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SMS Reminders and Treatment Compliance and Efficacy in Patients With FGIDs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04052750
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Information provided by (Responsible Party):
Shengliang Chen, RenJi Hospital

Brief Summary:
The effect of SMS follow-up on drug compliance and efficacy in patients with FGIDs has not been reported in the literature. We, therefore, conducted a prospective randomized controlled trial to investigate whether SMS follow-up could improve treatment adherence in patients with FGIDs, which in turn would help symptom relief and improve treatment outcomes.

Condition or disease Intervention/treatment Phase
Functional Gastrointestinal Disorders Patient Compliance Behavioral: SMS follow-up Not Applicable

Detailed Description:
The irritable bowel syndrome (IBS) and other functional gastrointestinal disorders (FGIDs) are common and pose significant burdens to patients. Although regular medications have substantial benefits for disease remission, many patients do not follow the recommendations of standard medication regimens given by physicians at the time of the visit, so how to improve patient compliance becomes even more important. Many factors can affect drug compliance. Forgetting seems to be one of the important reasons for poor compliance. In order to solve this problem, many studies such as drug charts/calendars, mini kits, etc. have been conducted in previous studies. At present, with the popularization of mobile phones, SMS-based interventions are gradually being applied to various medical environments. Compared with the phone, SMS consumes less time and can be easily integrated into the patient's daily life. Therefore, short messages may be more suitable for follow-up of patients outside hospital.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Daily Short Message Service Reminders Increase Treatment Compliance and Efficacy in Outpatients With Functional Gastrointestinal Disorders: a Randomized Controlled Trial
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: The control group
Patients in this group only received medications without daily text message reminder
Experimental: The intervention group
Patients in this group received a daily short message service (SMS) reminder when medications were prescribed
Behavioral: SMS follow-up
In addition to conventional treatment, the experimental group received SMS reminding every day until the end of the treatment.

Primary Outcome Measures :
  1. Treatment compliance in outpatients with FGIDs [ Time Frame: week2 ]
    Compliance is assessed by the medication possession ratio (MPR). The MPR is often defined as the sum of the days' supply of medication divided by the number of days between the first fill and the last refill plus the days' supply of the last refill. This calculation usually results in a ratio less than 1.0 if there are lapses in prescription refilling.

Secondary Outcome Measures :
  1. Improvement of abdominal pain in outpatients with FGIDs [ Time Frame: week2 ]
    Improvement of abdominal pain symptom was assessed by comparison of symptom score after treatment to that before treatment. The pain symptome was assessed by Visual Analog Score for pain with the following creteria: 0, no pain; 1, mild; 2, related; 3, severe; 4, very severe. Higher values represent a worse outcome.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with newly diagnosed FGIDs according to Rome-IV
  • Aged 18-70 years
  • With no obvious organic abnormalities

Exclusion Criteria:

  • With organic gastrointestinal diseases
  • With psychiatric diseases or are taking psychotropic agents
  • With severe cardiopulmonary or other organ diseases
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04052750

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RenJiH Recruiting
Shanghai, China
Contact: Shengliang Chen    86-21-58752345   
Sponsors and Collaborators
RenJi Hospital

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Responsible Party: Shengliang Chen, professor,chief physician, RenJi Hospital Identifier: NCT04052750     History of Changes
Other Study ID Numbers: RJYYXHNK-004
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shengliang Chen, RenJi Hospital:
Functional Gastrointestinal Disorders, Adherence
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases