NCT03642652

Brief Summary

A randomized controlled trial to examine the effect of 3 mobile telephone text message reminders on followup colonoscopy 120 days after a positive fecal occult blood test among Meuhedet members aged 50-74 who tested positive in 2016.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
470

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable colorectal-cancer

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

April 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

August 21, 2018

Last Update Submit

August 22, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Follow-up colonoscopy 120 days after a positive fecal occult blood test

    Completion of colonoscopy

    120 days after positive FOBT

Study Arms (2)

SMS

EXPERIMENTAL

Each patient in the intervention group also received an automated text message up to a week after the positive FOBT result. The text read: "Hello. There is a lab test result ready for you. Contact your physician for an explanation of the findings." Two additional automated text message reminders were sent to the patient at 2 weeks and 1 month reading, "Hello, This is a reminder. It is essential that you contact your physician if you have not already done so."

Behavioral: SMS

Control

NO INTERVENTION

Routine care

Interventions

SMSBEHAVIORAL

Text reminders to mobile telephone

Also known as: mobile text reminder
SMS

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • positive fecal occult blood test (FOBT) in 2016
  • agreed to receive SMS from healthcare provider

You may not qualify if:

  • Existing oncology diagnosis
  • personal or family history of colorectal cancer
  • colonoscopy up to 10 years prior to FOBT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Azulay R, Valinsky L, Hershkowitz F, Magnezi R. Repeated Automated Mobile Text Messaging Reminders for Follow-Up of Positive Fecal Occult Blood Tests: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Feb 5;7(2):e11114. doi: 10.2196/11114.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants were not aware of the trial. Only Intervention arm participants received text reminders
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Randomisation into Intervention and control groups. Text message sent to Intervention group. No intervention in control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 22, 2018

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

August 24, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share