NCT02534142

Brief Summary

Approximately 40% of members with a positive fecal occult blood result do not continue to followup colonoscopy in Meuhedet. The purpose of this study is to identify the structural, process, carer and patient related causes of undertreatment and suggest appropriate organisational interventions. Using both quantitative and qualitative methods, the investigators will identify organisational and personal barriers to completion of followup of positive FOBT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
774

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

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

First Submitted

Initial submission to the registry

July 28, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

July 28, 2015

Last Update Submit

August 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Variables related to non-completion of colonoscopy following a positive fecal occult blood test

    Quantitative and qualitative variables associated with non-completion of colonoscopical followup among members with a positive screening fecal occult test result: Availability and distance variables (hours, kms), Patient knowledge and awareness (questionnaire scores), Physician knowledge and awareness (qualitative data),

    18 months

Study Arms (2)

Completed followup

All members aged 50-74 who completed a fecal occult blood test between 1/1/2014 and 1/1/2015, who had a positive result and had a colonoscopy following the result.

Did not complete followup

All members aged 50-74 who completed a fecal occult blood test between 1/1/2014 and 1/1/2015, who had a positive result and did not have a colonoscopy following the result.

Eligibility Criteria

Age51 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

a representative sample of Meuhedet members who adhered / did not adhere to followup of a positive fecal occult blood test using colonoscopy

You may qualify if:

  • Members of MHC aged 50-74 who completed a fecal occult blood test during the study period.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meuhedet

Tel Aviv, Israel

Location

Related Publications (1)

  • Azulay R, Valinsky L, Hershkowitz F, Magnezi R. Is the patient activation measure associated with adherence to colonoscopy after a positive fecal occult blood test result? Isr J Health Policy Res. 2018 Dec 21;7(1):74. doi: 10.1186/s13584-018-0270-8.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Revital Azulay, MSC

    Meuhedet Health Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2015

First Posted

August 27, 2015

Study Start

October 1, 2015

Primary Completion

February 1, 2017

Study Completion

December 20, 2017

Last Updated

August 22, 2018

Record last verified: 2018-08

Locations