Functional Gastrointestinal Disorder Screening Program - A Randomized Controlled Trial (FGISP-RCT)

Effectiveness of Counseling for Functional Gastrointestinal Disorder Patients: A Double-blind Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia; Irritable Bowel Syndrome; Non-erosive Gastroesophageal Reflux Disease
• Intervention / Treatment: Behavioral: Counseling

Detailed Description

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

• Endoscopy examinations

  • FD & NERD patients: oesophagogastroduodenoscopy (OGD) with rapid urea test (RUT) and biopsy of antrum sample for histology to check h. pylori status
  • IBS patients: colonoscopy
• If no organic causes are found to explain for FGI symptoms, the following standard medication will be prescribed for 8 weeks:

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)

• Attending physician manages patient as usual
• Printout of investigation (endoscopy, blood tests) reports given to patient
• Patient completes questionnaires

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:

- Contents include: prevalence of FGID in Hong Kong, chronicity nature of the disease, negative endoscopy result to be expected, time to answer patient's questions

Counseling at final visit:

- Contents include: 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.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Counseling group; Two extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician	Behavioral: Counseling; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Self-efficacy and decrease in psychological distress measured by Health status and management scales and Patient Health Questionnaire (PHQ)	6 months after Final visit
Rate of attendance to "on-demand follow up within 1 year" option given at Final visit	1 year after Final visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of doctor's visits	1 and 2 years after Final visit
Use of emergency service	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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Justin C.Y. Wu, MBChB(CUHK), Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 12, 2010
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (Estimate): January 13, 2010

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: GERD; reflux; counseling; irritable bowel syndrome; postprandial fullness; Functional dyspepsia; Functional gastrointestinal disorder; service
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Dyspepsia; Irritable Bowel Syndrome; Gastroesophageal Reflux; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: FGISP-RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO