Effectiveness of Counseling for Functional Gastrointestinal Disorder Patients: A Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Self-efficacy and decrease in psychological distress measured by Health status and management scales and Patient Health Questionnaire (PHQ)
研究概览
简要总结
Background:
Functional gastrointestinal disorder (FGID) is the most common gastrointestinal disease in daily clinical practice. The disease is symptomatic but has no identifiable cause by standard diagnostic tests such as endoscopy. It is characterized by its frequent relapses and thus the disease causes a significant level of stress and anxiety to patients. Due to the complexity and chronicity of the disease, it is believed that appropriate counseling on the nature and management of the disease is necessary to decrease patient's anxiety level and improve quality of life.
Indication:
Patients who have symptoms suggestive of FGID including non-erosive gastroesophageal reflux disease (NERD), functional dyspepsia (FD) or irritable bowel syndrome (IBS).
Aim:
To validate the effectiveness of counseling in patients suffering from FGID.
Method:
Patients recruited to the study will follow the usual management of patients attending the Gastroenterology specialty clinic in Prince of Wales Hospital. Standard blood tests and endoscopy will be performed. Standard medication will be given to the patients for 8 weeks after endoscopy and the patients will come back to the specialty clinic for a final visit.
The patient will be given an "on-demand follow up within 1 year" option at final visit. The patient will decide if he/she wants to come back to our specialty clinic to follow up his/her problem within one year.
Follow-up after Final Visit Follow-up questionnaires will be mailed to patients 6 months, 1 and 2 years after Final visit.
Randomization:
All the patients will be randomized into two groups in First Visit: 1) Control group, and 2) Counseling group. Both groups of patients will follow the above protocol, except that 2 extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician.
详细描述
Patients recruited to the study will follow the usual management of patients attending the Gastroenterology specialty clinic in Prince of Wales Hospital, along with the following protocol:
First Visit
-
Patient signs written consent
-
Attending physician manages patient as usual
-
Blood tests will be arranged for patient:
-
FD & NERD patients: CBC w/ differential count, LFT, TFT, random glucose
-
IBS patients: CBC w/ differential count, LFT, TFT, ESR, C-reactive protein
-
Patient completes questionnaires
Endoscopy Visit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present with symptoms suggestive of any of the following FGID according to Rome III Classification:
- •Non-erosive gastroesophageal reflux disease (NERD) Weekly symptoms of heartburn or acid regurgitation of moderate severity for at least 6 months
- •Functional dyspepsia (FD) Weekly symptoms of epigastric burning sensation, early satiety or postprandial fullness for at least 6 months
- •Irritable bowel syndrome (IBS)
- •Symptoms of abdominal pain or discomfort of at least 3 times a month, in the last 6 months, associated with 2 or more of the following:
- •Improvement with defecation
- •Onset associated with a change in frequency of stool
- •Onset associated with a change in form (appearance) of stool
排除标准
- •Erosive esophagitis (Still eligible for IBS patients)
- •Peptic ulcer (Still eligible for IBS patients after complete ulcer healing)
- •H. pylori positive
- •Organic causes of symptoms, including malignancy, abnormal thyroid function, and inflammatory bowel disease.
- •Previous gastric surgery
- •Pregnancy
- •Illiterate
- •Unable to sign the written consent form • Abdominal surgery within one year prior to joining the program
结局指标
主要结局
Self-efficacy and decrease in psychological distress measured by Health status and management scales and Patient Health Questionnaire (PHQ)
时间窗: 6 months after Final visit
Rate of attendance to "on-demand follow up within 1 year" option given at Final visit
时间窗: 1 year after Final visit
次要结局
- Use of emergency service(1 and 2 years after Final visit)
- Frequency of doctor's visits(1 and 2 years after Final visit)
- Self-rated health measured by Health status and management scales(6 months, 1 and 2 years after Final visit)
- Social/role activities limitation measured by Health status and management scales(6months, 1 and 2 years after Final visit)
研究者
Justin Che-Yuen Wu
Professor
Chinese University of Hong Kong