Functional gastrointestinal disorders Digestive System Disease of digestive system, unspecified
Conditions
Interventions
This study adopts a cluster randomized controlled trial design involving 26 general hospitals in Anhui province, China. These hospitals are randomly assigned by a professional statistician outside the
Sponsors
Anhui Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients 2. 18-70 years old 3. Diagnosed with FGIDs according to Rome IV diagnostic criteria 4. Able and willing, after informed consent, to participate
Exclusion criteria
Exclusion criteria: 1. Serious mental illness, such as schizophrenia or dementia 2. History of gastrointestinal surgery, such as gastrectomy or colectomy 3. Serious or malignant disease confirmed by a clinician, such as kidney failure or tumor 4. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall treatment effect (OTE) of gastrointestinal symptoms measured using a 7-point Likert scale (the question is “How have your gastrointestinal symptoms changed after treatment?”, and the answers include “much better”, “improvement”, “slight improvement”, “no change”, “slight deterioration”, “worse”, and “deteriorated”) at baseline and every 3 months after baseline for 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using structured questionnaires at baseline and every 6 months after baseline for 5 years: 1. Quality of life measured using EQ5D-5L 2. Participant’s utilization of health services measured using a self-designed patient assessment questionnaire 3. Changes in the six objective behaviors measured using a self-designed patient assessment questionnaire | — |
Countries
China
Contacts
Public ContactMengsha Tang
Outcome results
None listed