ColonoscopyNCT05734079
Impact of Digital Tools on the Quality of Bowel Preparation for Colonoscopy
A study of Colonoscopy, run by Ziv Hospital.
Trial summary
This is a single blinded randomized controlled study. The main question of this study is whether better preparation by making full use of digital tools can increase patient compliance with the preparation methods for colonoscopy, and as a result improve bowel preparation quality and colonoscopy outcomes in a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 825 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >18 years
- access to a digital device (smart phone, tablet, personal computer, laptop- this includes individuals who can use devices from household of relatives)
- ability to understand instructions in Hebrew or Arabic
- ability to sign a digital consent
Who cannot join
- pregnancy (first trimester)
Trial locations and contacts
No sites are listed yet.
About this study
This is a single blinded randomized controlled study. The main question of this study is whether better preparation by making full use of digital tools can increase patient compliance with the preparation methods for colonoscopy, and as a result improve bowel preparation quality and colonoscopy outcomes in a cost-effective manner.
Participants will randomly assigned to one of three colonoscopy preparation groups (i) a written hand out containing all information required for bowel preparation (standard care) (ii) standard care and in addition a video call with a professional nurse conducted via digital devices and a free software (Zoom video communication or What's app application) (iii) standard care and in addition to a video call as described above using an explanatory short video on bowel preparation (video film), streamed to the patient's mobile device or computer.
Read the detailed description
Adequate bowel preparation is crucial for a successful and effective colonoscopy examination. Nevertheless, poor bowel preparation in patients is common and may lead to a lower quality of the examination that means a reduction in the rate of cecum intubation and lower detection rate of early and advanced adenoma. Finally, poor bowel preparation can lead to an abruption of the examination.
Digital advancement has been made in the context of colonoscopy bowel preparation, however high quality studies are still needed Ziv Medical Centre (ZMC) is a 300 bed governmental hospital located in Safed, Northern Israel that serves a diverse population. The gastroenterology department carries out approximately 1300 colonoscopies per year. A rapid audit has shown that approximately 15% of colonoscopies are stopped and up to 40% are incomplete, partly as a result of sub-optimal preparation.
The aim of this study is to determine whether better preparation by making full use of digital tools can increase patient compliance with the preparation methods for colonoscopy, and as a result improve bowel preparation quality and colonoscopy outcomes in a cost-effective manner.
This single blinded randomized controlled trial compares the effectiveness of bowel preparation in participants randomly assigned to one of three colonoscopy preparation groups (i) a written hand out containing all information required for bowel preparation (standard care) (ii) standard care and in addition a video call with a professional nurse conducted via digital devices and a free software (Zoom video communication or What's app application) (iii) standard care and in addition to a video call as described above using an explanatory short video on bowel preparation (video film), streamed to the patient's mobile device or computer.
All patients included in the trial will receive standard care 10 days before the examination. Patients randomized to the groups with a video call or a video call + video film will be contacted by a nurse to determine an appointment to the 10th day before examination. Patients randomized to the study arm including an educational video film will be sent a link to the video film after the video call. On the day of the exam, during the examination, the medical doctor records an OBPS score as described. After the exam, the medical doctor will register whether the exam was complete, incomplete, stopped and whether hospitalization was needed. After the examination and recovery, all patients will receive a short satisfaction questionnaire.
