SMS Reminders for Positive FOBT Follow-up
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|ClinicalTrials.gov Identifier: NCT03642652|
Recruitment Status : Completed
First Posted : August 22, 2018
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Behavioral: SMS||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||470 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomisation into Intervention and control groups. Text message sent to Intervention group. No intervention in control group|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||Participants were not aware of the trial. Only Intervention arm participants received text reminders|
|Official Title:||Repeated Automated Mobile Text Reminders for Follow-up of Positive Fecal Occult Blood Tests: a Randomized Controlled Trial|
|Actual Study Start Date :||April 1, 2016|
|Actual Primary Completion Date :||April 1, 2017|
|Actual Study Completion Date :||May 1, 2017|
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."
Text reminders to mobile telephone
Other Name: mobile text reminder
No Intervention: Control
- Follow-up colonoscopy 120 days after a positive fecal occult blood test [ Time Frame: 120 days after positive FOBT ]Completion of colonoscopy