Colonoscopy Motivation for Patients With Positive Immunochemical Fecal Test
Colofit+
Evaluation of a Motivational Phone Call Strategy to Improve Colonoscopy Participation, for Patients With a Positive Immunochemical Fecal Test : Colofit + Study
1 other identifier
interventional
127
1 country
1
Brief Summary
Patients with an immunochemical fecal test positive, have to undergo a colonoscopy. Around 10% doesn't realize the colonoscopy. This study evaluate the impact of a motivational phone call (given by a doctor) to improve colonoscopy participation. And try to understand why this patients don't want to make this examination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
May 23, 2017
CompletedFirst Submitted
Initial submission to the registry
September 6, 2017
CompletedFirst Posted
Study publicly available on registry
September 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2018
CompletedJuly 3, 2018
July 1, 2018
7 months
September 6, 2017
July 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participation to the colonoscopy
Colonoscopy done six months after our phone call
From date of phone call until the date of first documented colonoscopy assessed up to 6 months
Secondary Outcomes (2)
reasons for rejecting colonoscopy
Reasons for rejecting colonoscopy will be assessed during the phone call only, and assessed until the end of this phone call
cancer and adenoma detected
From date of phone call until the date of first documented colonoscopy result assessed up to 6 months after phone call
Study Arms (1)
COLOFIT+ Study
EXPERIMENTALPersonnalized motivational phone call, done by a medical physician
Interventions
Personnalized phone call, done by the medical student in the name of Adémas-69, organized cancers screening in the Rhône area association. This is a motivational call to encourage patients with an immunochemical fecal test positive, to realized their colonoscopy.
Eligibility Criteria
You may qualify if:
- immunochemical fecal test positive but no colonoscopy performed despite a full sequence of reminder (3 letters)
You may not qualify if:
- colonoscopy done
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ademas-69
Lyon, 69005, France
Related Publications (1)
Gandilhon C, Soler-Michel P, Vecchiato L, Chaunier C, Fay I, Walter T, Rivory J, Saurin JC, Ponchon T, Pioche M. A motivational phone call improves participation to screening colonoscopy for those with a positive FIT in a national screening programme (NCT 03276091). Dig Liver Dis. 2018 Dec;50(12):1309-1314. doi: 10.1016/j.dld.2018.08.007. Epub 2018 Aug 17.
PMID: 30197186DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thierry Ponchon, PHD
Hopital Edouard Herriot
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- ADEMAS69
Study Record Dates
First Submitted
September 6, 2017
First Posted
September 8, 2017
Study Start
May 23, 2017
Primary Completion
December 31, 2017
Study Completion
March 16, 2018
Last Updated
July 3, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share