sodium chloride, potassium chloride; polyethylene glycol containing ascorbic acid (PEG-ASC)], or Enhanced Bowel Preparation [PLENVU plus regular Movicol (sodium chloride, potassium chloride, bicarbonate, macrogol 3350) and Senokot (sennosides)]. Additional aperients may be encouraged in the control arm but this will be presented as paper-based/written instructions. The bowel preparation regimens are the same as the interventional groups. Participants in the control arm will be given the same instructions in paper-based/emailed form (including instructions for additional aperients), but not through dynamic multimedia messaging and participants will not be routinely assessed for constipation leading up to their procedure. Participants will be advised via written means to request a Fleet enema (sodium biphosphate and sodium phosphate) at time of arrival to the hospital if their stool consistency or stool colour is unsatisfactory. A Fleet enema is a laxative given via the rectum which causes bowel movements in around give minutes. After the colonoscopy, patient reported measures and self-reported adherence will be assessed. Adherence to diet, constipation, and bowel preparation routine will not be assessed prior to colonoscopy via digital means.

Control group

Active

Outcomes

Primary outcome [1]

Comparison of the adenoma detection rate based on histopathology assessment of biopsy samples collected at the time of colonoscopy in patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive verbal and/or written bowel preparation instructions.

Timepoint [1]

At the time of colonoscopy assessment.

Primary outcome [2]

Compare the patient reported measures using the validated colonoscopy-specific Newcastle ENDOPREM Questionnaire on the day after colonoscopy between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions.

Timepoint [2]

One day after colonoscopy assessment.

Secondary outcome [1]

Compare the Boston Bowel Preparation Score at the time of colonoscopy in patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive verbal and/or written bowel preparation instructions.

Timepoint [1]

At the time of colonoscopy assessment.

Secondary outcome [2]

Compare the caecal intubation success rate at the time of colonoscopy on review of the procedural report between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions.

Timepoint [2]

At the time of colonoscopy assessment.

Secondary outcome [3]

Compare the mean procedural time duration measured in minutes from the time of colonoscope insertion through to removal from the anal canal on review of the procedural report between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions.

Timepoint [3]

At the time of colonoscopy assessment.

Secondary outcome [4]

Compare the cancellation and non-presentation rate related to patient factors on review of medical records between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions.

Timepoint [4]

At the time of colonoscopy assessment.

Eligibility

Key inclusion criteria

1. Indicated for colonoscopy as an outpatient with a positive faecal occult blood test, rectal bleeding, or iron deficiency anaemia
2. Aged 45 years and above
3. Have a smartphone device which can support web browsing and use the web-based application
4. Be able to independently give informed consent by verbal means
5. Possess a working email address for the purposes of consenting and information sharing

Minimum age

45 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Non-English-speaking backgrounds
2. Inpatient at any hospital
3. Scheduled colonoscopy date changed or delayed due to provider factors affecting the normal care sequence
4. Colonoscopy within the last 5 years.
5. Previous bowel resection or stoma
6. Glucose-6-phosphate dehydrogenase deficiency (due to the presence of ascorbic acid in PEG-ASC)
7. New York Heart Association heart failure classes III or IV
8. Chronic kidney disease stages 4 and 5 (eGFR < 30 mL/min/1.73m2)
9. Not indicated or contraindicated for a colonoscopy
10. Contraindication to standard bowel preparation regimens
11. Hypersensitivity to any ingredient in PLENVU
12. Cognitive disorder which would normally preclude from independent standard bowel preparation
13. Inflammatory bowel disease
14. Known polyp or diagnosis of colorectal cancer

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sequentially numbered, opaque, sealed envelope

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation. Participants will be stratified by their indicated bowel preparation regimen: PLENVU only or Enhanced Bowel Preparation in patients with a history of constipation, diverticular disease, or bloating.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Power calculations were based on a previous randomised controlled trial by Walter, Frank et al., which compared the quality of bowel preparation and adenoma detection rates with 2 L polyethylene glycol (PEG) plus ascorbic acid, in patients who received a smartphone application versus patients who received written materials that had the same contents.

This study is of independent cases and controls with 1 control per case. Prior data from Walter, Frank et al. indicate that the adenoma detection rate among controls is 0.27. If the true adenoma detection rate for experimental subjects is 0.35, the study will need 524 experimental subjects and 524 control subjects to be able to reject the null hypothesis that the adenoma detection rates for experimental and control subjects are equal with probability (power) 0.80. The Type I error probability associated with this test of this null hypothesis is 0.05. An uncorrected chi-squared statistic to evaluate this null hypothesis will be used.

