Health Related Quality of Life in Functional Dyspepsia

Overview

Previous studies reported health related quality of life impairment in functional dyspepsia patients. Anxiety, depression, disease severity, age, and employment status associated with HRQOL in functional dyspepsia patients. However, data about HRQOL in Asian population was limited.This study aimed to evaluate factors associated with health related quality of life in patients with functional dyspepsia.

Full Title of Study: “Factors Associated With Health Related Quality of Life in Patients With Functional Dyspepsia”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: June 30, 2017

Detailed Description

126 functional dyspepsia patients will answer SF-36 HRQOL questionnaire, Hospital Anxiety, and Depression Scale, and Short Form Nepean Dyspepsia Index. Functional dyspepsia and Irritable Bowel Syndrome Rome III diagnostic questionnaire and GERD-Q questionnaire will be used to determine FD type and IBS or GERD overlap.

Clinical Trial Outcome Measures

Primary Measures

  • Health related quality of life
    • Time Frame: 1 month
    • Short Form -36 health survey includes one scale for each of eight measured health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These eight domains aggregates into physical component summary and mental component summary. All health domain scales are scored using norm-based scores ranging 0 to 100 with higher scores indicate better health

Secondary Measures

  • Anxiety
    • Time Frame: 2 weeks
    • The Hospital anxiety and depression scale (Anxiety score) This consists of seven questions on anxiety on 4 point (0-3) response category. Total score range 0-21.
  • Depression
    • Time Frame: 2 weeks
    • The Hospital anxiety and depression scale (Depression score). This consists of seven questions on depression on 4 point (0-3) response category. Total score range 0-21.
  • Dyspepsia symptoms severity
    • Time Frame: 2 weeks
    • Nepean dyspepsia index (NDI) score. 10-item questionnaire measuring symptoms and health-related quality of life in functional dyspepsia. Each item is measured on a 5 point Likert Scale ranging from 0 (not at all) to 4 (extremely).

Participating in This Clinical Trial

Inclusion Criteria

  • Dyspepsia patients
  • Normal or non ulcer esophagogastroduodenescopy finding

Exclusion Criteria

  • History of GI bleeding
  • History of GI malignancies
  • Hepatobiliary tract disease
  • Diabetes mellitus
  • Chronic kidney disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indonesia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ari Fahrial Syam, Senior Lecture Gastroenterology Division, Principal Investigator, MD, PhD – Indonesia University
  • Overall Official(s)
    • Ari F Syam, MD, PhD, Principal Investigator, Indonesia University

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