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Trial record 90 of 663 for:    SMS

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
Sponsor:
Information provided by (Responsible Party):
Meuhedet. Healthcare Organization

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: SMS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 470 participants
Allocation: Randomized
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
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: 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."
Behavioral: SMS
Text reminders to mobile telephone
Other Name: mobile text reminder

No Intervention: Control
Routine care



Primary Outcome Measures :
  1. Follow-up colonoscopy 120 days after a positive fecal occult blood test [ Time Frame: 120 days after positive FOBT ]
    Completion of colonoscopy



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Meuhedet. Healthcare Organization
ClinicalTrials.gov Identifier: NCT03642652     History of Changes
Other Study ID Numbers: 01-023-03-16
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases