SMS Reminders and Treatment Compliance and Efficacy in Patients With FGIDs

Functional Gastrointestinal Disorders Clinical Trial

Official title:

Daily Short Message Service Reminders Increase Treatment Compliance and Efficacy in Outpatients With Functional Gastrointestinal Disorders: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04052750
• Other study ID #: RJYYXHNK-004
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: August 2019
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Patient Compliance

Intervention

Behavioral:
• SMS follow-up
In addition to conventional treatment, the experimental group received SMS reminding every day until the end of the treatment.

Locations

Country	Name	City	State
China	RenJiH	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment compliance in outpatients with FGIDs	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.	week2
Secondary	Improvement of abdominal pain in outpatients with FGIDs	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.	week2