NCT02772250

Brief Summary

The study compares the efficacy of bowel preparation between the face-to-face re-education(FFRE group) and normal education (no-FFRE group) in patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
658

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

May 7, 2016

Last Update Submit

April 7, 2017

Conditions

Bowel Preparation

Keywords

bowel preparationpolyethylene glycolface-to-face re-educationtelephone re-educationBoston Bowel Preparation Scale

Outcome Measures

Primary Outcomes (1)

  • Adequate bowel preparation quality at the time of colonoscopy defined by Boston Bowel Preparation Scale rating scores≄6 among 2 groups.

    This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 2 groups.

    5 months

Secondary Outcomes (1)

  • Rate of compliance with instructions among 2 groups

    5 months

Other Outcomes (4)

  • Willingness to repeat bowel preparation among 2 groups.

    5 months

  • Polyp detection rate among 2 groups.

    5 months

  • Withdrawal time among 2 groups.

    5 months

  • +1 more other outcomes

Study Arms (2)

telephone re-education(TRE)

ACTIVE COMPARATOR

Subjects who are randomized into this group receive regular instructions at the time of their appointment to discuss colonoscopy (a nurse provides education of 5 minutes and meanwhilet sent a bookle to the patient) and a TRE which was conducted by a investigator at 15:00-17:00 on the day before colonoscopy.

Behavioral: telephone re-education(TRE)

face-to-face re-education (FFRE)

EXPERIMENTAL

Subjects who are randomized into this group receive regular instructions on the day of their appointment to discuss colonoscopy and also a FFRE which was conducted by a investigator on the same-day of procedure at hospital.

Behavioral: face-to-face re-education (FFRE)

Interventions

telephone re-education(TRE)BEHAVIORAL

Subjects who are randomized into this group receive regular instructions at the time of their appointment to discuss colonoscopy (a nurse provides education of 5 minutes and meanwhilet sent a bookle to the patient) and a TRE which was conducted by one investigator at 15:00-17:00 on the day before colonoscopy.

telephone re-education(TRE)
face-to-face re-education (FFRE)BEHAVIORAL

Subjects who are randomized into this group receive regular instructions on the day of their appointment to discuss colonoscopy and also a FFRE which was conducted by a investigator on the same-day of procedure at hospital.

face-to-face re-education (FFRE)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients aged 18-80 years undergoing colonoscopy who had provided written informed consent

You may not qualify if:

  • history of colorectal surgery
  • severe colonic stricture or obstructing tumour
  • dysphagia
  • compromised swallowing reflex or mental status
  • significant gastroparesis or gastric outlet obstruction or ileus
  • known or suspected bowel obstruction or perforation
  • severe chronic renal failure (creatinine clearance\<30 ml/min)
  • severe congestive heart failure (New York Heart Association class III or IV)
  • uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
  • toxic colitis or megacolon
  • dehydration
  • disturbance of electrolytes
  • pregnancy or lactation
  • unable to give informed consent
  • haemodynamically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Study Officials

  • li yanqing, PhD,MD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD,MD

Study Record Dates

First Submitted

May 7, 2016

First Posted

May 13, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

April 10, 2017

Record last verified: 2017-04

Locations

CN(1)