An interventional study of Counseling in Non-erosive Gastroesophageal Reflux Disease, Functional Dyspepsia and Irritable Bowel Syndrome, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-04-26.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Health services research
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.
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
Blood tests will be arranged for patient:
Endoscopy Visit
Endoscopy examinations
FD: Pantoprazole 40mg daily; GERD: Pantoprazole 40mg daily; IBS: Mebeverine 135mg tid PRN before meal, Loperamide 4mg tid PRN (for diarrhea), Metamucil 2 teaspoon bid (for constipation).
Final Visit (8 weeks after endoscopy visit)
The patient will be given an "on-demand follow up within 1 year" option at this 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. If the patient does not come back during this period, his/her case will be closed and a new referral will be required if he/she wants to be taken care by the specialty again.
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:
Counseling at first visit:
Counseling at final visit:
A research personnel who has been working with patients with FGID for at least one year will be responsible for the counseling service.
The random allocation sequence will be obtained from a computer-generated list of random numbers in blocks of 10 supplied by a trial statistician. Concealed allocation is achieved by an independent research staff who assigns intervention group according to consecutive numbers in sealed envelopes. The patients will be invited to participate in the study to assess 1 of 2 potentially helpful interventions. They will be explained that the relative effectiveness of both interventions are unproven and may or may not be beneficial.
In this study, the patients, attending physicians and endoscopes will all be blinded to the randomized arm that the patients are assigned to. The nature of the two arms will also be blinded to them. This arrangement is essential in clinical trials comparing different services or managing strategies and is clearly specified in the Patient Information Sheet.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's planned enrollment of 200 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Present with symptoms suggestive of any of the following FGID according to Rome III Classification:
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:
Exclusion Criteria:
Two extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician
Behavioral: Counseling
Usual management in GI specialty clinic
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.
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
Plan to share: No
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Chinese University of Hong Kong