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Health Related Quality of Life in Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT03321383
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ari Fahrial Syam, Indonesia University

Brief Summary:
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.

Condition or disease
Dyspepsia

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.

Study Type : Observational
Actual Enrollment : 124 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Factors Associated With Health Related Quality of Life in Patients With Functional Dyspepsia
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Functional dyspepsia patients at Gastroenterology Clinic in Cipto Mangunkusumo Hospital Jakarta
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321383


Locations
Indonesia
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
Principal Investigator: Ari F Syam, MD, PhD Indonesia University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ari Fahrial Syam, Senior Lecture Gastroenterology Division, Principal Investigator, MD, PhD, Indonesia University
ClinicalTrials.gov Identifier: NCT03321383     History of Changes
Other Study ID Numbers: 16-08-126
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ari Fahrial Syam, Indonesia University:
dyspepsia
health related quality of life

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms