Bowel PreparationIERFAOBPNCT03225469
Improving Effect of Reinforced Family Assistance on the Quality of Bowel Preparation for Colonoscopy
A study testing reinforced family member education in people with Bowel Preparation, run by Wuxi People's Hospital.
Trial summary
Enhanced instructions such as re-education by telephone or short message which increase the patient adherence eventually improve the quality of bowel preparation significantly. However, the effect of family assistance which plays an essential role on compliance of patient with treatment on bowel preparation is… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- reinforced family member education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2017to 30 Apr 2018
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals scheduled for undergoing colonoscopy at the Endoscopy Center of Wuxi people's Hospital in China
- Greater than the age of 18
- Individuals living with other family members
- Outpatients
Who cannot join
- History of colorectal surgery
- Suspected or known digestive tract obstruction, stricture, or perforation
- Serious status of illness, such as severe renal failure whose creatinine clearance<30 ml/min, New York Heart Association grade III or grade IV congestive heart failure, or hemodynamic instability, etc.
- Incapable of completing bowel preparation，such as dysphagia, allergy to purgatives, or impaired mental status, etc.
- Pregnancy or breastfeeding
- Incomplete colonoscopy due to causes except poor bowel preparation
- Unable to give informed consent
- Have participated in the study before.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Improving Effect of Reinforced Family Member Education on the Quality of Bowel Preparation for Colonoscopy
Enhanced instructions such as re-education by telephone or short message which increase the patient adherence eventually improve the quality of bowel preparation significantly. However, the effect of family assistance which plays an essential role on compliance of patient with treatment on bowel preparation is unknown. The investigators hypothesized that reinforced education giving family members of outpatients will enhance family support to patients for colonoscopy, and consequently improve the quality of bowel preparation.
Therefore, the investigators designed protocols to reinforce family member education by verbal (face to face or telephone) and written methods. The aim of this study is to evaluate the effect of reinforced family member education on patient compliance and the quality of bowel preparation for colonoscopy. In addition，the rate of side effects happening, the subjective feelings of bowel preparation, the outcomes of colonoscopy ,and the independent risk factors will be also assessed.
Read the detailed description
Adequate bowel preparation is essential for optimal examination of the colorectal mucosa during colonoscopy. However, approximately 10%-30% bowel preparation is inadequate, leading to significantly decrease diagnostic accuracy and surveillance intervals, increase the procedural difficulties, and even increase the procedure-related complications. As reported, enhanced instructions such as re-education by telephone or short message which increase the patient adherence eventually improve the quality of bowel preparation significantly. However, the effect of family assistance which plays an essential role on compliance of patient with treatment on bowel preparation is unknown. The investigators hypothesized that reinforced education giving family members of outpatients will enhance family support to patients for colonoscopy, and consequently improve the quality of bowel preparation.
Therefore, the investigators designed protocols to reinforce family member education by verbal (face to face or telephone) and written methods. The aim of this study is to evaluate the effect of reinforced family member education on patient compliance and the quality of bowel preparation for colonoscopy. In addition，the rate of side effects happening, the subjective feelings of bowel preparation, the outcomes of colonoscopy ,and the independent risk factors will be also assessed.
This is a prospective, endoscopist-blinded, randomized, controlled study.
- Patients, Arm Description, Education and Blinding. Consecutive individuals over 18 years, who will be scheduled for undergoing colonoscopy between September and December 2017 at the Endoscopy Center of Wuxi people's Hospital in China and are not accord with the exclusion criteria will be enrolled in the study. After signature of informed consent, Patients will be consecutively randomized to either the reinforced family member education (RFME) or regular education (control) group at the time of colonoscopy appointments by opening a sealed opaque envelope. Regular instructions will be given to all patients during the colonoscopy appointment by one experienced endoscopy nurse. For RFME group, at least one family member who lives with the patient together will be given instruction at the basis of patent education. The information of group assignments will be keep from colonoscopists and other investigators at any time.
- Bowel preparation. Two kinds of purgatives, magnesium sulphate and polyethylene glycol electrolyte powder (PEG-ELP), are available in our endoscopy center, and the type will be prescribed by physician based on the conditions of the patient.
- Data collection and Definitions. On the day of colonoscopy, the patients will be asked to arrive at the Endoscopy Center 1 h before the procedure. The baseline data, clinical data and related data of the enrolled patients will be collected 1 h before the colonosc0py.
- Colonoscopy. All colonoscopy will be carried out between 13:30 and 16:30 by 5 five experienced endoscopists. The Boston Bowel Preparation Scale (BBPS) scoring system will be employed for the assessment of the quality of bowel preparation. The endoscopists will be asked to give the BBPS score immediately after the colonoscopy, and the findings of the colonoscopy, the cecal intubation, the insertion time, the withdrawal time and the incomplete examination cases not for poor bowel preparation will be recorded simultaneously.
- Statistical analysis. A total of 276 patients in each group will be required to obtain statistical significance for the primary outcome. Baseline characteristics, primary and secondary outcomes will be evaluated by intention-to-treat (ITT) analysis. To assess independent risk factors associated with inadequate bowel preparation, multivariate analysis will be conducted using the score of bowel preparation quality (BBPS <5) with a P value of ≤ 0.10 in the univariate analysis. All analyses will be carried out with SPSS software V.20.0 (SPSS Inc., Chicago, IL, USA). A P value of <0.05 was considered statistically significant.
- Conditions
- Bowel Preparation
- Being tested
- reinforced family member education
- Keywords
- Bowel Preparation, Colonoscopy, Quality, Family Support, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reinforced family member educationBehavioural
Also called reinforced family member instruction
Based on regular instructions for patent education, at least one family member who lives with the patient together will be given special instruction.
| Study group | Role | What they receive |
|---|---|---|
| reinforced family member education group | Experimental | Regular instructions will be given to all patients during the colonoscopy appointment. At least one family member who lives with the patient together will be given instruction at the basis of patent education. Receives: Behavioral: reinforced family member education |
| regular education group | No intervention | Regular instructions will be given to the patients during the colonoscopy appointment. There will be nothing specially for family members. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The qualified rate of bowel preparation
The score of Boston Bowel Preparation Scale = > 2 points for each region or = > 5 for the total colon will be considered as adequate bowel preparation to corresponding intestinal segments or total colon.
Measured: 5 months
Secondary outcomes (6)
Patient compliances
Compliance of dietary restrictions, integrity of purgatives ingestion, and water intake, are scored on a three-point scale based on a previous report with a little improvement, as follow：the estimated percentage of fulfilled instructions, high = > 70% getting 3point, moderate = 40% - 70% getting 2points, and low = <40% getting 1point.
Measured: 2 days
The level of family assistance
The level of family assistance is also scored on the three-point scale, = > 70% is defined as that the family member pay much attention to the colonoscopy, actively encourage, assist and supervise the patient to complete dietary preparation and bowel preparation according to the instruction. And 40% - 70% is that some certain extent supervision and reminders are provided by the family member but not actively, While = <40% is that the family member only know this examination, and very little encouragement and supervision are provided, or even worse.
Measured: 2 days
The subjective feelings of bowel preparation
The subjective feelings include sleep quality, anxiety levels, and willingness to repeat bowel preparation if necessary.
Measured: 2 days
The rate of cecal intubation
Proportion of successful cecal intubation individuals in total
Measured: 6 months.
The polyp detection rates
Proportion of polyp detection individuals in total
Measured: 6 months.
The insertion and withdrawal time.
The time of insertion and withdrawal during colonoscopy.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start15 Aug 2017 (estimated)
- Primary completion31 Mar 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies 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
- Model description
- reinforced family member education group, regular education (control) group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuxi People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Zhan, senior, Study director, Wuxi People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225469
- Sponsor's protocol ID
- Zql201706
- Acronym
- IERFAOBP
- Status last verified
- Jul 2017
- First submitted
- 15 Jul 2017
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Effect of Reinforced Family Member Education on the Quality of Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT03225469
- Acronym / sponsor ID
- IERFAOBP / Zql201706
- Conditions
- Bowel Preparation
- Keywords
- Bowel Preparation, Colonoscopy, Quality, Family Support, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- Wuxi People's HospitalUniversity, hospital or other
- Study start
- 15 Aug 2017 (estimated)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 21 Jul 2017 (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.
Enhanced instructions such as re-education by telephone or short message which increase the patient adherence eventually improve the quality of bowel preparation significantly. However, the effect of family assistance which plays an essential role on compliance of patient with treatment on bowel preparation is unknown. The investigators hypothesized that reinforced education giving family members of outpatients will enhance family support to patients for colonoscopy, and consequently improve the quality of bowel preparation.
Therefore, the investigators designed protocols to reinforce family member education by verbal (face to face or telephone) and written methods. The aim of this study is to evaluate the effect of reinforced family member education on patient compliance and the quality of bowel preparation for colonoscopy. In addition，the rate of side effects happening, the subjective feelings of bowel preparation, the outcomes of colonoscopy ,and the independent risk factors will be also assessed.
Detailed description
Adequate bowel preparation is essential for optimal examination of the colorectal mucosa during colonoscopy. However, approximately 10%-30% bowel preparation is inadequate, leading to significantly decrease diagnostic accuracy and surveillance intervals, increase the procedural difficulties, and even increase the procedure-related complications. As reported, enhanced instructions such as re-education by telephone or short message which increase the patient adherence eventually improve the quality of bowel preparation significantly. However, the effect of family assistance which plays an essential role on compliance of patient with treatment on bowel preparation is unknown. The investigators hypothesized that reinforced education giving family members of outpatients will enhance family support to patients for colonoscopy, and consequently improve the quality of bowel preparation.
