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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Justin Che-Yuen Wu, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01047800
First received: January 12, 2010
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Non-erosive Gastroesophageal Reflux Disease
Functional Dyspepsia
Irritable Bowel Syndrome
Behavioral: Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
Official Title: Effectiveness of Counseling for Functional Gastrointestinal Disorder Patients: A Double-blind Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Rate of attendance to "on-demand follow up within 1 year" option given at Final visit [ Time Frame: 1 year after Final visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of doctor's visits [ Time Frame: 1 and 2 years after Final visit ] [ Designated as safety issue: No ]
  • Use of emergency service [ Time Frame: 1 and 2 years after Final visit ] [ Designated as safety issue: No ]
  • Self-rated health measured by Health status and management scales [ Time Frame: 6 months, 1 and 2 years after Final visit ] [ Designated as safety issue: No ]
  • Social/role activities limitation measured by Health status and management scales [ Time Frame: 6months, 1 and 2 years after Final visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047800

Locations
Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Justin C.Y. Wu, MBChB(CUHK) Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Justin Che-Yuen Wu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01047800     History of Changes
Other Study ID Numbers: FGISP-RCT
Study First Received: January 12, 2010
Last Updated: July 22, 2014
Health Authority: Hong Kong: Department of Health
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Functional gastrointestinal disorder
GERD
reflux
irritable bowel syndrome
Functional dyspepsia
postprandial fullness
counseling
service

Additional relevant MeSH terms:
Digestive System Diseases
Dyspepsia
Gastroesophageal Reflux
Gastrointestinal Diseases
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Deglutition Disorders
Disease
Esophageal Diseases
Esophageal Motility Disorders
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 21, 2014