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SMS Reminders for Positive FOBT Follow-up

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SMS
Sponsored by
Meuhedet. Healthcare Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    SMS

    Control

    Arm Description

    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."

    Routine care

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 21, 2018
    Last Updated
    August 22, 2018
    Sponsor
    Meuhedet. Healthcare Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03642652
    Brief Title
    SMS Reminders for Positive FOBT Follow-up
    Official Title
    Repeated Automated Mobile Text Reminders for Follow-up of Positive Fecal Occult Blood Tests: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    April 1, 2017 (Actual)
    Study Completion Date
    May 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Meuhedet. Healthcare Organization

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Background: Fecal occult blood tests are recommended by the US Preventive Services Task Force as a screening method for colorectal cancer, but they are only effective if positive results are followed by colonoscopy. Surprisingly, a large proportion of patients with a positive result do not follow this recommendation. Objective: To examine the effectiveness of a short message service in increasing adherence to colonoscopy follow-up after a positive fecal occult blood test. Methods: This randomized controlled trial was conducted with patients who had positive colorectal cancer screening results. Randomization was stratified by residential district and socioeconomic status. Subjects in the control group (n = 238) received routine care that included an alert to the physician regarding the positive Fecal occult blood test result. The intervention group (n = 232) received routine care and three short message service reminders to visit their primary care physician. Adherence to colonoscopy was measured 120 days from the positive result. All patient information, including test results and colonoscopy completion, were obtained from their computerized medical records. Physicians of the study patients completed an attitude survey regarding FOBT as a screening test for colorectal cancer. The intervention and control groups were compared using chi-squared for discrete variables. Logistic regression was used to calculate odds ratios and 95% confidence intervals for performing colonoscopy within 120 days, adjusting for potential confounders of age, gender, socioeconomic status, district, ethnicity, intervention group and physician's attitude.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomisation into Intervention and control groups. Text message sent to Intervention group. No intervention in control group
    Masking
    ParticipantCare Provider
    Masking Description
    Participants were not aware of the trial. Only Intervention arm participants received text reminders
    Allocation
    Randomized
    Enrollment
    470 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SMS
    Arm Type
    Experimental
    Arm Description
    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."
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Routine care
    Intervention Type
    Behavioral
    Intervention Name(s)
    SMS
    Other Intervention Name(s)
    mobile text reminder
    Intervention Description
    Text reminders to mobile telephone
    Primary Outcome Measure Information:
    Title
    Follow-up colonoscopy 120 days after a positive fecal occult blood test
    Description
    Completion of colonoscopy
    Time Frame
    120 days after positive FOBT

    10. Eligibility

    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: positive fecal occult blood test (FOBT) in 2016 agreed to receive SMS from healthcare provider Exclusion Criteria: Existing oncology diagnosis personal or family history of colorectal cancer colonoscopy up to 10 years prior to FOBT

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30720439
    Citation
    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.
    Results Reference
    derived

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