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CompletedNCT03321383Updated Oct 26, 2017

Health Related Quality of Life in Functional Dyspepsia

An observational study in Dyspepsia, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by Indonesia University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
124
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dyspepsia

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Keywords

  • dyspepsia
  • health related quality of life
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Functional dyspepsia patients at Gastroenterology Clinic in Cipto Mangunkusumo Hospital Jakarta

Inclusion criteria

  • Dyspepsia patients
  • Normal or non ulcer esophagogastroduodenescopy finding

Exclusion criteria

Exclusion Criteria:

  • History of GI bleeding
  • History of GI malignancies
  • Hepatobiliary tract disease
  • Diabetes mellitus
  • Chronic kidney disease
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
124 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Health related quality of life

    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

    Time frame: 1 month

Secondary outcomes

  1. Anxiety

    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.

    Time frame: 2 weeks

  2. Depression

    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.

    Time frame: 2 weeks

  3. Dyspepsia symptoms severity

    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).

    Time frame: 2 weeks

06

Study locations

1 site
  • Cipto Mangunkusumo Hospital
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
07

References and documents

Publications

  • Hantoro IF, Syam AF, Mudjaddid E, Setiati S, Abdullah M. Factors associated with health-related quality of life in patients with functional dyspepsia. Health Qual Life Outcomes. 2018 May 2;16(1):83. doi: 10.1186/s12955-018-0913-z. PubMed 29720190 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03321383
Lead sponsor
Indonesia University
Responsible party
Ari Fahrial Syam (Senior Lecture Gastroenterology Division, Principal Investigator, MD, PhD, Indonesia University) — Principal investigator
First posted
Oct 25, 2017
Start date
Aug 1, 2016
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Last update
Oct 26, 2017

Study contacts

Ari F Syam, MD, PhD
principal investigator · Indonesia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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