- Conditions
- Colonoscopy
- Being tested
- Standard of care, Standard of care + Video call, Standard of care + Video call + Educational video film
- Keywords
- colonoscopy, gastroenterology, bowel preparation, digital, colorectal cancer screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
A written hand out containing all information required for bowel preparation
Standard of care + Video callOther
Standard of care and in addition a video call with a professional nurse conducted via digital devices and a free software (Zoom video communication or What's app application)
Standard of care + Video call + Educational video filmOther
Standard of care and in addition to a video call, an explanatory short video on bowel preparation (video film), streamed to the patient's mobile device or computer
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Standard of care includes a written paper sheet that summarizes information about the colonoscopy procedure and bowel preparation. Receives: Other: Standard of care |
| Standard of care + Video call | Experimental | The video call will be performed at a designated time with a GE educated nurse. The purpose of the video call is (i) to clarify the patient in person about the colonoscopy procedure (ii) efficiently prepare the patient for bowel preparation by; asking the patient about her/his medical condition, the indication for colonoscopy, medical history, current medical status and medications currently taken. The patient will be inquired, whether she/he went through colonoscopy in the past, what preparation methods were undertaken and what the outcome of the examination was. Based on the information collected during the conversation, the designated nurse performing the interview will tailor the method of bowel preparation for the patient in terms of kind of relaxant, adjustment of medication intake and dietary adjustments before the examination. Receives: Other: Standard of care + Video call |
| Standard of care + Video call + Educational video film | Experimental | The video film will explain the colonoscopy procedure and the bowel preparation procedure, in layman's terms and in the patient's preferred language (Hebrew or Arabic). Receives: Other: Standard of care + Video call + Educational video film |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Ottawa Bowel Preparation Scale (OBPS)
A standard method used to assess a patient's bowel preparation for colonoscopies. The bowel preparation score is a sum of a segmental score (right-colon, mid-colon and rectosigmoid-colon) and a fluid quantity score. The segmental score is quantified on a scale of 0 to 4, with; 0 indicating perfect cleansing, 1 indicating good cleansing, 2 indicating Fair cleansing, 3 indicating poor cleansing and 4 indicating inadequate cleansing. Overall fluid quantity is quantified on a scale of 0 to 2, with; 0 indicating no fluid in the colon and 2 indicating a large amount of fluid in the colon. Both the colon score and fluid score result in an overall score ranging from 0 to 14, with; 0 an Excellent cleansing quality and 14 indicates the worst cleansing quality. Estimations of the scores are made by the medical doctors during the exam and are fed into a commercial software that calculates the overall OBPS score.
Measured: OBPS will be evaluated during the colonoscopy procedure
Secondary outcomes (3)
Patient's satisfaction questionaire
Patients will be asked about various aspects of the preparation using likert scales- the scores for each question will be compared across groups. The questionaires will include several questions about demographic background such as education level and occupation.
Measured: Questionnaires will be given to the patients immediately after the colonoscopy
Colonoscopy completion
The proportion of successfully completed colonoscopies will be quantified.
Measured: Colonoscopy completion will be recorded for 1 year
The proportional change in the annual cost of treatment services
The proportional change in the annual cost of running the service will be calculated, taking into account costs (research nurse, cost of developing the video etc.) and saving (averted complications, failed colonoscopies requiring re-booking etc.)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 825 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Toni Ashqar, Ziv Hospital
- Investigators
- Toni Ashqar, Dr., Principal investigator, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734079
- Sponsor's protocol ID
- 0085-22-ZIV
- Status last verified
- Feb 2023
- First submitted
- 10 Jan 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Digital Tools on the Quality of Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT05734079
- Acronym / sponsor ID
- 0085-22-ZIV
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, gastroenterology, bowel preparation, digital, colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 825 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single blinded randomized controlled study. The main question of this study is whether better preparation by making full use of digital tools can increase patient compliance with the preparation methods for colonoscopy, and as a result improve bowel preparation quality and colonoscopy outcomes in a cost-effective manner.
Participants will randomly assigned to one of three colonoscopy preparation groups (i) a written hand out containing all information required for bowel preparation (standard care) (ii) standard care and in addition a video call with a professional nurse conducted via digital devices and a free software (Zoom video communication or What's app application) (iii) standard care and in addition to a video call as described above using an explanatory short video on bowel preparation (video film), streamed to the patient's mobile device or computer.
Detailed description
Adequate bowel preparation is crucial for a successful and effective colonoscopy examination. Nevertheless, poor bowel preparation in patients is common and may lead to a lower quality of the examination that means a reduction in the rate of cecum intubation and lower detection rate of early and advanced adenoma. Finally, poor bowel preparation can lead to an abruption of the examination.
Digital advancement has been made in the context of colonoscopy bowel preparation, however high quality studies are still needed Ziv Medical Centre (ZMC) is a 300 bed governmental hospital located in Safed, Northern Israel that serves a diverse population. The gastroenterology department carries out approximately 1300 colonoscopies per year. A rapid audit has shown that approximately 15% of colonoscopies are stopped and up to 40% are incomplete, partly as a result of sub-optimal preparation.
The aim of this study is to determine whether better preparation by making full use of digital tools can increase patient compliance with the preparation methods for colonoscopy, and as a result improve bowel preparation quality and colonoscopy outcomes in a cost-effective manner.
