SMS Reminders for Positive FOBT Follow-up
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SMS
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer
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
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
NCT ID
NCT03642652
First Posted
August 21, 2018
Last Updated
August 22, 2018
Sponsor
Meuhedet. Healthcare Organization
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
Learn more about this trial
SMS Reminders for Positive FOBT Follow-up
We'll reach out to this number within 24 hrs