SMS Reminders for Positive FOBT Follow-up

NCT ID: NCT03642652

Last Updated: 2018-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-05-01

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomisation into Intervention and control groups. Text message sent to Intervention group. No intervention in control group
Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Caregivers
Participants were not aware of the trial. Only Intervention arm participants received text reminders

Study Groups

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SMS

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."

Group Type EXPERIMENTAL

SMS

Intervention Type BEHAVIORAL

Text reminders to mobile telephone

Control

Routine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SMS

Text reminders to mobile telephone

Intervention Type BEHAVIORAL

Other Intervention Names

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mobile text reminder

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Meuhedet. Healthcare Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 30720439 (View on PubMed)

Other Identifiers

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01-023-03-16

Identifier Type: -

Identifier Source: org_study_id

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