Functional Gastrointestinal Disorder Screening Program - A Randomized Controlled Trial (FGISP-RCT)
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|ClinicalTrials.gov Identifier: NCT01047800|
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : April 26, 2017
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.
Patients who have symptoms suggestive of FGID including non-erosive gastroesophageal reflux disease (NERD), functional dyspepsia (FD) or irritable bowel syndrome (IBS).
To validate the effectiveness of counseling in patients suffering from FGID.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-erosive Gastroesophageal Reflux Disease Functional Dyspepsia Irritable Bowel Syndrome||Behavioral: Counseling||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effectiveness of Counseling for Functional Gastrointestinal Disorder Patients: A Double-blind Randomized Controlled Trial|
|Actual Study Start Date :||January 2010|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||December 2016|
Experimental: Counseling group
Two extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician
Two extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician in First and Final visits. Each session lasts for about 15 minutes with the following content:
First visit: prevalence of FGID in Hong Kong, chronicity nature of the disease, negative endoscopy result to be expected, time to answer patient's questions
Final visit : prevalence of FGID in Hong Kong (reinforcement), chronicity nature of the disease (reinforcement), explanation of the endoscopy result, management of disease via lifestyle modification, use of medication, need for further or repeated investigation, time to answer patient's questions.
No Intervention: Control
Usual management in GI specialty clinic
- Self-efficacy and decrease in psychological distress measured by Health status and management scales and Patient Health Questionnaire (PHQ) [ Time Frame: 6 months after Final visit ]
- Rate of attendance to "on-demand follow up within 1 year" option given at Final visit [ Time Frame: 1 year after Final visit ]
- Frequency of doctor's visits [ Time Frame: 1 and 2 years after Final visit ]
- Use of emergency service [ Time Frame: 1 and 2 years after Final visit ]
- Self-rated health measured by Health status and management scales [ Time Frame: 6 months, 1 and 2 years after Final visit ]
- Social/role activities limitation measured by Health status and management scales [ Time Frame: 6months, 1 and 2 years after Final visit ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047800
|Prince of Wales Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Justin C.Y. Wu, MBChB(CUHK)||Chinese University of Hong Kong|