Functional Gastrointestinal Disorder Screening Program - A Randomized Controlled Trial
Condition: Non-erosive Gastroesophageal Reflux Disease; Functional Dyspepsia; Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Gastroesophageal Reflux; Gastrointestinal Diseases; Digestive System Diseases; Dyspepsia
Study type: Interventional

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.
    

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.
    

Intervention name(s): Counseling
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: Functional gastrointestinal disorder; GERD; reflux; irritable bowel syndrome; Functional dyspepsia; postprandial fullness; counseling; service