SMS Reminders and Treatment Compliance and Efficacy in Patients With FGIDs
Primary Purpose
Functional Gastrointestinal Disorders, Patient Compliance
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SMS follow-up
Sponsored by
About this trial
This is an interventional treatment trial for Functional Gastrointestinal Disorders focused on measuring Functional Gastrointestinal Disorders, Adherence
Eligibility Criteria
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
Sites / Locations
- RenJiHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
The control group
The intervention group
Arm Description
Patients in this group only received medications without daily text message reminder
Patients in this group received a daily short message service (SMS) reminder when medications were prescribed
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04052750
Brief Title
SMS Reminders and Treatment Compliance and Efficacy in Patients With FGIDs
Official Title
Daily Short Message Service Reminders Increase Treatment Compliance and Efficacy in Outpatients With Functional Gastrointestinal Disorders: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders, Patient Compliance
Keywords
Functional Gastrointestinal Disorders, Adherence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
176 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The control group
Arm Type
No Intervention
Arm Description
Patients in this group only received medications without daily text message reminder
Arm Title
The intervention group
Arm Type
Experimental
Arm Description
Patients in this group received a daily short message service (SMS) reminder when medications were prescribed
Intervention Type
Behavioral
Intervention Name(s)
SMS follow-up
Intervention Description
In addition to conventional treatment, the experimental group received SMS reminding every day until the end of the treatment.
Primary Outcome Measure Information:
Title
Treatment compliance in outpatients with FGIDs
Description
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 Outcome Measure Information:
Title
Improvement of abdominal pain in outpatients with FGIDs
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
RenJiH
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengliang Chen
Phone
86-21-58752345
Email
chenslmd@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
32779141
Citation
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.
Results Reference
derived
Learn more about this trial
SMS Reminders and Treatment Compliance and Efficacy in Patients With FGIDs
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