Impact of Stigma on Compliance to Medication in Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- compliance of psychoactive medicine
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
compliance of psychoactive medicine
时间窗: 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.
次要结局
- 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)
研究者
Shengliang Chen
professor, chief physician
RenJi Hospital