Functional Gastrointestinal Disorder Screening Program - A Randomized Controlled Trial

NCT01047800 | Completed

• 1 other identifier: FGISP-RCT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Functional gastrointestinal disorder; GERD; reflux; irritable bowel syndrome; Functional dyspepsia; postprandial fullness; counseling; service

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Counseling group

EXPERIMENTAL

Two extra counseling sessions will be arranged for the Counseling group immediately after visiting the physician

Behavioral: Counseling

Control

NO INTERVENTION

Usual management in GI specialty clinic

Interventions

Counseling BEHAVIORAL

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.

Counseling group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Gastrointestinal Diseases; Gastroesophageal Reflux

Interventions

Counseling

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Justin C.Y. Wu, MBChB(CUHK)

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: January 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)