Functional Gastrointestinal Disorder Screening Program - A Randomized Controlled Trial

Summary

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.

Conditions

• Non-erosive Gastroesophageal Reflux Disease
• Functional Dyspepsia
• Irritable Bowel Syndrome

Interventions

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.

Sponsors & Collaborators

• Chinese University of Hong Kong

  lead OTHER

Principal Investigators

• Justin C.Y. Wu, MBChB(CUHK) · Chinese University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2015-05-31

Completion

2016-12-31

Countries

• Hong Kong

Study Locations