SMS Reminders and Treatment Compliance and Efficacy in Patients With FGIDs

Not Applicable

• Conditions: Functional Gastrointestinal Disorders; Patient Compliance
• Interventions: Behavioral: SMS follow-up

• Registration Number: NCT04052750
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2019-04-30
• Status Verified: 2019-08
• Study First Submitted: 2019-08-03
• Study First Submitted QC: 2019-08-09
• Last Update Submitted: 2019-08-09
• Study First Posted: 2019-08-12
• Last Update Posted: 2019-08-12
• Primary Completion: 2020-04-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The intervention group	SMS follow-up	Patients in this group received a daily short message service (SMS) reminder when medications were prescribed

Primary Outcome Measures

Name	Time	Method
Treatment compliance in outpatients with FGIDs	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

Name	Time	Method
Improvement of abdominal pain in outpatients with FGIDs	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.

Trial Locations

Locations (1)

RenJiH; 🇨🇳 Shanghai, China