CClinicalTrials.gg
Status unknownNCT04052750Updated Aug 12, 2019

SMS Reminders and Treatment Compliance and Efficacy in Patients With FGIDs

An interventional study of SMS follow-up in Functional Gastrointestinal Disorders and Patient Compliance, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-08-12.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2019, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
176
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Functional Gastrointestinal Disorders
  • Patient Compliance

Keywords

  • Functional Gastrointestinal Disorders, Adherence
03

In context

Gastrointestinal Diseases

628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.

This study's planned enrollment of 176 is above the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

Exclusion Criteria:

  • With organic gastrointestinal diseases
  • With psychiatric diseases or are taking psychotropic agents
  • With severe cardiopulmonary or other organ diseases
  • Pregnant women
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
176 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralSMS follow-up

    In addition to conventional treatment, the experimental group received SMS reminding every day until the end of the treatment.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: week2

Secondary outcomes

  1. 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.

    Time frame: week2

07

Study locations

1 of 1 sites recruiting
  • RenJiH
    Shanghai, China
    Recruiting
08

References and documents

Publications

  • Wang B, Luo QQ, Li Q, Cheng L, Chen SL. Daily Short Message Service Reminders Increase Treatment Compliance and Efficacy in Outpatients with Functional Dyspepsia: a Prospective Randomized Controlled Trial. J Gen Intern Med. 2020 Oct;35(10):2925-2931. doi: 10.1007/s11606-020-06088-3. Epub 2020 Aug 10. PubMed 32779141 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04052750
Lead sponsor
RenJi Hospital
Responsible party
Shengliang Chen (professor,chief physician, RenJi Hospital) — Principal investigator
First posted
Aug 12, 2019
Start date
Apr 30, 2019
Primary completion
Apr 30, 2020 (estimated)
Completion
Apr 30, 2021 (estimated)
Last update
Aug 12, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion