NCT03225469

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
552

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

August 14, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

July 15, 2017

Last Update Submit

August 10, 2017

Conditions

Bowel Preparation

Keywords

Bowel PreparationColonoscopyQualityFamily SupportEducation

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 months

Secondary Outcomes (6)

  • Patient compliances

    2 days

  • The level of family assistance

    2 days

  • The subjective feelings of bowel preparation

    2 days

  • The rate of cecal intubation

    6 months.

  • The polyp detection rates

    6 months.

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

reinforced family member educationBEHAVIORAL

Based on regular instructions for patent education, at least one family member who lives with the patient together will be given special instruction.

Also known as: reinforced family member instruction
reinforced family member education group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Qiang Zhan, senior

    Wuxi People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Qinglin Zhang, resident

CONTACT

15358011815zhang517068@126.com

Qiang Zhan, senior

CONTACT

13961850282zhanq33@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The patients and the associated family members know which group they are assigned，while the colonoscopist, information collector are blinded to group assignment.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: reinforced family member education group, regular education (control) group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2017

First Posted

July 21, 2017

Study Start

August 15, 2017

Primary Completion

March 31, 2018

Study Completion

April 30, 2018

Last Updated

August 14, 2017

Record last verified: 2017-07