This single blinded randomized controlled trial compares the effectiveness of bowel preparation in participants randomly assigned to one of three colonoscopy preparation groups (i) a written hand out containing all information required for bowel preparation (standard care) (ii) standard care and in addition a video call with a professional nurse conducted via digital devices and a free software (Zoom video communication or What's app application) (iii) standard care and in addition to a video call as described above using an explanatory short video on bowel preparation (video film), streamed to the patient's mobile device or computer.
All patients included in the trial will receive standard care 10 days before the examination. Patients randomized to the groups with a video call or a video call + video film will be contacted by a nurse to determine an appointment to the 10th day before examination. Patients randomized to the study arm including an educational video film will be sent a link to the video film after the video call. On the day of the exam, during the examination, the medical doctor records an OBPS score as described. After the exam, the medical doctor will register whether the exam was complete, incomplete, stopped and whether hospitalization was needed. After the examination and recovery, all patients will receive a short satisfaction questionnaire.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Standard of careStandard of care includes a written paper sheet that summarizes information about the colonoscopy procedure and bowel preparation. |
| Standard of care + Video call | Experimental | Other: Standard of care + Video callThe video call will be performed at a designated time with a GE educated nurse. The purpose of the video call is (i) to clarify the patient in person about the colonoscopy procedure (ii) efficiently prepare the patient for bowel preparation by; asking the patient about her/his medical condition, the indication for colonoscopy, medical history, current medical status and medications currently taken. The patient will be inquired, whether she/he went through colonoscopy in the past, what preparation methods were undertaken and what the outcome of the examination was. Based on the information collected during the conversation, the designated nurse performing the interview will tailor the method of bowel preparation for the patient in terms of kind of relaxant, adjustment of medication intake and dietary adjustments before the examination. |
| Standard of care + Video call + Educational video film | Experimental | Other: Standard of care + Video call + Educational video filmThe video film will explain the colonoscopy procedure and the bowel preparation procedure, in layman's terms and in the patient's preferred language (Hebrew or Arabic). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >18 years
- access to a digital device (smart phone, tablet, personal computer, laptop- this includes individuals who can use devices from household of relatives)
- ability to understand instructions in Hebrew or Arabic
- ability to sign a digital consent
Key exclusion criteria (1 listed)
- pregnancy (first trimester)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careA written hand out containing all information required for bowel preparation | Other | Standard of care |
| Standard of care + Video callStandard of care and in addition a video call with a professional nurse conducted via digital devices and a free software (Zoom video communication or What's app application) | Other | Standard of care + Video call |
| Standard of care + Video call + Educational video filmStandard of care and in addition to a video call, an explanatory short video on bowel preparation (video film), streamed to the patient's mobile device or computer | Other | Standard of care + Video call + Educational video film |
Primary outcome
The Ottawa Bowel Preparation Scale (OBPS)
Time frame: OBPS will be evaluated during the colonoscopy procedure
A standard method used to assess a patient's bowel preparation for colonoscopies. The bowel preparation score is a sum of a segmental score (right-colon, mid-colon and rectosigmoid-colon) and a fluid quantity score. The segmental score is quantified on a scale of 0 to 4, with; 0 indicating perfect cleansing, 1 indicating good cleansing, 2 indicating Fair cleansing, 3 indicating poor cleansing and 4 indicating inadequate cleansing. Overall fluid quantity is quantified on a scale of 0 to 2, with; 0 indicating no fluid in the colon and 2 indicating a large amount of fluid in the colon. Both the colon score and fluid score result in an overall score ranging from 0 to 14, with; 0 an Excellent cleansing quality and 14 indicates the worst cleansing quality. Estimations of the scores are made by the medical doctors during the exam and are fed into a commercial software that calculates the overall OBPS score.
3 secondary outcomes
Patient's satisfaction questionaire
Time frame: Questionnaires will be given to the patients immediately after the colonoscopy
Colonoscopy completion
Time frame: Colonoscopy completion will be recorded for 1 year
The proportional change in the annual cost of treatment services
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toni Ashqar, Dr. principal investigator
Ziv Medical Center
Questions about this trial
What is this clinical trial studying?
A study of Colonoscopy, run by Ziv Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Toni Ashqar, Dr. (+972528225103, toniashqar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Ottawa Bowel Preparation Scale (OBPS) (time frame: OBPS will be evaluated during the colonoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.