Health Related Quality of Life in Functional Dyspepsia

Completed

• Conditions: Dyspepsia

• Registration Number: NCT03321383
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-08-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2017-10
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-22
• Last Update Submitted: 2017-10-24
• Study First Posted: 2017-10-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia