Impact of Stigma on Compliance to Medication in Functional Dyspepsia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Gastrointestinal Disorders
- Sponsor
- RenJi Hospital
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- compliance of psychoactive medicine
- Last Updated
- 5 years ago
Overview
Brief Summary
To date, no study exists that evaluates whether functional dyspepsia patients experience stigma and how stigma may influence adherence. Thus, the investigators aim to evaluate the relationship between functional dyspepsia and stigma, and explore possible ways to improve treatment adherence.
Detailed Description
Due to the functional but refractory nature of functional gastrointestinal diseases (FGIDs), large number of patients who suffer from FGIDs may not be able to fully understand their diagnosis, especially when they were told that they had no organic disease and their symptoms had a psychosomatic origin rather than a gastrointestinal one. Moreover, subjects with FGIDs have concerns and negative perceptions about medications, particularly in the presence of psychiatric comorbidity. Fearing of being labeled as insane or incapability, many patients with psychosomatic symptoms choose to conceal their illness to family, colleagues and doctors. These factors may affect willingness to initiate neuromodulator regimens and treatment adherence.
Investigators
Shengliang Chen
professor, chief physician
RenJi Hospital
Eligibility Criteria
Inclusion Criteria
- •18-70 years old;
- •met the ROME IV criteria for FD;
- •absence of abnormalities in physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), abdominal ultrasonography and upper GI endoscopy within 6 months;
- •absence of H. pylori infection;
- •Generalized Anxiety Disorder Scale (GAD-7) ≥ 1 or Patient Health Questionnaire Depression Scale (PHQ-9) ≥ 5
Exclusion Criteria
- •any evidence of organic digestive diseases;
- •other FGIDs such as IBS;
- •severe psychological symptoms with GAD-7 ≥ 11 or PHQ-9 ≥15;
- •pregnancy or breastfeeding; recent myocardial infarction or cardiac arrhythmias;
- •previous gastric surgery;
- •use of PPIs, psychoactive drugs or other drugs that might affect gastric function within 6 months
Outcomes
Primary Outcomes
compliance of psychoactive medicine
Time Frame: week8
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 Outcomes
- stigma scale(week 0)
- dyspepsia symptom score(week 2, week 4, week 6, week8)
- depression symptom scores(week 2, week 4, week 6, week8)
- anxiety symptom scores(week 2, week 4, week 6, week8)