Therefore, the investigators designed protocols to reinforce family member education by verbal (face to face or telephone) and written methods. The aim of this study is to evaluate the effect of reinforced family member education on patient compliance and the quality of bowel preparation for colonoscopy. In addition，the rate of side effects happening, the subjective feelings of bowel preparation, the outcomes of colonoscopy ,and the independent risk factors will be also assessed.
This is a prospective, endoscopist-blinded, randomized, controlled study.
- Patients, Arm Description, Education and Blinding. Consecutive individuals over 18 years, who will be scheduled for undergoing colonoscopy between September and December 2017 at the Endoscopy Center of Wuxi people's Hospital in China and are not accord with the exclusion criteria will be enrolled in the study. After signature of informed consent, Patients will be consecutively randomized to either the reinforced family member education (RFME) or regular education (control) group at the time of colonoscopy appointments by opening a sealed opaque envelope. Regular instructions will be given to all patients during the colonoscopy appointment by one experienced endoscopy nurse. For RFME group, at least one family member who lives with the patient together will be given instruction at the basis of patent education. The information of group assignments will be keep from colonoscopists and other investigators at any time.
- Bowel preparation. Two kinds of purgatives, magnesium sulphate and polyethylene glycol electrolyte powder (PEG-ELP), are available in our endoscopy center, and the type will be prescribed by physician based on the conditions of the patient.
- Data collection and Definitions. On the day of colonoscopy, the patients will be asked to arrive at the Endoscopy Center 1 h before the procedure. The baseline data, clinical data and related data of the enrolled patients will be collected 1 h before the colonosc0py.
- Colonoscopy. All colonoscopy will be carried out between 13:30 and 16:30 by 5 five experienced endoscopists. The Boston Bowel Preparation Scale (BBPS) scoring system will be employed for the assessment of the quality of bowel preparation. The endoscopists will be asked to give the BBPS score immediately after the colonoscopy, and the findings of the colonoscopy, the cecal intubation, the insertion time, the withdrawal time and the incomplete examination cases not for poor bowel preparation will be recorded simultaneously.
- Statistical analysis. A total of 276 patients in each group will be required to obtain statistical significance for the primary outcome. Baseline characteristics, primary and secondary outcomes will be evaluated by intention-to-treat (ITT) analysis. To assess independent risk factors associated with inadequate bowel preparation, multivariate analysis will be conducted using the score of bowel preparation quality (BBPS <5) with a P value of ≤ 0.10 in the univariate analysis. All analyses will be carried out with SPSS software V.20.0 (SPSS Inc., Chicago, IL, USA). A P value of <0.05 was considered statistically significant.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- reinforced family member education group, regular education (control) group
| Arm | Type | Receives |
|---|---|---|
| reinforced family member education group | Experimental | Behavioral: reinforced family member educationRegular instructions will be given to all patients during the colonoscopy appointment. At least one family member who lives with the patient together will be given instruction at the basis of patent education. |
| regular education group | No intervention | –Regular instructions will be given to the patients during the colonoscopy appointment. There will be nothing specially for family members. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals scheduled for undergoing colonoscopy at the Endoscopy Center of Wuxi people's Hospital in China
- Greater than the age of 18
- Individuals living with other family members
- Outpatients
Key exclusion criteria (8 listed)
- History of colorectal surgery
- Suspected or known digestive tract obstruction, stricture, or perforation
- Serious status of illness, such as severe renal failure whose creatinine clearance<30 ml/min, New York Heart Association grade III or grade IV congestive heart failure, or hemodynamic instability, etc.
- Incapable of completing bowel preparation，such as dysphagia, allergy to purgatives, or impaired mental status, etc.
- Pregnancy or breastfeeding
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 |
|---|---|---|
| reinforced family member educationAlso: reinforced family member instructionBased on regular instructions for patent education, at least one family member who lives with the patient together will be given special instruction. | Behavioural | reinforced family member education group |
Primary outcome
The qualified rate of bowel preparation
Time frame: 5 months
The score of Boston Bowel Preparation Scale = > 2 points for each region or = > 5 for the total colon will be considered as adequate bowel preparation to corresponding intestinal segments or total colon.
6 secondary outcomes
Patient compliances
Time frame: 2 days
The level of family assistance
Time frame: 2 days
The subjective feelings of bowel preparation
Time frame: 2 days
The rate of cecal intubation
Time frame: 6 months.
The polyp detection rates
Time frame: 6 months.
The insertion and withdrawal time.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Bowel Preparation
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Not yet recruiting
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer, Rectal Adenocarcinoma
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
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.
Qiang Zhan, senior study director
Wuxi People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing reinforced family member education in people with Bowel Preparation, run by Wuxi People's 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 8 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 14 Aug 2017. 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 Qinglin Zhang, resident (15358011815, zhang517068@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The qualified rate of bowel preparation (time frame: 5 months). 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 14 Aug 2017.