SMS Reminders and Treatment Compliance and Efficacy in Patients With FGIDs
Daily Short Message Service Reminders Increase Treatment Compliance and Efficacy in Outpatients With Functional Gastrointestinal Disorders: a Randomized Controlled Trial
1 other identifier
interventional
176
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2019
CompletedFirst Submitted
Initial submission to the registry
August 3, 2019
CompletedFirst Posted
Study publicly available on registry
August 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedAugust 12, 2019
August 1, 2019
1 year
August 3, 2019
August 9, 2019
Conditions
Keywords
Outcome Measures
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.
week2
Secondary Outcomes (1)
Improvement of abdominal pain in outpatients with FGIDs
week2
Study Arms (2)
The control group
NO INTERVENTIONPatients in this group only received medications without daily text message reminder
The intervention group
EXPERIMENTALPatients in this group received a daily short message service (SMS) reminder when medications were prescribed
Interventions
In addition to conventional treatment, the experimental group received SMS reminding every day until the end of the treatment.
Eligibility Criteria
You may qualify if:
- Patients with newly diagnosed FGIDs according to Rome-IV
- Aged 18-70 years
- With no obvious organic abnormalities
You may not qualify if:
- With organic gastrointestinal diseases
- With psychiatric diseases or are taking psychotropic agents
- With severe cardiopulmonary or other organ diseases
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
RenJiH
Shanghai, China
Related Publications (1)
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.
PMID: 32779141DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor,chief physician
Study Record Dates
First Submitted
August 3, 2019
First Posted
August 12, 2019
Study Start
April 30, 2019
Primary Completion
April 30, 2020
Study Completion
April 30, 2021
Last Updated
August 12, 2019
Record last verified: 2019-08