Health Related Quality of Life in Functional Dyspepsia

Factors Associated With Health Related Quality of Life in Patients With Functional Dyspepsia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03321383

Enrollment

124

Registered

2017-10-25

Start date

2016-08-01

Completion date

2017-06-30

Last updated

2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia

Keywords

dyspepsia, health related quality of life

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Health related quality of life	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

Measure	Time frame	Description
Anxiety	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	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	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).

Countries

Indonesia

Outcome results