Given the multiple stages of data collection in the interventional arm (at 1 week prior, -3 days prior, -1 day prior and morning of procedure) which may be burdensome as well as some patients who may not show up for the procedure, a drop-out rate of 10% will be anticipated. The adjusted sample size reflecting this is 1294. To account for these factors, we will aim to enrol 647 participants in both the interventional and control arms.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

31/03/2023

Actual

Date of last participant enrolment

Anticipated

30/09/2024

Actual

Date of last data collection

Anticipated

30/10/2024

Actual

Sample size

Target

1294

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Blacktown Hospital - Blacktown

Recruitment hospital [2]

Mount Druitt Hospital - Mount Druitt

Recruitment hospital [3]

Concord Repatriation Hospital - Concord

Recruitment hospital [4]

Campbelltown Hospital - Campbelltown

Recruitment postcode(s) [1]

2148 - Blacktown

Recruitment postcode(s) [2]

2770 - Mount Druitt

Recruitment postcode(s) [3]

2139 - Concord

Recruitment postcode(s) [4]

2560 - Campbelltown

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Western Sydney Local Health District, Westmead Hospital, Research Education Network

Address [1]

WSLHD Research and Education Network,
Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Norgine Pty Limited

Address [2]

Suite 3.01 Building A
20 Rodborough Road
Frenchs Forest NSW 2086 Australia

Country [2]

Australia

Primary sponsor type

Individual

Name

Dr Viraj Kariyawasam

Address

Blacktown Hospital
18 Blacktown Road
Blacktown NSW 2148

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Michael Au

Address [1]

Blacktown Hospital
18 Blacktown Road
Blacktown NSW 2148

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

WSLHD Human Research Ethics Committee 
Research Office
Level 2
REN Building
Westmead Hospital
Cnr Hawkesbury & Darcy Roads
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/01/2022

Approval date [1]

21/03/2022

Ethics approval number [1]

2022/ETH00059

Summary

Brief summary

This study aims to determine whether delivery of bowel preparation instructions for a colonoscopy through dynamic multimedia instructions (scheduled SMS, smartphone application, video instructions, and email) has an impact on the quality of bowel preparation, diagnosis rate and colonoscopy procedure times compared to instructions that are given verbally, in hard copy or via email only.

Who is it for?
You may be eligible for this study if you are aged 45 years or older, you have been scheduled to attend a colonoscopy as an outpatient to screen for potential colorectal cancer and you have access to a smartphone.

Study details
All participants will be instructed to take either a ‘Standard Bowel Preparation’ or 'Enhanced Bowel Preparation' depending upon their bowel habits. The only difference between the groups is how the instructions for bowel preparation will be delivered. All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to receive their bowel preparation instructions either by SMS, video and through a smartphone app, or to receive their instructions verbally, in paper/hard copy format or email only. Participants who are allocated to the SMS/smartphone group will receive 1-3 daily reminders throughout the week prior to their colonoscopy and will be asked to enter details about their preparation each day for 1 week prior to the colonoscopy. This should only take 2-5 minutes per day. Participants who are allocated to the paper/email group will receive a copy of the instructions once only and will not receive any reminders prior to their colonoscopy. All participants will be asked to complete a series of questionnaires after their colonoscopy, this is anticipated to take 10 minutes.

It is hoped this research will demonstrate whether a more interactive delivery of instructions for colonoscopy has any impact upon the ability to diagnose bowel cancer and the ease of the procedure itself. If this method is successful, it may be implemented on a larger scale which could improve the diagnosis and treatment of bowel cancers.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Viraj Kariyawasam

Address

Department of Gastroenterology and Hepatology
Blacktown Hospital
18 Blacktown Road
Blacktown NSW 2148

Country

Australia

Phone

+61 493 267 442

Fax

viraj.kariyawasam@health.nsw.gov.au

Contact person for public queries

Name

Michael Au

Address

Department of Gastroenterology and Hepatology
Blacktown Hospital
18 Blacktown Road
Blacktown NSW 2148

Country

Australia

Phone

+61 494 042 862

Fax

michael.au@health.nsw.gov.au

Contact person for scientific queries

Name

Michael Au

Address

Department of Gastroenterology and Hepatology
Blacktown Hospital
18 Blacktown Road
Blacktown NSW 2148

Country

Australia

Phone

+61 494 042 862

Fax

michael.au@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Not approved by Human Research Ethics Committee at the present time.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Email
16077	Ethical approval		michael.au@health.nsw.gov.au
16078	Informed consent form	https://bmjopen.bmj.com/content/13/7/e073843	michael.au@health.nsw.gov.au
16079	Study protocol	https://bmjopen.bmj.com/content/13/7/e073843	michael.au@health.nsw.gov.au

Results publications and other study-related documents

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